Doctor Decoded: What Are Clinical Trials?

Clinical trials are crucial for medical advances, which can help save lives.

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You’re having a conversation with your doctor about your treatment options, and they suggest participating in a clinical trial. You hesitate—is that dangerous?

Not necessarily. Every treatment available today had to be tested first as part of the drug development process by the U.S. Food and Drug Administration (FDA). Clinical trials are part of that process.

The Purpose of Clinical Trials

Researchers use clinical trials to test a drug (or a surgical technique or medical device) on humans to make sure it is both safe and effective. For example, any new vaccine for COVID-19 has to undergo clinical trials to ensure that it actually does help prevent COVID-19 without causing any adverse effects in humans.

Additionally, a clinical trial may take an existing treatment and see if it can work for people with a different condition. For example, in many cases, a treatment for rheumatoid arthritis may help patients with psoriatic arthritis—but this new usage would need to undergo clinical trials before getting FDA approval.

Clinical trials are crucial for advancing treatment options, which can help save lives. Without clinical trials, doctors would not have new and innovative treatments like cancer-fighting immunotherapy in their toolbox.

Are They Safe + Ethical?

As important as clinical trials are, testing out new medicines or devices on humans comes with some inherent risks. That’s why there are copious rules and regulations to help keep participants safe.

For starters, all participants are volunteers who give informed consent. That means they are participating willingly, and they receive all necessary info about the process, the purpose of the trial, and other logistics.

Additionally, the medicine or device undergoes testing before researchers test it on humans. Here’s how the process for FDA approval works:

  1. Researchers develop a treatment in a lab.
  2. The drug undergoes laboratory and animal testing to prove basic safety.
  3. Researchers test the treatment on humans to prove it’s safe and effective, and this is when clinical trials happen. Clinical trials occur in phases—first to a small set of healthy volunteers, and then to increasingly larger groups of people with the disease.
  4. FDA reviews the submitted data and decides whether it receives approval.
  5. Once the medicine or device gets approval, the FDA continues to monitor its safety.

Why Participate?

People choose to participate in clinical trials for a host of reasons. For some, their motivation is simply the love of science and helping to further medical advances. This may be especially true for otherwise healthy people who volunteer for clinical trials on new vaccines.

Sometimes, participating in clinical trials may be more strategic. Patients may have a rare disease that is difficult to treat, or standard treatments have not been successful against their condition. For these people, a clinical trial may offer new hope. It may be their only real chance at survival or improving their quality of life.

Similarly, some people may choose to participate in a clinical trial if they don’t have much hope for their own outlook, but hope that the potential new treatment could help improve life for future patients.

Whatever the reason, clinical trials are an essential part of health care that can benefit generations of future patients. You can find enrollment opportunities for clinical trials at ClinicalTrials.gov, or you can talk to your doctor about possible clinical trials for your condition.