Clinical Protocol Differences
The author of this response is asked to do a few things from a research standpoint. After which, the author shall answer a question related to the activities completed. First, the author of this response is to conduct a literature review about the protocols and methods used to develop a new drug and get it approved by the Food and Drug Administration and other relevant regulatory bodies. Second, the author is asked to a similar review but one that pertains to studies and research that is simply meant to add to the knowledge base that exists in the medical and clinical sphere. The author must then consider the differences and similarities between the two and summarize that in the form of the author's discussion response.
Both knowledgebase studies and drug approval processes have one major similarity and that is to advance the field of medical science. The field is all about saving lives, prolonging lives and helping everyone around the world in terms of medical care and quality of life....
However, there is one stark difference between knowledgebase studies and those that pertain to drugs. When it comes to drugs and their approval, people will be taking those drugs. Drugs potentially come with nasty side effects and some people can even die when taking the wrong drug or the wrong combination of drugs. When it comes to knowledgebase articles, the stakes are rarely that high.
For example, if drug A is being considered for approval, there are extensive tests and trials. Those tests are done to ensure and verify whether the drug treats the diseases and/or disorders that it is meant to treat. At the same time, it has be verified whether there are any health risks involved. Anyone who has read the potential or likely side effect list for a drug knows those lists can be very extensive. Even approved and commonly used drugs come with major warnings and/or restrictions and the perceived or actual effects of taking those drugs are often fodder for trial lawyers that only see dollar signs (Berenson, 2003).
By contrast, knowledgebase articles are typically more benign. For sure, they could pertain to drugs and their effects but they are typically drugs that are already approved and commonly used. Other knowledgebase article relate to things that are somewhat removed from the medical care itself including the knowledge, perception and feelings of…
FDA Drug Approval Process In order for a pharmaceutical company to obtain FDA approval for a new drug, a long sequence of detailed testing and clinical trials must be administered. The approximate cost of putting a new drug through the approval is $500 million, and it takes an average of fifteen years for a drug to make it from initial testing to being available for patients. Furthermore, of every 5000 compounds
Patient and family education is essential especially with regards to eating habits. The patients should avoid excess fat in their diet as it contributes to high chances of contracting the disease (Bolen et al. 2010). The drug has, however, remained on the market in the U.S. The drug has been removed from European markets due to escalating concerns regarding safety. Obesity has considerable contribution to the number of preventable deaths
Phase II consists of efficacy trials of the drug, which are tested on volunteers of the target population. When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for phase III with the FDA. Phase III is the more extensive. It is at this time that the manufacture can work for the accelerated development and review of the drug. Treatment IND
It so happened that Russian doctor Karlov was trying to find patients for another clinical trial for an experimental drug, and Ershov fit the requirements to enter the study. "They told me the treatment was safe," says Ershov. "I trust my doctor completely." Like 90% of Karlov's other clinical-trial patients, he immediately signed the consent form (Lustgarten, p. 1). Russia is one of those countries that suffers from high
Medical devices: FDA should take steps to ensure that high -Risk device types are approved through the most stringent premarket review process. Medical Device Reporting (MDR) Medical Device Reporting (MDR) is the name of the Act that allocates control to the Food and Drug Administration to monitor results of medical devices in order to make sure that no adverse effects results to society. The FDA receives information on this account from all
Future Regulatory Improvements (FDA) The Prescription Drug User Fee Act allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. The new drug approval process is costly for both drug companies and for the FDA. The latter is funded primarily through the federal government, so this law allowed the FDA to be more self-funded. Theoretically, this would also allow it to charge fees that reflected