FDA Drug Review Process

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. Summary 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 patients and practitioners.

Other times, the knowledgebase studies are assessing negative events like medical malpractice, adverse events and unexpected patient deaths. While those are surely tragic and the people directly involved are susceptible to investigation and regulation, the knowledgebase researchers that assess theses happenstances after the fact are in no such position. That being said, people engaging in knowledgebase articles and studies have strict standards they need to follow. Quite often, knowledgebase articles are shared with others via a peer-review process so as to verify the validity and reliability of the research findings.

It is not as if these knowledgebase people can just print anything they think is true. There has to.