Article originally published on LinkedIn August 6, 2018.
The path to getting drugs on the market is a long and arduous one filled with lots of twists and turns unknown to majority of people. When compounds are identified as having the potential to curb disease, they are put through the ringer to ensure both effectiveness and safety. The last thing anyone needs is to be exposed to a drug that will cause more problems.
The need to get drugs on the market as quickly as possible is understandable. Yet, the costly development, compounded with the high probability of drugs failing the clinical trial process (1) affect not only the rate at which drugs make it to pharmacy shelves, but also the cost of those drugs that actually do make it to market........ So let me break this down.
Pre-clinical studies begin after potential drugs have been identified. We (scientists and drug makers) check to see several things such as what the compound targets, the mechanism it uses, the different pathways it affects, and its toxicity within cells. Next, we carry out similar tests in different animal models because the way a compound generally works in a petri dish (in-vitro) is quite different from the way it performs within an organism (in-vivo).
Upon analysis of the results, if favorable, we reach out to the FDA saying there is a potential drug and we would like to further investigate it by completing an Investigational New Drug (IND) application. If approved, the process moves into a small group of healthy individuals (Phase I) to determine possible side effects of different doses of the drug. Phase II involves a slightly larger group of individuals who are affected by the disease the drug is expected to treat. During this phase, the efficacy of the drug is compared against a dummy drug (a placebo). The move to Phase III includes an even larger group of individuals and evaluates the effectiveness of the new drug against pre-existing drugs (if there are any).
Remember: each phase has its own checkpoint that allows a potential drug proceed forward or stops its testing altogether.
Based on the results of the phase III trial, an approval of the new drug to the public is requested from by filing a New Drug Application (NDA) with the FDA. The processes of monitoring and evaluations continue even after the drug has been released to the general public. Click here to know more.
The success of developing drugs is incredibly dependent on access to volunteers. Volunteers provide substantial data needed to make informed decisions about a drug’s effectiveness and safety (2). Retention of volunteers during a study is of great importance. Often volunteers dropout of a clinical study for various reasons.
I strongly believe that increasing the inclusion criteria, explaining the importance of volunteer participation and reducing the complexity and burden of the study protocol will allow for a better patient retention rate.
Looking to volunteer, lists of clinical trials are available here.
All thoughts, comments and suggestions are very much welcome :)
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