What is a research study?

A research study or clinical trial is a carefully designed study aimed at gathering important data regarding the safety and efficacy of a new or established treatment or treatment method for human use. Through rigorous testing, statistical evidence is gathered to assess the treatment's safety and effectiveness. To guarantee ethical treatment of participants and ensure their informed consent, all clinical trials are legally mandated to undergo thorough review, approval, and monitoring by an Institutional Review Board (IRB). This process ensures that participants are fully informed about the study before deciding to participate.

How does a research study work?

During a research study, participants are typically assigned to specific study groups. Within these groups, some volunteers may be given an investigational treatment or study drug, while others may receive a placebo or a treatment that is already available.

A placebo is an inert substance used to evaluate the effectiveness of the experimental treatment. To ensure objectivity, neither the participant, the physician, nor the research staff are aware of who is receiving the placebo and who is receiving the active treatment. This allows the physician and research staff to impartially observe the participants throughout the study. Regardless of the treatment received, every participant is provided with equal medical attention and respect.

Who can take part in a research study?

Each study has distinct eligibility criteria that pertain to the type of participants required for the study. These criteria serve the purpose of collecting reliable statistical data to fulfill the study's objectives effectively. Furthermore, special populations, such as children/minors, pregnant women, indigents, prisoners, and other vulnerable groups, require additional safety measures and ethical oversight to prevent any potential risks or undue influence on study volunteers.

Why does society need clinical trials?

Clinical trials play an indispensable role in the existence of the medications and treatments available today. Through rigorous testing, the development of new treatments that are both safe and effective becomes possible. The Food and Drug Administration (FDA) mandates thorough testing of all medical treatments or methods to ensure their effectiveness and overall safety. Volunteers who participate in clinical trials offer a valuable service to the community by aiding researchers in advancing medical science and enhancing healthcare for future generations.