Module 04 Course Project - Writing Compliance Procedures

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Monitoring and Regulating Clinical Trials

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Monitoring and Regulating Clinical Trials

In the process of the development of drugs and devices that ought to be used by human beings, researchers are required to conduct clinical trials. Clinical trials help to provide evidence concerning particular treatment, establish or compare the effectiveness of the new drug with existing medication or measure responsiveness of human beings that have been assigned with health-related biomedical. Clinical trials are conducted on people that have volunteered. However, before conducting a clinical trial, approval must be sought from FDA and be administered to volunteers that meet inclusion or eligibility test.

The researcher or institution that is conducting the clinical trial, is required to inform participants of potential risks attached to the exercise. Additionally, body administering should also explain safeguards that have been put in the place to counter possible unexpected outcomes or responses from the human body. All the clinical trials which involve human beings must be registered and approved by the U.S FDA. Additionally, Institution Review Board is established which reviews, monitors and approves biomedical research. Before approving clinical, IRB ensures that participant protection is assured and one of the ingredients checked is informed consent. Therefore, considering the case presented in the text where the placebo is administered without the knowledge of the participants, the clinical trial is in breach of informed consent and could not be approved by FDA.

It is the sole duty of the FDA to ensure the safety, efficacy and security of human and veterinary drugs, medical devices and biological products (Fleming, Demets & McShane, 2017). Even though clinical trials are important in the search for medical knowledge and treatment, the safety of human beings and the efficacy of biomedical products in the discovery process are of great concern.

Currently, pharmaceuticals are in the search for the COVID-19 vaccines. FDA has approved Pfizer and Moderna COVID vaccines (Tanne, 2020). FDA reported that clinical trials from two vaccines have shown the efficacy of more than 95%. Ideally, before two vaccines were allowed to be produced for distribution, FDA had issued approval for clinical trials and closely monitored to ensure policies and regulations that govern how clinical trials are conducted were adhered to. Further, FDA reviewed preliminary results from the clinical trials and assessing the efficacy rate of two vaccines before issuing emergency authorization for production and distribution.

References

DrugWatch. (n.d). FDA Clinical Trials. Retrieved from https://www.drugwatch.com/fda/clinical-trials/

Fleming, T. R., Demets, D. L., & McShane, L. M. (2017). Discussion: The role, position, and function of the FDA-The past, present, and future. Biostatistics (Oxford, England), 18(3), 417–421. https://doi.org/10.1093/biostatistics/kxx023

Tanne, J. H. (2020). Covid-19: FDA approves Moderna vaccine as US starts vaccinating health workers. BMJ: British Medical Journal (Online), 371.