Clinical trials represent an integral part of healthcare. Seladi-Schulman (2018) acknowledges the importance of clinical trials in testing new methods of diagnosing, treating, and preventing certain health conditions. The United States Food and Drug Administration (2018) lists five phases that are involved in clinical trials. The first phase is called discovery and development. It entails getting new insights into a disease process, which allows researchers to conduct experiments to gather more information about it. At this stage, a handful of subjects may be used to test on the metabolism of the drug (Cancerresearchuk.org, 2019).
The next phase is preclinical research. This is where researchers conduct experiments to find out whether the drug has the potential to harm humans. This is often done before human subjects can be used for testing. After the step mentioned above, clinical research proceeds, which involves dosing living human beings to assess the potency of a given drug. It is at this phase whereby the researchers have the option of using a control group or not. This phase is extremely crucial as the data obtained here will be used to formulate the doses if the drug is approved.
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Once the clinical research is exhausted, the researchers then make a formal application to the FDA for its review and approval. Data from both the preclinical and clinical trials are vital for the decision of the FDA. If the drug meets all the safety regulations, it is approved and released into the market for sale. The final step involves post-market safety monitoring. This step serves to complement the clinical phase by reviewing reports from a larger uncontrolled population. Cautions to the dosage can then be added depending on the feedback.
Drug development is not without its controversies. Controversies associated with clinical trials often arise at the clinical research phase, where humans are introduced as test subjects. With no prior knowledge of the drug, a lot can go wrong at this stage. Caffrey (2016), a BBC reporter, published the story of Rob Oldfield, who signed up for the clinical trial but ended up fighting for his life. The drug in the discussion was meant to revolutionize the treatment of leukemia but ended up seriously affecting the participants’ immune system. It is cases like these that delay the development of new drugs. However, safety should always come first in every experiment, and luckily, regulatory bodies like the FDA are there to ensure this conformance.
References
Caffrey, J. (2016, March 19). 'I nearly died in a medical drug trial' . Retrieved from https://www.bbc.com/news/magazine-35766627 .
Cancerresearchuk.org. (2019, February 13). Phases of clinical trials . Retrieved from https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials- are/phases-of-clinical-trials .
Seladi-Schulman, J. (2018). What happens in a clinical trial? Retrieved from https://www.healthline.com/health/clinical-trial-phases
The U.S. Food and Drug Administration. (2018). The drug development process . Retrieved from https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development- process .
