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Conducting clinical trials in the developing world also enables drug companies to keep costs lower for the trials and therefore renders the final product more affordable. This is an outcome which benefits all individuals in the long run.
Demand for drugs that will treat increasingly common global problems such as diabetes is expanding, and proponents of these trials further add that it is necessary and beneficial that the populations they are tested upon are diverse. This enables researchers to gain a more broad-based sense of the extent to which drugs may affect different populations. Opponents would counter that the diverse range of factors that can affect the results of global trials (such as the effects of poverty) is a detriment to the scientific purity of the results. Furthermore, many individuals in the developing world are attractive to researchers because they do not take additional medications. They can thus provide more…… [Read More]
During Phase III, the drug or treatment is administered under expanded, controlled and uncontrolled conditions in trials of 1,000-3,000 or more persons. They are conducted only "after preliminary evidence suggesting effectiveness of the drug has been obtained" (Understanding clinical trials, 2006, NIH). These studies conduct cost or risk-benefit analysis of taking the drug and compare the benefits of the drug or treatment to existing options (Understanding clinical trials, 2006, NIH). A drug may be effective, but its side effects may be far more severe than current treatments, and if it provides no additional benefit than existing treatments, the drug may not be approved. Information is also collected to determine when the drug is safe to use, and under what conditions. For example, certain drugs such as MAOIs cannot be taken with other drugs or eaten with certain foods without causing severe health problems; some sedating medications should not be taken…… [Read More]
Clinical Trial Outsourcing
Contract Issues in the Outsourcing of Clinical Trials
The increasingly common practice of outsourcing clinical trials for pharmaceutical research and development is fraught with legal and ethical complications, especially as much of the outsourcing finds these clinical trials taking place in underdeveloped countries that lack infrastructure and appropriate civil and social oversight. In a scenario such as the one described, where an unequal partnership shares certain rights to the intellectual property and the physical substance that will be undergoing the clinical trial, new wrinkles in the responsibilities of parties and the necessities of established contracts arise. Looking to current research in the area can help determine the services and contract constraints that will be required to create an ethical and effective clinical trial that serves the immediate research and development needs of the pharmaceutical partnership hiring a central African company to conduct clinical trials.
The services that…… [Read More]
Clinical Trial of Tailored Activity and Eating Newsletter With Older ural Women
Does the report describe an explicit theoretical or conceptual framework for the study? If not, does the absence of a framework detract from the usefulness or significance of the research?
The study uses the Health Promotion Model (HPM) as the primary theoretical model for the study. The study provided the model for the intervention that was used as the dependent variable in this study. The Health Promotion Model is based on the social cognitive theory of Bandura (1986). Bandura's model addresses four areas of cognition that must be in alignment for the change to a place. These are the perceived benefits of the change, perceived barriers to the change, a person's belief in their ability to change, and interpersonal influences that will affect the change. The researcher explicitly explained the theoretical framework of the study to their audience.…… [Read More]
Efficacy of Adrenaline in Out-of-Hospital Cardiac Arrest
Levels of evidence
Issues with Prior Studies
Efficacy of Adrenaline in Out-of-hospital Cardiac Arrest
Levels of evidence
andomized control trials
andomized clinical blinded trial
This objective of this paper was to find out whether adrenaline is efficient in out-of-hospital patient. Therefore, information here within can be of help to investigators on the same, students and any other reader. The study uses simple English, which makes it understandable to a wide variety of readers.
For this study, the electronic databases including Pub Med, EmBase, Medline, Cochrane, and Google Scholar were searched to identify relevant literature. The study used some search terms for the strategy such as, "efficacy of adrenaline, effectiveness of norepinephrine and the effectiveness of vasopressor" and "heart arrest, cardiac arrest and therapy," "cardiopulmonary resuscitation, cerebral resuscitation"…… [Read More]
Clinical Trials: egulatory Considerations and International Harmonization
Clinical trials are experiments that are carried out in clinical research. They are designed to provide knowledge on detection, prevention, and treatment of diseases as well as other biomedical interventions and new treatment discoveries. One important aspect of clinical trials is the generation of data on safety and efficacy, which require that sponsors get the approval of regulatory bodies and ethnic committees in every country they operate in. However, sometimes, language and culture dissimilarities present challenges that inhibit their effectiveness in foreign territories. This text takes a look at bridging studies and harmonization technologies which are used to reduce the adverse effects that may be brought about by globalization.
Discussion 1: Bridging Studies
Do you think that bridging studies should be required for the development of drugs that companies plan to market in other cultures?
Drug manufacturers today rely on the globalization of…… [Read More]
Clinical Trial Management Systems
Though all four systems of Clinical Data Management (CDM) seem to possess identical functionality, it appears that Perceptive Informatics is more useful, as it requires complex IT infrastructure for its functioning. CDM represents a crucial clinical research phase that generates superior, statistically sound, and reliable information from the clinical trial phase. This aids in drastically reducing the timespan between drug development and marketing stages. Clinical trial intends to answer research questions through data generation, to disprove or prove a hypothesis. Generated data's quality is a crucial contributor to the study's outcome. CDM denotes subject data collection, management, and cleaning, according to regulatory standards. CDM processes' basic aim is providing superior quality data, through minimization of missing data and errors to the maximum possible extent, and gathering maximum possible information for analysis. Maintenance of audit trials of CDM activities is extremely important in case of regulatory submission…… [Read More]
Clinical esearch Process
Advances in esearch
The Common Fund programs of the National Institutes of Health (NIH) include the POMIS (Patient-eported Outcomes Measurement Information System) initiative (NIH, 2013). The POMIS initiative seeks to exploit the creative potential of researchers and clinicians, for the purpose of developing new methods for reporting patient outcomes; however, in contrast to more quantitative measures, such as laboratory tests and radiological findings, the POMIS initiative is focused on outcomes from the perspective of patients. These outcomes can include patient reports of changes in pain levels, activities of daily living, cognitive performance, social connectedness, and psychological health. These outcome measures will be used to inform researchers and clinicians about an intervention's effectiveness, from a relevant and potentially more meaningful perspective.
