Clinical Trials Day: The Enduring Value of Clinical Trials Research
Clinical Trials Day is May 20!
Every year on May 20, the scientific and medical research community marks Clinical Trials Day. Organized since 2014 by the Association of Clinical Research Professionals, this day commemorates the contributions of participants and researchers to the field of clinical trial research. Clinical Trials Day also specifically marks the anniversary of the first randomized clinical trial, which was conducted by James Lind aboard the HMS Salisbury in 1747 and which entailed a study of treatments for the disease of scurvy among Scottish sailors. This 1747 clinical trial most notably produced evidence of the benefits of citrus fruits in treating and preventing the disease.
Clinical trials are a critical part of developing treatments for illnesses and diseases, serving as a means of generating evidence to support the regulatory decision-making for safe and effective new medicines. Clinical trials proceed in three phases. Phase 1 includes a small number of subjects, ranging from a few dozen to fewer than 100. (Fun fact: James Land’s original clinical trial involved only 12 sailors on the HMS Salisbury!) If the results in Phase 1 justify additional research, then Phase 2 trials involve several hundred subjects. If the results in Phase 2 similarly warrant further research efforts, Phase 3 trials involve several thousand subjects. If a treatment is determined to be safe and effective after Phase 3 trials, the FDA issues approval for the use of the treatment for appropriate people in the population at large.
Within the Food and Drug Administration (FDA)’s Center for Drug Evaluation Research (CDER), there exists a Center for Clinical Trial Innovation (C3TI). C3TI serves as a hub aimed at improving the efficiency of drug development through innovative approaches to clinical trials. C3TI promotes innovation by:
Advancing knowledge sharing through public workshops, forums, outreach, and the C3TI knowledge repository.
Facilitating collaboration across CDER’s innovation programs.
Managing a Demonstration Program to test and scale innovative approaches to clinical trials and expand opportunities for engagement between drug developers and CDER staff.
Serving as a central point of contact for non-product-specific questions related to clinical trial innovation.
Interested individuals may sign up to receive the C3TI Newsletter at the following link: What’s New in Clinical Trial Innovation | FDA. This newsletter contains information on new developments, opportunities, and initiatives in clinical trial innovation.
Clinical trial research is a critically important effort to advancing scientific and medical research, combating illnesses, and improving quality of life in communities across the world.
If you are interested in becoming a clinical trial participant, please take a look at the following website: Finding a Clinical Trial | National Institutes of Health (NIH). The website provides resources for individuals looking for clinical trials, and includes a link to www.clinicaltrials.gov, which offers the opportunity to search for clinical trials by criteria including specific condition, type of treatment, and geographical location.
You can also visit our open trials page to see what is currently available or sign up for future studies that might be of interest in you.