Clinical Trial Participation: What You Need to Know

Have you ever wondered how a drug is discovered and developed? While the process takes more than 10 years to complete, the entire development is stringently regulated for safety and effectiveness by drug regulatory authorities such as FDA. Right from the preliminary step to the final step of releasing the medicine into markets, the drug undergoes rigorous research processes to ensure that it is safe for treatment. Based on international guidelines, a molecule identified for research study in human participants must have a clear scientific purpose, along with benefits that supersede any potential side effects. Having stated that, it is essential that the molecule must have already been tested on animals in a laboratory for ensuring safety in human subjects. These are called pre-clinical studies or animal studies, and the outcomes of this research serve as the basis of human clinical trials.

Clinical Trials in Humans

After conducting animal studies, the results are submitted to regulatory bodies and Institutional Review Board (IRB: a diverse board of members with legal, medical, or government professionals) for approval to begin a Human Clinical Trial. All the information on drug’s chemical profile, its dose and formulation, and the test results of preclinical studies are submitted for review. Once approved, enrollment of human subjects (participants) is initiated.

The recruitment of volunteers is usually done by clinical research organizations or research companies, by advertising their clinical trial through different mediums in order to attract volunteers who might be interested in participation. Persons who are interested in participating may contact the organization conducting the trial for more information to learn in detail about the process, requirements, medical care, and compensation. As soon as the participant expresses interest, uninfluenced, voluntary informed consent is obtained before the start of medical screening. At this stage, every individual is assessed and screened medically to confirm if they are fit to take part in the trial.

There are certain criteria that researchers may stick to when assessing a participant for a clinical trial; these criteria are called inclusion/exclusion criteria, and these often align with the purpose of the clinical trial. For example, a specific study for weight loss may require someone who has a BMI score of 27 and above to study the potential effectiveness of the drug than someone who has 25. On satisfying all the criteria required for study enrollment, the trial begins, and the participants are tested with the study drug as per the schedule designed for their study. After the trial drug is given to them, they are observed carefully through specific laboratory parameters, test results, and vital signs, for treatment effectiveness or any side effects that may arise due to the drug. All these observations are recorded timely and accurately by the research team in order to infer the results at the end of the trial.

Informed Consent

As mentioned earlier, all aspects of the trial must be clearly and adequately explained to study participants, giving them enough time to reflect on and make an informed decision. The main goal of the IRB and regulatory bodies is to ensure that the trial participants are respectfully, ethically and safely enrolled in the study without compromising their rights or well-being. It is a fundamental requirement that any research organization needs to fulfil, or they may face legal penalties or consequences for violating human rights and ethics. Also, vulnerable participants such as prisoners, children, or mentally compromised should not be exploited to unlawfully conduct studies, unless in cases where there is a need to cure them or treat them in terminal illnesses where no other treatment may be available to save their life.

In case of treating children or vulnerable populations, research may be conducted only when there is direct benefit to them and when a family member or guardian can officially provide legal consent on their behalf. From a legal perspective, no participant should be forced, persuaded, or influenced to participate in a clinical trial without voluntary consent. All questions regarding the trial including medical care coverage, treatments, procedures, and compensation must be clearly and elaborately answered before requesting the participant for voluntary consent.

Participant Rights

As a participant, every individual has the right to protect their own well-being and rights while contributing to the process of drug development. Conducting clinical trials in compliance with laws and regulations to protect participants is inevitable for any research company or organization. As a study participant, one has the right to collect information about trial duration, new risks emerging during trials, medical care, financial compensation, and personal data utilization. Although all clinical studies mostly require informed consent before proceeding, some trials may be allowed to conduct a study without requiring informed consent when there is no or minimal risk to the participant. This usually applies to studies where personal data or an individual’s health information remains unidentifiable. So, before enrolling in a study, it is always advisable to collect as much information as possible and to give enough time to yourself in order to make a well thought out decision.

References

1.       346. Consent and Early Withdrawal or Cessation of Participation | Research Integrity & Security. (n.d.). University of Nevada, Reno. https://www.unr.edu/research-integrity/program-areas/human-research/human-research-protection-policy-manual/346-consent-and-early-withdrawal-or-cessation-of-participation

2.       Meason. (2026, January 30). Drug Discovery and Development Process | PPD. https://www.ppd.com/what-is-a-cro/drug-discovery-and-development/

3.       Underhill, K. (2014). Legal and ethical values in the Resolution of Research-Related Disputes: How can IRBs respond to participant complaints? Journal of Empirical Research on Human Research Ethics, 9(1), 71–82. https://doi.org/10.1525/jer.2014.9.1.71

4.       Your rights as a participant in a research study or clinical trial. (n.d.). Your Rights as a Participant in a Research Study or Clinical Trial. https://www.facingourrisk.org/research-clinical-trials/why-enroll/your-rights-as-a-participant

Assessed and Endorsed by the MedReport Medical Review Board