Passage of the 2010 Patient Protection and Affordable Care Act provided funds for the creation of the Patient-Centered Outcomes esearch Institute (PCOI), a non-profit institute dedicated to…… [Read More]
Oversight of Clinical Trials
What are the obstacles involved with instituting institutional oversight in developing countries?
The biggest challenges with instituting institutional oversight in developing countries are: culture and the lack of regulations / enforcement. In the case of culture, many countries will have different ethical attitudes about various clinical trials. This is because most businesses do not have to meet as stringent guidelines and subjects are not provided with full disclosure. These issues are problematic, as many nations may have existing regulations in place. Yet, there is a lack of will to address these causes, based upon the traditions embraced by the medical community. ("ICH Guidance," 1997) ("The Nuremberg Code," 2000)
The lack of regulations and enforcement; is from many developing nations not conducting clinical trials. In these kinds of situations, medical research is something that is relatively new. This means that there is a lack of resources, regulations…… [Read More]
Technology Aid in the Process of Clinical Trials
Capstone Project title: Using technology in managing data in clinical trials
We will start our paper by discussing "Clinical Data Management" or CDM, which is an important phase in clinical research. It is a process through which reliable, high-quality and statistically accurate data is generated from clinical trials. This drastically reduces the time taken by the process, from when drugs are developed to the time they are marketed. The CDM team members play an active role throughout the process, from the beginning to the end. They are required to have sufficient knowledge about the maintenance of CDM processes quality standards. There are several procedures in the process such as Case eport Form (CF) and its annotation, data entry, designing a database, validation of data, management of discrepancies, medical coding, extraction of data and data locking. During a trial, these procedures are assessed…… [Read More]
Globalized Clinical Trials
As a part of a research team within a research consortium that is preparing to conduct a large-scale trial in multiple locations around the world, it is important to fully understand the advantages and challenges that are involved in managing globalized clinical trials. To this end, this paper reviews the relevant literature concerning these issues, followed by a summary of the research and important findings concerning the advantages and challenges that are associated with globalized clinical trials in the conclusion.
The Advantages of Globalized Clinical Trials
The trends are clear and there has been a steady increase in the use of globalized clinical trials by the biopharmaceutical industry in recent years, especially in several developing regions of the world including Latin American, Asia, and Central Eastern Europe, where medical care has languished despite efforts by national and international authorities to deliver modern healthcare services (Glancszpigel & acaro,…… [Read More]
Technology in Managing Data in Clinical Trials
Even a casual observer will undoubtedly make note of the range of high-tech solutions that are causing disruptive change in the process of clinical trials. From webinars and multi-day meetings to an expanding pool of literature, technology has been establishing itself as the key to an era fixated on measurable improvements like accelerating the research start-up phase, restructuring clinical trial information transmission, and overhauling research monitoring. And the issue is no longer a distinct solution to apparently intractable glitches; instead, it revolves around sharing real-time information captured by these solutions for facilitating strategic decision-making by collaborators, with regard to a research's status as it is actually progressing. This constitutes a drastic change from the conventional paper-based techniques that underlie the industry's costly and time-consuming methods of carrying out international clinical research, in which data quality assessment depended on near-database locking or onsite monitoring,…… [Read More]
regulatory requirements involved will be covered. The report will also include an answer to the question of what three of the file documentation requirements are before a study can be begin at a given site. While the rules and regulations regarding clinical trials may seem arduous and aggravating, they exist for a very good reason.
As explained by the class PowerPoint, the role of the Investigator's Brochure is to offer a compilation of all clinical and non-clinical information that is relevant to a study. It also serves as a reminder and review of the protocol that must be followed. That protocol includes the rationale for the study as well as the compliance that must be part of the study. For the sponsor in particular, the Investigator's Brochure serves several specific needs. These needs include all information known an investigational drug, whether serious or adverse events are "expected" or "unexpected" during…… [Read More]
outsourcing clinical trials that individuals and organizations looking to do so need to consider. Many of these different facets pertain to the contracts provided for this particular process. The principle services that one will need to procure, of course, are those of the research company that will be utilized to outsource the clinical trials. In the situation presented in this assignment, there are two individuals, one of which has the patent for a potential Alzheimer's compound and another that has the research skills. The first thing that this fledgling company needs to do is outline exactly what will be tested and how it will be done. This information itself must go into the contract that the party that is going to actually conduct the clinical trials needs to see. It is pertinent for the pharmaceutical company to be very specific about what sorts of these things it is testing for…… [Read More]
esearch activities, whether clinical trial based, experimentally designed, or product oriented, must exhibit and command interest, enthusiasm, and passionate commitment. To this end the researcher must catch the essential quality of the excitement of discovery that comes from research well done. The first step in the attainment of the desired research goal is to develop a scientific approach toward that which is being investigated. A requirement within the scientific approach best-fit format that is oftentimes misunderstood, and consequently wrongly applied, is that of sampling.
