Encouraging Education Before Participation
Advocacy We need more participants in clinical trials, but before you or a loved one signs up, it’s important to weigh the pros and cons.
Your decision to participate in a clinical trial is very important — one that must be taken seriously and requires you to do your homework and gather as much information as you can.
Most people begin the process of learning about clinical trials when it is very difficult to do so. Facing a sudden and often unexpected diagnosis, people gather information and make decisions quickly — sometimes hastily — at the same time they are adjusting to their new reality.
“The many people whom you meet in a clinical trial can greatly enrich your knowledge.”
A good place to start the learning process is to address the common misconception that receiving treatment in clinical trials is the same as receiving medical treatment as a patient. When you’re a study volunteer, you typically feel like a patient in a doctor’s office. You’re examined by a doctor, undergo lab tests and other common procedures and receive a medication. But the difference is that a doctor’s primary goal is to help you feel better, whereas in a clinical trial, the principal investigator’s primary goal is to see how you will react to a new drug and determine whether that drug will be safe and medically useful.
This truth doesn’t change the fact that many people feel better while on an investigational drug. Some investigational products prove to be far superior to the older drugs they will one day replace. Some drugs administered during clinical trials have not only improved but also saved thousands of lives. But the opposite is also true: some drugs administered during clinical trials have worsened people’s conditions and have caused death.
Considering the outcomes
Each volunteer’s outcome in a clinical trial depends not only on the specific study in which they participate, but also into which part of the study they are randomized. Subjects who get randomized into the control group will, at best, get a standard treatment that is already available at pharmacies and drugstores. But they may also get free screenings and exams, the camaraderie of people dealing with the same medical condition, the opportunity to be an active player in their own health care and the knowledge that they’re helping to answer questions that can improve the health care of future generations.
Only about six percent of people who suffer from severe and chronic illnesses participate in clinical trials each year. As a result, an increasing number of clinical trials are delayed because there are too few study volunteers available.
Often the protocol eligibility criteria exclude many patients from qualifying to participate in clinical trials. Some people choose not to participate for fear that they won’t receive the experimental drug or that the risk of side effects and discomfort will be too great. Others are concerned about the inconvenience of having to periodically visit the research center and undergo a demanding schedule of procedures.
The most common reason people choose to participate in clinical trials is to gain access to a promising new medical therapy. Yet a surprising number of people choose to participate in clinical trials even when they personally have little, if anything, to gain by doing so. Some volunteers get involved because they want to contribute to the advancement of medical knowledge or to help people suffering from an illness. A few do it out of simple curiosity or because they believe study volunteers get better medical care and attention.
Some study volunteers participate primarily to earn extra money. Payment is most often used as an incentive to recruit healthy volunteers who derive no direct benefit from the research, such as in most phase I studies. Some choose to participate in clinical trials because they don’t have health insurance and need help covering medical treatment costs. Study volunteers in clinical trials almost always get free medication, as well as physical exams and other medical services like blood tests and heart assessments.
Deciding to participate
People who participate in clinical trials often learn a great deal more about their illness and about other conditions (including underlying heart disease and diabetes) they may not have known about. Study-related x-rays, lab tests and physical exams have picked up unsuspected cases of many types of cancers early enough to be successfully treated by specialists. For some participants, the best end result of a clinical trial is that they start taking better care of their own health.
An important benefit for all clinical volunteers is the opportunity to meet research professionals who can help introduce them to other patients suffering from similar illnesses. Volunteers also may meet scientists and professionals who can help them better understand their illness and can tell them about new treatment options under development. The many people who you meet in a clinical trial can greatly enrich your knowledge.
At the Center for Information and Study on Clinical Research Participation (CISCRP), our motto is Education Before Participation. Our motto applies to everyone, including patients and their families, health professionals and the general public. Education Before Participation guides everything that we do, from the many educational print and digital materials that we publish and make available on our web site to the many live educational seminars — called AWARE for ALL programs — that we produce in major cities throughout North America and parts of Europe each year. These initiatives are all provided free-of-charge to patients and the public.