Why Clinical Trials Matter

Why Clinical Trials Matter

Health and Fitness June 13, 2017

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Being part of a clinical drug development trial is an opportunity to help researchers tackle health issues and bring medication to market that can improve and even save the lives of suffering from a disease. Signing up to be part of such a clinical study can be daunting, though, if you do not know what to expect and how the process will work.

The Federal Drug Administration (FDA) sets out the process for clinical drug development. Such medical research studies are conducted in phases and the processes differ slightly depending on the phase of the trial. All drugs for human use are tested extensively to determine things such as side effects, toxicity levels, contraindications and how such drugs react in people of different ages, races or genders.

Human testing in clinical trials is governed by a strict code of ethics that requires that participants give what is called informed consent. This means that the participant is fully informed about the risks and potential dangers of participating in a clinical trial, understands what will be done to him or her and what the possible outcomes are and willingly — without coercion — agrees to take part in the clinical study.

In some cases researchers will need to test children — defined in this case as any person under the age of 18 — and will therefore need to obtain consent from the child’s parent or guardian. This is a legal requirement and researchers must ensure that this is done.

Depending on the phase of the trial, the size of the sample of participants will differ. A group of between 20 and 80 is used in phase 1 clinical trials, while Phase 2 trials involve groups between 100 and 300. Between 1,000 and 3,000 people are recruited for Phase 3 clinical trials. Each phase is designed to test for different things, so Phase 1 trials examine the safety of a drug and look at potential side effects, while the focus of Phase 2 trials is on the effectiveness of the drug and Phase 3 is more all encompassing, used to assess and monitor side effects and effectiveness in comparison with other treatments.

The final phase is Phase 4, which is the point at which the medical research study team actually asks for approval to put the new drug on the market through the submission of a New Drug Application (NDA). Obtaining that approval is not easy with just 5% (250) of the 5,000 to10,000 drugs undergo the research and development process every year actually making it to to pre-clinical trial testing. Just five of those go on to clinical trial testing and in the end a single one actually passes FDA approval.

The importance of clinical trials is indisputable and yet the majority of the population (96%) have not participated is such a study, according to a research U.S survey. This is despite the fact that just under half of respondents rated clinical trials as as important as giving blood. Understanding the process of clinical drug development might make signing up less daunting and increase the number of people contributing to this important part of the medical field.