In observing International Clinical Trials Day for 2017 on May 19, Health Decisions wishes to thank all those who participate in clinical trials. Health Decisions especially thanks patients enrolled in our current trials but we want to thank trial participants everywhere for making clinical development possible.
While sponsors and CROs like Health Decisions make every effort to minimize the inconveniences and risks associated with participating in a clinical trial of an investigational drug or device, challenges are unavoidable for patients in areas where at least one existing treatment offers some efficacy. The decision to discontinue an existing treatment reflects a substantial commitment on the patient’s part.
Potential Risks and Benefits of Trial Participation
Challenges of trial participation vary with the type of medical product under test. For contraceptives, we must recognize that women have to think twice before agreeing to discontinue an effective, well-tolerated method. For therapeutics, the sacrifice involved in trial participation is proportional to the benefits provided by existing treatments. Patients enrolling in a trial of a new analgesic know they are running the risk of experiencing additional pain. Even with provision for rescue medications, patients must consider a nontrivial risk before giving informed consent to participate in a trial. With a bothersome health condition where existing treatments have limited efficacy or notable side effects, patients can hope for improvement from the investigational medication. However, there are no guarantees.
The challenge of trial participation is most notable for placebo-controlled clinical trials. It is no small thing for patients to accept the risk of randomization to placebo. This is a clear case of sacrifice by a few to enable potential benefits for many. In Health Decisions’ experience, when the informed-consent process discloses the risks of trial participation, women understand the risks but often choose to participate in a trial out of a desire to improve future healthcare for their daughters and friends. Altruism of this kind deserves the highest praise.
To be sure, there are patient stipends in many trials. However, these typically compensate for inconveniences such as transportation to and from office visits. A patient stipend may offset the burden of trial participation. In no way does a typical patient stipend compensate a patient for accepting the potential risks associated with discontinuing an existing treatment in order to try an investigational product.
On International Clinical Trials Day, our hats are off to the unsung heroes whose participation in clinical trials is essential for medical progress.