The Significant Contribution of Clinical Trials in Bringing The Very Latest Healthcare Treatments to Humanity
The global pandemic has brought medical research into the spotlight. “Clinical Trials”, “Safety”, “Pharmacovigilance” and “Epidemiology” have been thrust into our lexicon, and with thousands of clinical trials related to COVID-19 taking place, now is a good time to review some basics.
What are clinical trials?
“Clinical trials are part of clinical research and at the heart of all medical advances.”
- National Institutes of Health (NIH)
Without clinical trials, there would be no new treatments, vaccines, medicines, or medical devices. Clinical trials – and the regulatory standards that govern the process – have evolved over decades to demonstrate safety, effectiveness and risk profile, and provide us with the very best information to avoid unpredictable, and potentially dangerously volatile, reactions and responses to new treatments.
Clinical trials are research studies that help us learn more about diseases and health conditions and how to prevent or treat them. They are how we test new vaccines and medications in people to see if they are safe and effective. Clinical trials also help us test new medical devices and procedures as well as changes in behavior, such as changes in diet, all in an effort to find ways to improve our health.
During clinical trials, researchers discover how differences in people—age, race, sex, genetic makeup, health complications, etc. — can affect how individuals react to a treatment, giving them the opportunity to learn from this feedback and ensure treatments are both safe and effective before the treatment is approved for use within the general population.
For those participating in a clinical trial, this process is done under the close supervision and care of medical professionals, and in accordance with strict guidance from regulators (FDA, EMA etc.) to ensure trials are as safe and ethical as possible.
Clinical research is done in a series of clinical trial phases. Each phase helps answer different questions about the treatment being tested.
Phase I focuses on how safe a new treatment is and side effects it may cause.
Phase II looks at how effective the new treatment is, along with safety and side effects.
Phase III tests the new treatment in more people to confirm effectiveness and monitor side effects.
Phase IV studies safety and effectiveness after a treatment is approved and made available to the public.
Who can be in a clinical trial?
Each clinical trial has specific requirements for who can be in the trial – called “selection criteria”. People who want to be in a clinical trial will be screened and meet with a doctor working on the trial. The doctor reviews their medical history and conducts medical tests to see if they meet the requirements.
Clinical trials do not promise direct health benefits. People choose to be in clinical trials for a variety of reasons. Some people want the chance to receive a treatment not available outside the clinical trial. Some look at clinical trials as a way to play a more active role in their healthcare. Clinical trials can be a way for them to learn more about their health condition or disease. Some people enjoy being part of medical research that may help others in the future. Some clinical trials also offer financial compensation.
Are clinical trials safe?
All of the rules and ethics that doctors must follow to practice medicine apply to clinical research. Each clinical trial follows a written plan called a protocol. This plan ensures that clinical trial activities, such as medical tests, follow standards and regulations. Ethics Committees and Institutional Review Boards review and monitor each clinical trial closely to safeguard the rights and welfare of participants.
During a process called “informed consent” a doctor or someone else working on a clinical trial explains the details of the trial. This includes what will happen in the trial and how long it will last. Being in a clinical trial is completely voluntary. Those who choose to join a clinical trial can change their minds and leave the trial at any time, for any reason.
Interested in being in a clinical trial?
Clinical trials play a critical role in the development of safe and effective treatments. There are many active clinical trials recruiting today, with even more upcoming, and we could certainly use your help. If you’re interested in joining a clinical trial or just want more information, talk to your healthcare provider.