In a rather philosophical approach to sampling Ohlson (1998) states that sampling is " ... But part of the whole. Check to make sure I fairly represent my larger connection " (p. 27). With these words Ohlson is informing the research enthusiast that sampling alone can skew testing results, infuse uncontrollable error into statistical processes, and violate the empirical premise under which the research investigation…… [Read More]
Since modern medicine can sustain patients with proper medical follow-up for years, it becomes incumbent on the profession to follow the patients and provide them with the knowledge and tracking to insure that they are observing the procedures and medications which prolong their quality of life. Given hospitals' short-term orientation with the patients, there is a need to bridge patient care before, during and after acute-care visits.
While there are some nursing specialties which can be regarded as solely hospital- or community-based, many of the specialties call for a more holistic notion of patient care. y combining the CNS and NP specialties, this profession has a better chance of assuring better patient outcomes, and a better quality of life for the patient.
ennett, .J. (1998). Psychiatric mental health nursing: thriving in a changing environment through outcomes-based measurements. Semin. Nurse Manage., 144-148.
erger, a.M.-F. (1996). Advanced practice roles for nurses…… [Read More]
The American Association of Colleges of Nursing (AACN) and the Council on Graduate Education for Administration in Nursing (AACN, 1996; Dienemann & Aroian, 1995) operationally define the professional nurse as one who has been prepared with a minimum of a baccalaureate or higher degree in nursing. (Feldman & Greenberg, 2005, p. 219)
These were necessary requirement in the 90's. Now in an ever increasing age of need for more highly educated professional, the Clinical Nurse Leader armed with a Master's degree or better, is more adapted to handle a wide range of situations and create a fulcrum from which to balance all the staff in a given unit.
Clinical Nurse Leader
Kennedy, M.S.. (2004) Introducing the Clinical Nurse Leader. American Journal of Nursing, 104 (10), 22.
This article is a report regarding the decisions calling for a new role for nurses. The American Association of Colleges of Nursing…… [Read More]
International Clinical Harmonisation
PROPER SYSTEMS IN PLACE
The International Congress Harmonisation
WHO Principles of Good Clinical Practice
Clinical research is conducted to insure the safety and efficacy of health and medical products and practices (WHO 2002). In the past, randomized controlled trials gave most of the information about the safety and efficacy of these products and treatments. Randomized clinical trials were considered the foundation of evidence-based medicine but reliably only when conducted according to principles and standards. These principles and standards comprise good clinical research or GCP. The guidelines were created to help national regulatory authorities, sponsors, investigators and ethics committees to implement GCP for overall clinical research. These were based on the guidelines provided by major international organizations, such as the International Conference on Harmonization or ICH GCP, and used as reference (WHO).
GCP incorporates accepted and established ethical and scientific quality standards complied with for the design, conduct,…… [Read More]
In other words, p values correspond to statistical significance, while NNT corresponds to clinical significance. In clinical trials, statistical validity reflects the theoretical basis of the study, with hypotheses being formulated and quantified in terms of likelihood. Clinical significance is concerned with the practical outcome of trials, and with the results of actual treatment and how this relates to the hypotheses that are proven or void.
In nursing practice, both statistical and clinical significance play an important role in research. In practice, however, it is clinical significance that should have the greatest impact upon nursing practice. Clinical significance provides actual data from research conducted to determine such effects. It concerns the outcome of trials, while statistical significance is more concerned with determining new research and the likelihood of success before trials have been conducted.
Indeed, Davidson notes that an advantage of NNT is the format of its results --…… [Read More]
Ethical Factors in Clinical Testing
The conduct of the medics during their course of duty is regulated and governed by the established regulations relating to their profession. The basis of all these regulations is mainly to safeguard the rights of the patients. The patients must be accorded the utmost respect and handled in a dignified manner that makes them feel respected. It also covers what sort of equipment to be used in the case of an operation. Besides, regulations in the medical fraternity also cover the conditions of the treatment facilities such as the hospitals. The level of hygiene among other conditions is put into consideration. This paper focuses on the ethical issues that surround the observation of patients with Obstructive Sleep Apnea condition in the United States. This is a medical condition where a patient has difficulties breathing during sleep. However, it is unknown to these patients and can…… [Read More]
Clinical and Safety Databases
Clinical databases and safety databases are some of the most common types of databases utilized by clinical and drugs safety organizations to comply with different data standards. These databases differ significantly in various ways including the fact that safety databases have much more strict requirements for quality and safety. While safety databases are derived from clinical databases, they vary in relation to the kinds of data included in them, their maintenance, and how and when they are used in data management. Despite their differences, an important aspect of clinical data management process is reconciling the two databases. Clinical esearch Associates (CAs) play an important role in reconciling clinical and safety databases. However, CAs role in this process may be influenced by the nature of adverse events, progress of the clinical trial, and the use of coding dictionaries.
