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 will be necessary…...
mla
References
Petryna R. (2007). Clinical Trials Offshored: On Private Sector Science and Public Health. BioSocieties 2:21-40.
Rettig, R. (2000). The industrialization of clinical research. Health Affairs 19(2): 129-46.
Shuchman, M. (2007). Commercializing Clinical Trials -- Risks and Benefits of the CRO Boom. New England Journal of Medicine 357: 1365-8.
Sen, F. & Shiel, M. (2006). From business process outsourcing (BPO) to knowledge process outsourcing (KPO): Some issues. Human Systems Management25(2): 145-55.
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.
Does the report…...
mla
References
Bandura A. (1986). Social foundations of thought and action: A social cognitive theory.
Englewood Cliffs, NJ: Prentice-Hall.
Walker SN, Pullen CH, & Boeckner L, et al. (2009) "Clinical trial of tailored activity and eating newsletters with older rural women." Nurs Res. 2009 Mar-Apr;58(2):74-85. Retrieved
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…...
mla
References
Kermani, Faiz. (2010, January 12). Difficult issues in pharma going global. Pharma Phorum.
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…...
mla
References
What are clinical trial phases? (2006, October 11). FAQ: Clinical Trials. National Institute of Health (NIH). Retrieved November 17, 2001 at http://www.nlm.nih.gov/services/ctphases.html
What is a clinical trial? (2006, October 11). FAQ: Clinical Trials. National Institute of Health
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 research.…...
mla
References
Krishnankutty, B., Bellary, S., Kumar, N. B. R., & Moodahadu, L. S. (2012). Data management in clinical research: An overview. Indian Journal of Pharmacology, 44(2), 168-172. http://doi.org/10.4103/0253-7613.93842
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 improving the quality…...
mla
References
Doll, K.M., Kalinowski, A.K., Snavely, A.C., Irwin, D.E., Bensen, J.T., Bae-Jump, V.L. et al. (2014). Obesity is associated with worse quality of life in women with gynecologic malignancies: An opportunity to improve patient-centered outcomes. Cancer, published online ahead of print 23 Sep. 2014. Doi: 10.1002/cncr.29061.
Glaser, V. (2007, May 1). Building better pipelines withy ADME-Tox: Advances in microdosing, in vitro analysis, and biosimulation for optimized predictive studies. Genetic Engineering & Biotechnology News, 27(9).
Efficacy of Adrenaline in Out-of-Hospital Cardiac Arrest
Levels of evidence
Audience
Search Strategy
Inclusion Criteria
Exclusion Criteria
Prior esearch
Issues with Prior Studies
Efficacy of Adrenaline in Out-of-hospital Cardiac Arrest
Levels of evidence
Observational studies
andomized control trials
andomized clinical blinded trial
etrospective studies
Audience
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.
Search Strategy
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" to retrieve relevant literature.
Inclusion Criteria
In this study, the identified studies were those of empirical studies. Even though…...
mla
References
1. Mehra R. Global public health problem of sudden cardiac death. J Electrocardiol 2007;40:S118 -- 22
2. Ristagno G, Sun S, Tang W, Castillo C, Weil MH. Effects of epinephrine and vasopressin on cerebral microcirculatory flows during and after cardiopulmonary resuscitation. Crit Care Med 2007; 35: 2145 -- 2149.
3. Wang HE, Min A, Hostler D, Chang CC, Callaway CW. Differential effects of out-of-hospital interventions on short- and long-term survival after cardiopulmonary arrest. Resuscitation 2005; 67: 69 -- 74.
4. Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, Miyazaki S. Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest. J Am Med Assoc 2012; 307: 1161 -- 1168.
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 regularly…...
mla
References
Krishnankutty, B., Bellary, S., Kumar, N. B. R., & Moodahadu, L. S. (2012). Data management in clinical research: An overview. Indian Journal of Pharmacology, 44(2), 168-172. doi. 10.4103/0253-7613.93842
Tang, P., Overhage, J., Chan, A., Brown, N., Aghighi, B., & Entwistle, M. et al. (2013). Online disease management of diabetes: Engaging and Motivating Patients Online with Enhanced Resources-Diabetes (EMPOWER-D), a randomized controlled trial. Journal of The American Medical Informatics Association, 20(3), 526-534. http://dx.doi.org/10.1136/amiajnl-2012-001263
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 and enforcement of…...
