Read This Before You Volunteer for a Clinical Trial (and Then Sign Up)

In the name of science, I’ve agreed to spend five weeks sitting in a room that’s been cooled to 40 degrees, for 16 minutes each time. I will be dressed only in a sweat suit, and while my fingers turn purple and white, I will be asked to rate how numb and painful my hands become. And I’m really excited to be doing so.

I’m participating in a clinical trial of an investigational topical medication for Raynaud’s disease. How appropriate that October is Raynaud’s Awareness Month.

I’m excited even though I feel like I “failed” the only other trial I participated in, which tested the impact of biofeedback on controlling headaches. It worked for most participants, but not for me. Then again, I’m not great at slowing down.

The fact that I’ve decided to volunteer for a second trial apparently is not uncommon; data show that 95 percent of individuals who participated in a clinical trial would consider enrolling in another. But the fact that I chose to participate in even one clinical trial does make me somewhat unusual.  Only 16 percent of those polled said they or someone in their family had ever participated in a clinical trial.

Because I’ve worked with researchers over the years, I thought I knew a bit about clinical trials. However, I learned a lot in my first visit with the study coordinator and principal investigator and in subsequent internet searches. Here’s what I discovered that may help you if you’re considering participating in a clinical trial. (Nothing in this post should be construed as medical advice. Consult your physician before joining a clinical trial.)

• Know Your Motivation. The vast majority of individuals choose to participate in a clinical trial if they think the treatment being studied will help them. Among those with severe disease, the opportunity to help others ranks high among their reasons for enrolling in a trial. You are more likely to enroll if your physician recommends a trial (mine did), but fewer than a quarter of physicians do so. Remember that you may not receive the study medication, and it may be years before a new treatment is approved. But, consider too, that certain groups, including women and minorities, have traditionally been underrepresented in clinical trials. Your participation could help researchers understand important differences in how diseases present and are treated.

• Understand Informed Consent. Federal law governing the protection of human subjects requires that researchers obtain your consent to participate in a clinical trial. As a study participant, you have certain rights, including the right to be told about benefits and risks of the study and how the study will be conducted. You also have the right to refuse to participate for any reason, at any time. In my case, the study coordinator was not even allowed to take my weight and blood pressure until I read and initialed each page of the consent document. These forms are reviewed by an Institutional Review Board designed to protect your welfare. Don’t think of informed consent as a single document or point in time; instead, view it as an ongoing conversation between you and the research team.

• Ask Questions. You can’t give truly informed consent unless you know what you’re consenting to. You may want to know about the study design. In randomized controlled trials (RCTs), one group of participants— the experimental group—receives the intervention, while a second group serves as a control. The control group may receive a placebo or usual treatment. Many RCTs are double blinded, meaning neither researchers nor study subjects know who is receiving the intervention. I’m participating in a crossover design study, in which all participants receive both the study medication and a placebo, in effect serving as their own control group.

You may also want to know what phase of the study you are in. Human clinical trials proceed in four phases. My trial is phase II, designed to gauge the effectiveness of a drug or device that has been evaluated for safety and potential side effects in a phase I trial. Also be clear about how your health information will be used and protected.

• Do Your Own Research. Remember that giving informed consent is an ongoing process. It’s never too late to seek information and ask questions. CenterWatch has a wealth of patient resources that include basic information on clinical trials and informed consent. gov features a worldwide registry and database of publicly and privately supported clinical studies. You can conduct both basic and advanced searches for conditions, interventions, and locations.

• Consider Volunteering. To be sure, participating in a clinical trial can feel like being a human guinea pig. Most people who choose not to participate say they are concerned about the risks or they don’t want to take a chance with their health. And these concerns are not to be taken lightly. But the lifesaving medication or intervention you receive tomorrow may have been tested on participants just like yourself today. Talk to your doctor. Search for available trials on gov, CenterWatch, and The Center for Information and Study on Clinical Research Participation (CISCRP). Do your homework and then take the plunge. Just remember, you may need to wear warm socks!

Susan Milstrey Wells is part of the GovLoop Featured Blogger program, where we feature blog posts by government voices from all across the country (and world!). To see more Featured Blogger posts, click here.