CA ole in econciling these Databases
As previously indicated,…… [Read More]
old, the profession of clinical psychology is "one of the most vigorous fields of psychology," (eisman, 1991, p. 3). Clinical psychology refers generally to both social science research and application of that research to achieve specific clinical goals related to mental health. Since its inception in the 1890s, the field has changed and evolved dramatically (Benjamin, 2005). Earliest forms of clinical psychology included working with asylum patients, which often entailed using a variety of techniques that are now deemed unethical or harmful. The rise of psychoanalysis based on Freud's teachings led to the 20th century being an era in which talk therapy prevailed. esearch on different models of talk therapy has informed best practices in general. However, recent changes to the field of clinical psychology attempt to distinguish between the types of quantifiable evidence that can be gained from empirical research using psychopharmacological interventions on the one hand and less…… [Read More]
double blind trial. This is a study where neither the researchers or the participants know what they will receive. First and foremost, it removes any potential for bias, as there are no preconceived notions from the participants or those studying the reactions of the trial. Such studies often also "follow less restrictive methodological standards than phase III studies in terms of patient selection, comedictation, and other design issues," (Muller, 2011). Essentially they have greater room to better replicate real world scenarios. They are also much more able to be generalized than studies with more restrictions. However, there are also some downsides to double blind trials. For example, there is a much greater variance that the research will have to deal with. This is "caused by the different kinds of confounders as well as problematic design issues" that can lead to "wrong conclusions," (Muller, 2011). When there are issues it is…… [Read More]
Global Healthcare Ethics and the andomised HIV Trial
Healthcare professional face a range of ethical issues in the pursuance of their vocation. In the context of HIV research and the conducting of research among vulnerable population, such as poor expectant mothers in developing countries, the compete of global health ethics should provide a foundation for the assessment of ethical practices, both in planning, undertaking, and reviewing the work (WHO, 2014; Stapleton et al., 2013). Global health ethics is an interdisciplinary field, which covers not only health research, but also issues such as the provision of healthcare, and development of health policy, with the aim of understanding the moral values which should be implemented at a global level, undertaken utilising a predominantly geographic approach to macro level health issues (Stapleton et al., 2013). In this context, global health ethics is primarily concerned with issues such as pandemics, the effects of natural…… [Read More]
Programs for Parents of Infants and Toddlers: ecent Evidence From andomized Trials
My initial thoughts and feelings were:
Infancy is a very important stage in children's development. It is at this stage that children are most receptive to both mental and physical change and they are at greater risk of potentially harmful influences than their older counterparts. Infants also get affected much more by parental disruptions than older kids. It has been shown that parent-child interactions during the early stages are great predictors of several late and early developmental outcomes. Lending parents support in coming up and implementing good parenting skills can lead to great child development (Pontoppidan, Klest & Sandov, 2016). Since the child is most malleable during infancy, experiences at this stage shape the child's behavior, wellbeing and brain development and so the effects can last for the entire life of the infant. Parenting interventions given to newborn…… [Read More]
IRB's add a certain and authentic stamp of approval for research and clinical trials. This system is by no means perfect, as there are countless examples of how IRB's failed, but in this particular instance where a Central African country may be exposed to a vaccine, this oversight is deemed necessary. The IRB needs to understand what is the purpose of these tests and how the population of this vulnerable nation may benefit from this research. Historically, this region of the world has been used as a virtual Petri dish for Western scientists wishing to test their new medical breakthrough. Caution is necessary.
The ethical conflicts are obvious. There are profit motives in mind for the vaccine, as they are valuable commodities in many parts of the world. The IRB can act as an ethical buffer by creating a circumstance where the research can be done humanely, and with a…… [Read More]
DSM diagnostic criteria have long been a source of criticism. McGorry, Hickie, Yung, Pantelis, and Jackson (2006) point out some basic deficiencies of the DSM diagnostic system. First the authors state that the function of a diagnosis is to state what treatment should be applied or predict the prognosis of the condition. These are certainly functions of a diagnosis, but a diagnosis has broader implications. First and foremost the idea of having a diagnosis is to take a series of related signs and symptoms that hang together consistently and label them so as to facilitate communication between health care professionals. A diagnosis alone is useless unless it allows professionals to communicate about the same entity. Then descriptions of course, treatment, and prognosis can follow.
McGorry et al. charge that in the DSM system the clinical features that occur early in the course of the disorder are not distinguished from those…… [Read More]
Clinical Trial NCT01504854
The number of Americans with Alzheimer's disease and other dementias will grow as the U.S. population age 65 and older continues to increase. It is projected more than 3 million people aged 85 and older are likely to have Alzheimer's, when the first wave of baby boomers reach age 85 in the year 2031 (Alzheimer's Association, 2015). By 2025, the number of people age 65 and older with Alzheimer's disease is estimated to reach 7.1 million -- a 40% increase from the 5 million who are age 65 and older currently affected (Alzheimer's Association, 2015). Alzheimer's disease is the most common type of dementia and is projected to be one of the most prevalent illnesses with our older adult population in the future. Alzheimer's disease remains 100% fatal and there is no cure for the disease; however, there are medications that are believed to be able to…… [Read More]
Forensic and Clinical oles and Assessment
While psychologists and psychiatrists may engage in both clinical and forensic practice, it important to recognize that clinical and forensic practice are distinct areas of practice. This means that the role of the forensic and clinical practitioner differs in several ways: "who the client of the psychologist is the nature of the relationship between the psychologist and the individual being evaluated, and the psychologist's approach to the material provided by the individual" (Packer, 2008). Moreover, it also means that the professional assesses the individual differently. These differences include: the purpose of the assessment, the goal of the intervention, and psycho-legal vs. psychological assessment. While the differences may seem clear, the reality is that even forensic evaluations can lead to the establishment of the type of relationships that develop in clinical practice, making it difficult for health care professionals and for their clients to differentiate…… [Read More]
Early Detection and Management of Diabetic Neuropathy in a Clinical and Homecare Setting
The objective of this study is to examine early detection and management of diabetic neuropathy in a clinical and homecare setting and specifically through examination of articles published after 2002. The information from each source will be summarized listing the strengths and weaknesses of each article in separate paragraphs. As well, this work will utilize table or graphs to present the findings.
