In Celebration of Heroes: International Clinical Trials Day

If there is a silver lining during the COVID-19 pandemic, it is the hopeful headlines about the heroes in our midst, the first responders and essential workers who risk their lives daily for the greater good. I know a little something about heroes. For the better part of 20 years, I have been a clinical researcher. And it never ceases to amaze me how selfless patients with life-threatening diseases who participate in clinical trials can be.

Since 2005, May 20 is globally recognized as Clinical Trials Day. The day commemorates May 20, 1747, the start of the first clinical trial in history. Surgeon James Lind was working on a British Royal Navy ship, the HMS Salisbury. Scurvy, a nutritional disease caused by a vitamin C deficiency, was common among sailors and often deadly. Lind gathered 12 men and gave citrus fruits to some and not to others, to determine if the vitamin C in citrus could cure scurvy. Today, vitamin C supplements are indeed used to cure the disease.

Lind’s clinical trial laid the foundation for modern clinical research. As of May 18, ClinicalTrials.gov listed 339,408 registered studies in 213 countries. Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Investigational treatments must be studied in laboratory environments first to determine potential toxicity before they can be tried in people.

Disease is an unwelcome guest, but it can bring out the best in us. I have been inspired by cancer clinical trial patients who are grateful for the extra time an investigational therapy afforded them -- time to watch their children grow and time to attend family events, like graduations and weddings. And I have been humbled by patients who volunteer for trials, such as early-phase studies, without any guarantees, except for the knowledge that they may help someone else in the future.

Clinical Trials Day seeks to raise clinical trial awareness and honor patient volunteers and clinical research professionals around the world for their contributions to medicine and public health. Research is a process -- of trial and error, watchful waiting and sometimes, breakthroughs. It requires perseverance and patience and is fed by dedication and the desire to solve a puzzle, right a wrong and make a difference. Research is a calling.

As the world today tries to function via social distancing, clinical trials -- from registration to implementation -- are particularly hard pressed. Travel and social restrictions present challenges in diagnosis, drug administration and patient monitoring, including bloodwork and other tests. Patient and study site flexibility and telehealth are making up for some of the shortcomings, but it is clear that we need new guidance on how to proceed now and in the near future.

It is also clear that to be successful, clinical trials require two things: researchers who keep looking for solutions to the world’s health threats while “doing no harm;” and patients who keep volunteering for clinical trials, for the sake of “doing some good” for themselves and others. To my fellow researchers and all patient volunteers, now and in the future, I wish you a Happy Clinical Trials Day and express my deepest admiration and appreciation.