Advice for Subjects

(Adapted from Chasing Medical Miracles: The Promise and Perils of Clinical Trials. A more comprehensive version is available as an Afterword in the book.)If you’re thinking of volunteering for a clinical trial here is some information you should keep in mind.

Before You Decide to Enroll

1 – Volunteering for a clinical trial is a legitimate option you might wish to consider if you’re seeking a new way to address a medical condition you have. However, clinical trials are not medical treatment. You might benefit from a trial, but that is not the reason the trial is being done. The trial is being conducted to gather data – period, end of story.

2 – Volunteering for a trial to help others and advance medical science is honorable. Many people feel compelled to “give back” or to sign up for a trial exploring new treatments and drugs for a condition a family member or loved one suffers from. If such an option feels like something you want to do, then by all means consider it.

3 – Finding a clinical trial is not difficult. There is a very comprehensive listing of more than 50,000 open trials prepared and maintained by the National Institutes of Health at www.clinicaltrials.gov. Another good listing site is www.centerwatch.com, a for-profit information services company that serves the clinical trials industry.

Consent and Questions

1 – When you first visit the sponsor of the trial, be aware with whom you are speaking. Ask the person you are meeting with to describe to you their role in the trial.

2 – For your first visit (and for visits afterward) take someone with you. This is helpful because you are going to be receiving a lot of information and it’s difficult to just process it all on your own without having someone to review it with you.

3 – Informed consent is crucial to the clinical trials process. It is a federal regulation that you give informed consent before the trial. If you are not offered informed consent along with an informed consent form to review and sign before you take part in the trial, do not take part in the trial. Ask for the opportunity to take the consent form home to study and discuss it with others.

During the Clinical Trial

1 – At any point during the trial you can drop out. This is a guaranteed federal and international right.

2 – Be sincere about your involvement. Keep a diary if it’s required. Go to all appointments you agreed to go to. Take all the tests you agreed to take. Adhere to the guidelines you agreed to when you signed up.

3 – Continue to ask questions. You should ask and expect answers to questions about the clinical trial overall, about your test results, about results thus far from the trial, and side effects, about what to expect in the next step or steps in the trial, and about anything else that you are not clear about or that you are merely curious about as you proceed through the trial.

4 – Ask the research team to copy your primary care physician on all your test results. Let your primary care physician know you are asking this and to expect these test results.

5 – Take an active role in the study. You are a partner in the research and as such you should continue to research the area the trial is studying and the progress of the trial and related studies.

6 – Ask the sponsor or the patient coordinator for the results of the trial as it progresses and when it’s concluded. Knowing exactly what’s happening and what happened is important for your own peace of mind.