O'eilly, Caryl Ann (2005) Managing the Care of Patients with Diabetes in the Home Care Setting, Diabetes Spectrum, July 2005. Vol. 18. No. 3. etrieved from: http://spectrum.diabetesjournals.org/content/18/3/162.full
The work of O'eilly (2005) reports that more patients than ever before are released earlier from hospitals and rehabilitation center and that those with diabetes are included in this trend. Diabetes is reported to be ranked second following congestive heart failure as the primary diagnosis at…… [Read More]
Ethical Dilemma: case study of clinical trial on a child
The field of medicine and research has been surrounded by issue of experiments in order to have the conclusive result of the effectiveness of a drug or otherwise. These results can only be obtained if the drugs are at times used on human beings with the real medical problem that the experiment seeks to find solution to. The problem of ethical dilemma often comes in at such stages on whether to go ahead to experiment on the effectiveness of the new drug or not.
Ethical dilemma refers to the situation that is deemed complex since it involves some element of mental conflict between moral imperatives that is one goes ahead and obeys one, it will mean the transgression of another (Braunack-Meyer A.J., 2001). The individual does not have a clear cut direction on which option to go for, despite there…… [Read More]
According to these authors, the fatal tragedy could easily have been avoided by taking more time for more focused and carefully planned clinical trials. According to this view, it was unethical to test Tysabri in the way it has been done, and furthermore irresponsible to enter it into the market before all side-effects were ascertained.
3. Interested parties: The interested parties in this case include Walter Smith, Anita's widower, as well as Cambridge biotechnology and Elan Corp. From Smith's point-of-view, the companies are at fault for causing harm to his wife, and potential harm to many others using the drug. His current assertions regarding the reentry of the drug into the market appear to be well thought out and mature, focusing on the future benefit of patients rather than on his own need for revenge.
From the point-of-view of the companies, the drug is developed to help those suffering from…… [Read More]
Technology in Managing Data in Clinical Trials
Technology can assist in several ways in a healthcare setting. From use of big data to use of technology for effective disease management, technology gives hospitals and other healthcare facilities a chance to examine patient information faster and easier. Because clinical trials are an important aspect to pharmaceuticals and thus disease management, research needs to point in the direction of how technology can offer a means of managing data efficiently and effectively. Big data is one such use for technology and can be used in clinical trials, especially clinical trials with a large number of participants.
In a 2014 study, researchers attempted to identify six use cases where there can be introduction of big data use. "Six use cases where some of the clearest opportunities exist to reduce costs through the use of big data: high-cost patients, readmissions, triage, decompensation (when a patient's…… [Read More]
ecruitment and etention
For any clinical trials, there are bound to be subjects who volunteer to take part in the trials and in recruiting and working with these subjects, it is important to ensure that they are treated as ethically as possible.it is also important to ensure that the procedure gives the best possible results which reflects the true effect and response from the subjects. Due to the stringent nature of most recruitments, there are factors that are bound to affect the process in a positive as well as in a negative manner.
The positive aspects that often affect recruitment and make it successful are such as the awareness of the candidates on the expectations that the investigator has on them hence reducing anxiety and uncertainty hence high rates of turn out and participation that will make the recruitment process end up with quality subjects. The other positive factor is…… [Read More]
The sample population for the stomach cancer trials included 594 patients that were Her2 positive. It is not known if patients in the stomach cancer trial included both males and females. Exclusionary criteria were not made available for either of the studies. All of the patients were receiving standard chemotherapy treatments, in addition to receiving Herceptin (Pollack, 2009). The sample populations for these studies were large for a clinical trial. Many times, it is difficult to find patients that fit the criteria for inclusion in the study. This was not a problem for these studies. The sample population of the study improves the validity of the study and confidence in the drug to be effective in patients that meet the criteria for administration of Herceptin.
The study design in both cases used a comparative study. One group was the test group and would receive the treatment being tested, in this…… [Read More]
Therapy was discontinued due to an adverse event in 11% of EVISTA®-treated women and 9% of placebo-treated women. Common adverse events related to EVISTA® therapy were hot flashes and leg cramps. Hot flashes were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter.
Cholestyramine causes a 60% reduction in the absorption and enterohepatic cycling of raloxifene after a single dose. Thus, co-administration of cholestyramine with EVISTA® is not recommended.
Overall, raloxifene exerts similar positive on bone mineral density and bone turnover as other SEMS and estrogen therapy. However, the reduction in fracture risk is improved with SEMs vs. estrogen (Nakamura 632).
Overall, administration of calcium and vitamin D is more effective and economical than any approved drug for postmenopausal osteoporosis. The annual cost of calcium and vitamin D treatment is $22 compared to $255 for estrogen,…… [Read More]
There are a number of points of interest regarding "Massage therapy in post-operative rehabilitation of children and adolescents with cerebral palsy - a pilot study." On the whole this is an extremely well-organized article, which is one of its primary strengths. The different sections and phases of the research are well documented. There are a variety of tables that elucidate several components related to the literature review, the results, and the particulars of the subjects considered in the research. However, there is more than one area of the study in which the researchers could have benefited from the use of more substantial effort and a more thorough methodology, which is certainly reflected in the results and the conclusion.
The central weakness of this study is the fact that all of the results were based on research performed on just six subjects. To the credit of the researchers they…… [Read More]
International Congress on Harmonization
Clinical research guidelines
There are various bodies that are concerned with the stipulation of guidelines and rules that need to be followed within the medical field and in specific the clinical research areas. The guidelines have been summarized by the International Conference on Harmonization (ICH) into five major areas: those dealing with quality, safety, efficacy and multidisciplinary topics. Within the patient care discipline, guidelines are designed predominantly to support decision making process and the content of these guidelines are based on data from the evidence based approach that has been gathered over time hence has a wide application and reach. Evidence-based care has been gaining ground in the recent years, propagated by the clinicians, managers and even politicians who are concerned about the quality standards. This has further heightened the need and requirement of standards among the practitioners in the healthcare sector (Open Clinical, 2013).
