6 Reasons to Participate in Clinical Trials
/By Dr. Lynn Webster, PNN Columnist
The COVID-19 pandemic has left many people feeling helpless -- yet you can help defeat the virus. You may not be a medical researcher, but you can still be part of developing a vaccine. There are three COVID-19 late-phase vaccine trials currently underway in the United States, and they will involve more than 100,000 individuals.
All stages of research require volunteer subjects. Early-phase trials require healthy volunteers, who may not directly benefit from a vaccine or medication but participate for other reasons. The current COVID-19 vaccine trials, for example, involve people who do not have the infection. Some will receive the new vaccine and others will get a placebo.
Only after volunteers are exposed to the virus can scientists determine if the vaccine is safe and effective when compared to a placebo. If a participant becomes ill because of exposure during the trial, the sponsor of the study generally pays for their medical expenses.
Not all clinical trials involve a placebo, but most do. Later-phase trials may offer benefits to the volunteers who have the disease or condition that the drug targets.
There are various ways to get involved in a trial. You may be invited to join one of these trials. Your physician may be part of network of providers participating in a study. If so, they can offer you an opportunity for enrollment. Or, if you are looking for a specific treatment, you can go online to find a study that may be of interest to you.
Here are six reasons to consider participating in a clinical trial:
1) Clinical trials provide safer and more effective therapies
Without clinical trials, development of new and more effective treatments would not be possible. Medical advances depend upon people who are willing to participate in trials. Every drug, from vaccines to pain treatments, approved by the FDA has been studied in clinical trials.
2) Clinical trials provide you with free access to a new treatment
When I started to treat people in pain, I conducted clinical trials to provide my patients with cutting-edge technology that was not yet publicly available. I wanted my patients to have access to the best and newest therapies in the pipeline.
Of course, there was no guarantee that the experimental therapies would be effective. However, the treatments were free to participants in the trial. If the risks were perceived as acceptable, it could be worth it for patients to take the chance.
3) Clinical trials can save your life
Late-phase clinical trials, such as the three currently underway for COVID-19, may provide immunization that could save the life of the participant. Through other clinical trials, we have provided lifesaving therapies to subjects who otherwise could not have obtained them because they couldn’t afford the treatments, or the treatments simply were not available to consumers.
4) Clinical trials can save a loved one’s life
Clinical trials provide researchers with more knowledge and potential therapeutic options. Participating in vaccine trials can lead to the approval of a treatment. This could save the life of a family member who may one day need a vaccination or drug treatment.
5) Clinical trials are regulated by FDA
Clinical trials are highly regulated and generally regarded as safe. Most clinical trials sponsored by industry are required to have their protocols reviewed and accepted by the U.S. Food and Drug Administration, which assesses the safety of every trial. The agency will not allow a company to begin a trial that has not been fully vetted by several FDA departments.
In addition, all protocols must be submitted to an institutional review board (IRB) for approval. This is an independent body charged by the FDA to evaluate and monitor trials. The IRBs and principal investigators contract with the FDA to follow guidance from the Federal Office for Human Research Protections. Both IRBs and principal investigators can be criminally charged if they fail to adequately monitor and accurately report results of a trial.
When the FDA grants permission to fast-track a particular therapy because of an emergency situation, protocols may be loosened. The potential benefits, in that case, have been determined to outweigh the risks. We have to hope that the accelerated approval process for a COVID-19 vaccine will not cause adverse events.
Prior to enrolling in a trial, participants are provided with an informed consent form that describes the trial in layman's terms and explicitly states all of the potential risks. Participation in clinical trials is always voluntary, and a person can withdraw from a trial at any time.
6) Clinical trials may compensate participants
Some trials compensate participants for their time and travel. This occurs more often in early-phase trials for which there is no clear clinical benefit to the individuals. Most trials requiring participants to stay overnight in a research facility compensate volunteers. Participants' compensation depends on the amount of time the testing takes and the types of tests that are performed.
Compensation must be reasonable, yet not excessive. Compensation ranges from $50 or less for a simple saliva sample to $10,000 or more for studies that require staying in a facility for 30 days or so.
You can learn more about clinical trials at the National Institutes of Health website or by visiting the Clinical Trials website. The National Institute of Allergy and Infectious Diseases also has a website to connect volunteers to coronavirus vaccine trials. And COVID Dash has a portal where people can volunteer for dozens of coronavirus studies around the world.
One clinical trial may create the breakthrough that helps us get the pandemic under control. But that can only happen if enough people from a variety of demographics are willing to volunteer to be a part of the effort.
Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD.