Bio-Statistics
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 is…...
mla
References
Ferguson, Geroge A. 1966. Statistical Analysis in Psychology and Education. New York:
McGraw-Hill Book Company
Ohlson, E.L 1998. Best-Fit Statistical Procedures, ACTS Testing Labs. Chicago Thompson, David M., Kozak, Sharon E. And Sheps, Sam (1999). Insulin adjustment by a diabetes nurse educator improves glucose control in insulin-requiring diabetic patients: A randomized trial. CMAJ, 161(8):959-62
Van Dalen, Debold B. (1966). Understanding educational research. New York: McGraw-Hill
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.
Literature eview
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 (AACN), held an extraordinary…...
mla
References
Dalton, B., & Wright, L. (1999). Using Community Input for the Curriculum Review Process. Journal of Social Work Education, 35(2), 275.
Feldman, H.R. & Greenberg, M.J. (Eds.). (2005). Educating Nurses for Leadership. New York: Springer.
Kennedy, M.S.. (2004) Introducing the Clinical Nurse Leader. American Journal of Nursing, 104 (10), 22.
Knorr, R.S., Condon, S.K., Dwyer, F.M., & Hoffman, D.F. (2004). Tracking Pediatric Asthma: The Massachusetts Experience Using School Health Records. Environmental Health Perspectives, 112(14), 1424-1439.
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, Clinical esearch…...
mla
References
Krishnankutty et al. (2012, March-April). Data Management in Clinical Research: An Overview. Indian Journal of Pharmacology, 44(2), 168-172.
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,…...
Weisfeld, N., English, R. A., & Claiborne, A. B. (Eds.). (2012). Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. National Academies Press.
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, 2007). As…...
mla
References
Glancszpigel, D. & Racaro, G. (2007, November). Create a successful project plan for global trials. Applied Clinical Trials, 52-54.
Metzl, J. M. & Kirkland, A. (2010). Against health: How health became the new morality. New York: New York University Press.
Rodwin, M. A. (2011). Conflicts of interest and the future of medicine: The United States, France, and Japan. New York: Oxford University Press.
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…...
mla
References
Constanta, R. (2008). An integrative approach to quality of life management. Sapient 1(1), 12-16.
Muller, Hans-Jurgen. (2011). Effectiveness studies: Advantages and disadvantages. Dialogues on Clinical Neuroscience, 13(1), 199-207.
Lewis, John A. (2002). Study designs, duration, and choice of comparators including the use of placebo. Dialogues in Clinical Neuroscience, 4(4), 463-469.
Depression is less prevalent in communities that naturally consume significant amounts of omega 3 fatty acids in their diets. Omega 3 fatty acids naturally occur in fish, which has led to the belief that fish oils may help prevent or treat depression and other mood disorders. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are believed to help with mood disorders, though the method of interaction is not fully understood. The theory is that they are anti-inflammatory, and they interact with mood molecules. Clinical trials examining omega-3 therapy as a stand alone and as an add-on therapy support its use to....
1. The Role of Exercise in Preventing Cardiovascular Disease in Men: A Comprehensive Examination
Introduction: Highlight the prevalence and impact of cardiovascular disease (CVD) among men and emphasize the role of exercise as a preventive measure.
Body: Discuss the physiological mechanisms by which exercise improves cardiovascular health, including increased blood flow, improved blood pressure regulation, and enhanced lipid profiles. Explore the specific types and intensities of exercise that are most effective in reducing CVD risk. Review evidence from clinical trials and observational studies demonstrating the association between regular exercise and lower incidence of CVD events.
Conclusion: Summarize the key findings supporting the protective....
1. The Impact of Substance Abuse on Families and Communities
Substance abuse has far-reaching consequences that extend beyond the individual abuser. It can have a devastating impact on families and communities, leading to a range of social, economic, and health problems. This essay topic explores the ways in which substance abuse affects families and communities, including the increased risk of domestic violence, child abuse, and neglect, as well as the financial burden of substance abuse treatment and the strain on community resources. It also examines the role of nurses in addressing the impact of substance abuse on families and communities, through....
Of course! Here are some potential essay topics related to the placebo effect that you could consider:
1. The history and origins of the placebo effect: Exploring how the concept of the placebo effect has evolved over time and its cultural and scientific roots.
2. The psychology of the placebo effect: Analyzing the psychological mechanisms behind the placebo effect and how factors such as expectation, conditioning, and belief play a role.
3. The ethics of placebo treatments: Discussing the ethical implications of using placebos in medical practice and research, including issues of informed consent and deception.
4. The neurological basis of the placebo effect:....
Sign Up for Unlimited Study Help
Our semester plans gives you unlimited, unrestricted access to our entire library
of resources —writing tools, guides, example essays, tutorials, class notes, and more.