There…… [Read More]
However, if it were the case that the Chinese legal system protected the innocent and executed only those criminals who have been properly, duly, and fairly convicted and sentenced for crimes appropriately punished by execution, it is much harder to argue against the use of their organs to benefit society. From an objective point-of-view, once a person dies, it is wasteful not to use his or her organs to benefit living people. The attachment we have to the body after death is primarily a function of social learning and nonsensical superstition in the first place. Logically, it would be ethically permissible, to require that organs be harvested from all deceased persons once their families have had the opportunity to pay their respects.
The ethical problem in this case is much more about the way that Chinese citizens become prisoners in the first place and the way that the decision to…… [Read More]
Suitable P-Value for a Clinical Trial
Statistical testing to determine whether results are significant is extremely useful in all types of research. In most cases, where a significant level, or p-value, is being chosen, a p-value of .05 is deemed to be sufficiently accurate. However, while this may be suitable for many types of research, it may be argued that in clinical trials from drugs, a lower p value may be more appropriate, due to the nature of the research. To understand this, it is necessary to understand what the p-value is, what it signifies.
The p value gives a probability, but is easy to misunderstand, as it indicates the level of support for the null hypothesis, with the probability level used to determine whether to accept or reject the null hypothesis. The p-value provides the probability of gaining an effect at the same level if the null hypothesis is…… [Read More]
new respiratory drugs that have been approved for medical use over the past decade. The paper will highlight the diagnoses of the drugs i.e. when and why it is prescribed, how it is meant to be used and how often, its side effects, the impact for a missed dose or an overdose along with any other relevant information that will add depth to it appropriate use.
The main purpose for the respiratory drugs is to help cure the ailments directly or indirectly related to the functioning of lungs or general breathing of an individual. There are numerous sectors where studies on new respiratory drugs can be carried out and some of the most recent studies to include this particular aspect include allergies, asthma attacks, Acute espiratory Distress Syndrome (ADS), pneumonia and sinus infections.
In this paper we will focus on the following new respiratory drugs: Arcapta, Daliresp, Dulera, Tyvaso, Alvesco,…… [Read More]
This is particularly the case in sub-Saharan Africa where clinicians have often come to rely on signs and symptoms alone to make diagnoses." (Nicoll, Walraven, Kigadye, Klokke, 1995)
The laboratory environment is critical to administering testing to determine population rates of HIV / AIDS throughout nations and perhaps continents where the lacking of resources facilitates a substandard environment for care. In the case of the African nation of Mozambique, which perhaps can be understood as a case indicative of the environmental assessment one would find throughout Africa and therefore, can be labelled to be a median statistical nation. A nation representing the median would indicate that half of the population nations that are categorized as resourced deficient, half would be above Mozambique in terms of resource allocation and half would fall below.
esearch into the quality of HIV / AIDS case-detection and case-reporting system in Mozambique was conducted by (Chilundo,…… [Read More]
Pharmaceutical industries have to operate in an environment that is highly competitive and subject to a wide variety of internal and external constraints. In recent times, there has been an increasing trend to reduce the cost of operation while competing with other companies that manufacture products that treat similar afflictions and ailments. The complexities in drug research and development and regulations have created an industry that is subject to intense pressure to perform. The amount of capital investment investments required to get a drug from conception, through clinical trials and into the market is enormous. The already high-strung pharmaceutical industry is increasingly investing greater amounts of resources in search of the next "blockbuster" drug that can help them gain market position and profits. Laws, regulations and patents are important to the industry while spending billions of dollars in ensuring the copyright of their products.
It is the intention of this…… [Read More]
PICOT Question and its Significance
The PICOT question is: Does mindfulness meditation (I) reduce long-term risk factors and suicidal behaviors (O) among psychiatric patients (P) versus those who do not participate in the meditation programs (C)? This is of great significance to the nursing practice because psychiatric disorders are risk factors that cause an increase in the probability of a suicidal occurrence. As a result, it is imperative for psychiatric nurses to comprehend how to pinpoint such risk factors and institute a clinical practice setting that dissuades suicide. More importantly, nursing practice encompasses the execution of best practices for generating a clinical setting that diminishes risk such as mindfulness meditation.
Summary of Literature Review
The mindfulness meditation theory is deemed to the most prospective one in treating addictive disorder patients. The safety of these models is guaranteed if carried out in the framework of clinical studies. In recent periods, associated…… [Read More]
" Concerning the type of complementary strategic alliance, it is a horizontal one, because it is formed "when partners who agree to combine their resources and skills to create value in the same stage of the value chain," it is focused "on long-term product development and distribution opportunities" and "the partners may become competitors which requires a great deal of trust between the partners."
The answer to the second question is "no," it's not a "competition response strategy" because the two companies are not really competitors, even if the profile for both company is pharmaceutical. Excel research can be consider in this case as an ally, a support for Century Pharmaceuticals, and even as a consultancy company that works for C.P.
The answer to the third question is "yes," it can be an" uncertainty reducing strategy" because if it functions as it is established, it can reduce the uncertainty about…… [Read More]
Internet Information Quality
hitehouse.gov vs. hitehouse.net
hitehouse.gov, under first impressions is accurate, far more professional, and updated. In fact, whitehouse.net is outdated and still has George . Bush as the President. hitehouse.gov is extremely informative, but focused on the current President, Barak Obama, and his agenda. The site is divided into photos and videos of conferences, appearances, and there is a briefing room that focuses on the major issues of the day. The site is appropriate for education, it has information about the way the government worlds, and about the topics that are in the news -- immigration, gun violence, energy policy, and more. The site is current with top political news of the day, the visits, and the travel plans of the President and his staff. There is a link for email updates, contact information, and a way to receive answers back from various departments of the government. Ironically,…… [Read More]
Treatments for Rosacea
Rosacea is a medical condition characterized by reddening of the skin. The face primarily will turn red in hue. Sores may appear on the skin as well. The face may also swell to some degree. It is an unfortunate condition where patients not only have to deal with the illness itself, but also with psychological ramifications from feeling unattractive due to the skin pigments or lesions. Although there is currently no cure for Rosacea, scientists have researched various treatments to help patients suffering from the condition.
