Should I Participate in a Clinical Trial?
The Role of Clinical Trials
Clinical trials are essential for the approval of new medicines, procedures, and devices, as well as for enhancing our understanding of diseases.
Every new medical advancement undergoes a rigorous clinical trial process to ensure it is safe, effective, and an improvement over existing treatments.
Understanding Risks and Regulations
Each clinical trial comes with its own set of benefits and risks, which will be thoroughly explained to you before you participate.
In the United States, trials are regulated by the FDA and reviewed by an Institutional Review Board (IRB). These bodies ensure trial safety and protect your rights as a participant. Participation is always voluntary, and you can withdraw from a trial at any time if you choose.
Benefits of Participation
Participating in a clinical trial contributes significantly to the advancement of medical science. Volunteers help pave the way for new treatments and discoveries. Additionally, trial participants often gain access to cutting-edge treatments and receive extra care and monitoring from medical staff, usually at no cost.
However, it's important to understand that while the treatment may offer potential benefits, there are also risks, which will be closely monitored by the medical team.
Financial Considerations
Financial factors can influence the decision to join a clinical trial. The additional medical care and monitoring provided during a trial are generally free of charge and often do not involve your insurance.
Some trials may also offer monetary compensation for your time and expenses related to extra visits, testing, meals, and travel.
What Is Required If I Join a Trial?
If you are interested in joining a clinical trial, you will receive an Informed Consent document and information about the trial to review before you make your decision. An Informed Consent covers all details of your participation in the trial.
Important Note
Take as long as you need to closely review the Informed Consent. Some participants benefit from discussing the trial with family, friends, and/or care providers. Your provider may even make recommendations regarding the trial and potential participation. There is no pressure to join, as it is always completely voluntary.
If you decide to participate, the study physician and/or study nurse or coordinator will review the Informed Consent with you again. Next, you will be asked to sign the consent and receive a copy for your records. The consent will outline the schedule of visits and tests you are to complete for the trial.
Your first visit is usually a screening visit to make sure you are qualified to participate. The study is designed to either include or exclude certain conditions which may interfere with the item being studied. If you pass the screening visit, you will then be enrolled (or randomized) into the trial. You will be given everything necessary for your involvement and scheduled for your next visit with the medical team. You may be asked to complete surveys on an electronic device supplied by the study sponsor. You need to be compliant with any study instructions regarding any medicine or devices. You will be asked to bring any unused medication back at your next visit so it can be accounted for.
Testing may include blood draws and lab tests, CT/PET (or other) scans, ECGs, and physicals (just to name a few). Trial participation may last several years, so it is important to understand this prior to participating. Again, at any time, for any reason, you may end your trial participation.
Will I Get a Placebo?
Most people know that a placebo is an inactive form of the medicine or device under study. Not all trials will have a placebo component, but some do. A computer will randomly decide whether or not a trial participant gets the active form or placebo. Neither you, nor usually your study team, will know which you have been assigned. This reason for this approach is to take any bias out of the results, and to prove that using the new treatment is more effective than not using it.
Placebos are rarely used alone in a clinical trial. These trials usually provide standard-of-care treatment to all participants (which you would receive if you were not in the trial), then add the new treatment (or placebo) to your regimen. This is especially true in cancer trials, as it would be unethical to give a placebo alone when there are approved, working treatments.