In the article, "Treatment of Rosacea with Intense Pulsed Light," researchers Papageorgiou et. al consider how ultra violet and pulsed light might positively treat skin conditions like Rosacea. During this particular experiment, the researchers tested 34 patients who were given treatments every three weeks for a total of twelve weeks. More than 70% of patients experienced at least a 50% reduction…… [Read More]
Patient Access to Experimental Drugs
Experimental drugs are being used in treating cancer and other life-threatening diseases in the hopes that effective cures and treatments can be identified. There are however, ethical questions relating to the use of experimental drugs and this work seeks to answer the question that asks whether patients should have access to experimental drugs and to answer why or why they should not have this access.
Experimental drugs have carved inroads to treating cancer patients and most recently; this has been reported in the form of a drug that serves to "neutralize two mechanisms cancers need to survive." (Coghlan, 2012) The new drug is Cabozantinib. This drug is reported by one individual interviewed in this study to have been used by a family member who died while taking the drug for non-small cell carcinoma in the form of lung cancer. When asked the question…… [Read More]
With respect to the McGuckin studies neither randomization nor sample selection is ever discussed. In fact sampling per se is not presented except for cursory mention in the results section. Again, without proper identification as to the sampling method implemented, the reader is ever cautious as to how legitimate the results will be. Not wanting to pre-empt the discussion on statistical methodology, mention must be made at this time with respect to the Poisson egression statistical tool selected for use in these two studies in terms of sampling. This particular regression technique, if utilized properly, requires the sample size to be determined on the basis of the square root transformation of the Poisson random variables. More specifically, the formula for calculating the sample size of the Poisson variables is as follows:
The data received from this calculation will give the research investigator the number of sampling units per…… [Read More]
Measurements Health Care equired esources Media Course Media: Organizational Systems Leadership
The metrics used in the balanced scorecard and dashboard are both qualitative and quantitative, and can result in improvement in health care services (Frith et al., 2010, p. 10). As such, they play a significant influence in the nursing practice for different organizations, because they provide an objective means of measuring various aspects of health care services. Specifically, the balanced scorecard and dashboards stratifies health care into four primary components: training for health care workers, resources for facilities, provision of service and community satisfaction (Chan et al., 2010, p. 709). These metrics are principally used to inform health care practitioners about specific areas of improvement, or those in which they are providing excellent service and resources. In several instances, the metrics for the individual areas of analyses were developed by evaluating and comparing national standards (Chan et al., 2010,…… [Read More]
This prescription medicine is a hard capsule, which comes in sizes 1 and 3 and in 20 mg and in 10 mg (MIMS, 2010). Manufactured by Clonmel Healrhcare Ltd., its active ingredient is fluvastatin. Size 3 has 20 mg of the active ingredient and with a white body and a blue cap. Size 1 has a white body and a green cap (MIMS).
Lochol is indicated for primary hypercholesterolaemia and mixed dyslipidaemia or high cholesterol (MIMS, 2010). It supports the diet of individuals suffering from high total cholesterol levels and low density lipoprotein cholesterol levels and their modified diet and other treatments are insufficient or inadequate in managing the condition (MIMS).
Lochol is also prescribed to patients suffering from coronary heart disease and for the adjust prevention of coronary conditions, which can follow coronary transcatheter treatment (MIMS, 2010). These include cardiac death, myocardial infarction, which is not fatal,…… [Read More]
The clinical trial team includes doctors, nurses, social workers, data entry technicians and other health care professionals (NWHRC 2005). They review a participant's health history and current medical intakes before the trial begins. They impart adequate information and instructions about the clinical trial, monitor each participant in the conduct of the trial and may contact the participant after the conduct of the trial.
Clinical trials or researches may also be open-label, placebo-controlled, double-blinded or randomized. They consist of four phases. Phase I establishes the maximum safe dosage; Phase II, its effectiveness; Phase III, its use on a broad population; and Phase IV, post-FDA insights on the effects of its long-term use (NWHRC).
From 1999 to 2000 alone, the Food and Drug Administration approved 73 new medications (NWHRC 2005). These included drugs for HIV, cancer, heart attack and Alzheimer's disease. As of 2000, Medicare covers many of the costs involved in…… [Read More]
MacPherson, Thorpe, and Thomas (2006) reported an interesting qualitative study on the use of acupuncture in the treatment of low back pain. They report the results of a qualitative study nested within a large quantitative study (there were actually tow qualitative studies performed but the current study only addresses one of them). The quantitative study design was one of a large randomized controlled trial that compared acupuncture against typical general practitioner care. The study was carried out York between the years 1999 and 2003. The acupuncture treatment for the study was founded on the principles of Traditional Chinese Medicine (TCM) using six acupuncturists who all had a minimum of three years of post-qualification clinical experience. The acupuncturists were encouraged by the researchers to provide their typical treatment so that the study would evaluate the effect of routine care for lower back pain, each acupuncturist making meticulous notes of the aspects…… [Read More]
The authors state: "The amphetamines occasioned dose-related increases in d- amphetamine-appropriate responding, whereas hydromorphone did not. Amphetamines also occasioned dose-related increases in reports of the drug being most like "speed," whereas hydromorphone did not. However, both amphetamines and hydromorphone occasioned dose-related increases in reports of drug liking and in three scales of the ARCI. Thus, some self-report measures were well correlated with responding on the drug-appropriate lever and some were not. Lamb and Henningfield (1994) suggest that self-reports are complexly controlled by both the private event and the subject's history of experience with the drug. Some of the self-reports they observed (e.g., feels like speed) are probably occasioned by a relatively narrow range of stimuli because in the subject's experience with drug administration, these reports have been more selectively reinforced by the verbal community relative to other reports (e.g., drug liking). They also suggest that these results imply…… [Read More]
Efficacy and Safety of Dabigatran vs. Warfarin for Stroke
After more than five decades as the preferred anticoagulant worldwide, warfarin is being challenged by a new rival that doesn't require careful dosage monitoring. Pradaxa (dabigatran) was unanimously approved by the FDA on October 19, 2010 for treating atrial fibrillation (AF) patients, who are at an increased risk for suffering stroke and systemic embolisms (.S. Food and Drug Administration). Dabigatran acts by binding directly to thrombin. Warfarin (Coumadin) is an anticoagulant that functions by inhibiting the synthesis of vitamin K-dependent clotting factors (Lemos et al., 770-771). Variations in the levels of vitamin K in the diet can influence how effective a given dose of warfarin is for a patient, so appropriate therapeutic dosages are determined on an individual basis periodically through a standardized clotting test (international normalized ratio [INR]). Even though warfarin can reduce the risk of stroke in AF patients…… [Read More]
The author of this report has been to assess a data flow diagram that makes reference to clinical trials. For each step in the clinical trial, the author of this response will speak to what personnel would be involved with that step of the process. Indeed, the data flow diagram in question is seventeen steps long and the litany of personnel involved with each step can be moderate to extensive. While some may think that clinical trials are fairly mundane and easy to pull off, that is simply not the case and the process is indeed extensive and potentially circuitous depending on how things go (FDA, 2016).
Step one of the diagram involves protocol development. The personnel involved would include medical writers, physicians, medical experts, project managers, biostatisticians and data managers. The protocols and rules of the study are important and must be defined. Step two…… [Read More]
(NHS Institute for Innovation and Improvement, 2008)
The Angiotensin-converting enzyme inhibitors are stated to be "recommended as first-line treatment in all people with left ventricular systolic dysfunction (LVSD) "with or without symptoms of heart failure." (NHS Institute for Innovation and Improvement, 2008) Additionally it is stated that strong evidence exists that ACE inhibitors "...increase life expectancy in people with LVSD and reduce the risk of hospitalization -- the effect is greatest in those with more severe LVSD or more severe symptoms, but benefit occurs for all degrees of severity." (NHS Institute for Innovation and Improvement, 2008)
Prescribed for individuals who are intolerant of ACE inhibitors due to cough are
Angiotensin-II receptor antagonists which provide an alternative to angiotensin converting enzyme (ACE) inhibitors." (NHS Institute for Innovation and Improvement, 2008) There is stated to be evidence that AIIRAs supports life expectancy improvement and symptoms for those with heart failure due to…… [Read More]
Participants filled out a Short-Form McGill Questionnaire, an Arthritis Self-Efficacy Scale, and Fibromyalgia Impact Questionnaire in order to measure their levels of pain over the past few weeks. What the researchers found through statistical analysis was self-management strategies that reduced pain over time were most effective in the group that was exposed to guided imagery techniques. The level of guided imagery therapy was not itself significant, but more of the fact of whether or not it was present in the patient's therapy or not. This helps illustrate the effectiveness of guided imagery in managing long-term chronic pain when there are no fundamental cures present within traditional therapeutic practices. Pain management symptoms improved, but the symptoms overall remained. This shows that guided imagery is not a cure in and of itself, but rather an effective way to reduce and manage the pain that is present in chronic conditions like fibromyalgia.
Weydert,…… [Read More]
Webster et al. 2007) is effective because it clearly identifies the purpose and nature of the study in the trial itself. The CONSOT criteria specifically state that the randomized nature of the trial must be indicated in the title, which is evident in the case of the present study. andomized trials are necessary for health care studies because they help to maintain the homogeneity of the samples (Jadad & Enkin, 2007). It also eliminates selection bias (Piantadosi, 2005). Hence, it may be said that the title is effective because it states that the study was based on a randomized trial.
It is necessary for an effective abstract to have a structured summary of the research design, methods, results, and conclusion. The abstract provides a concise, clear and well-structured summary for the reader. The information has been organized separately to facilitate comprehension. The abstract describes the background, objective, design, setting, participants,…… [Read More]
Thoracic Manipulation on Patients with Chronic Mechanical Neck Pain: A andomized Controlled Trial
The objective of this work in writing is to critique the study reported in the work of Lau, Chiu, and Lam (2011) entitled "The Effectiveness of Thoracic Manipulation on Patients with Chronic Mechanical neck pain -- A andomized Controlled Trial" reported in the Journal of Manual Therapy.
The aim of the study reported by Lau, Chiu, and Lam is stated to be assessment of the effectiveness of "thoracic manipulation (TM) on patients with chronic neck pain." (2011, p.141) Lifetime prevalence of neck pain is stated at 66.7% and 12-month prevalence at 53.6%. (Lau, Chiu, and Lam, 2011, p.141) Neck pain is expensive to treat in addition to the suffering of the individual and lost work time due to employee absenteeism. (Lau, Chiu, and Lam, 2011, paraphrased)
There is growing evidence, which has demonstrated that manipulation with exercise…… [Read More]