Volunteers for Clinical Trials Are Partners in Medical Advances

Advances in medicine come through scientifically rigorous experiments designed to create new therapies that are safe and effective.

Every one these advances relies on the participation of volunteers who step forward to take part in clinical testing.

"Some people themselves may benefit for their particular problem, and others participate because they know future generations may benefit," says Theodore Kotchen, MD, Medical College of Wisconsin Professor of Medicine, who specializes in endocrinology. Dr. Kotchen also serves as Associate Dean for Clinical Research and Director of the General Clinical Research Center.

"For example, we're doing a major test on the genetic roots of high blood pressure among African-Americans, because it is so extraordinarily high in that community," Dr. Kotchen explains. "Unfortunately, it's unlikely that it will benefit our volunteers directly, but as we learn more about causes and treatments, it will pay off for their children and grandchildren."

Each year, hundreds of clinical tests are being conducted at the Medical College of Wisconsin, and all are dependent on the participation of volunteers. Before any clinical tests proceed, they are screened carefully by the Medical College of Wisconsin's Human Research Protection Office to ensure that maximum safeguards are in place for patient safety.

Moreover, participation is strictly up to the volunteer. "Anyone who is thinking of being involved must be fully informed of the procedures in the test and all the risks," says Dr. Kotchen. "Once the participant hears the explanation and reads over what the test entails, there is a consent form to be read and signed."

But the consent form is not a contract that binds participants to continue the test if they feel uncomfortable in any way. "Taking part is totally voluntary, and a participant may elect to withdraw at any time. In no way will this affect their care or our willingness to provide them care," the doctor states.

Here some questions that people considering participation in a clinical test may have:

Am I more likely to be cured of my condition if I take part in a test?

Not necessarily. Your treatment is mainly in the hands of your primary physician, whose mission is to find the best course of handling your medical problem from a range of already-proven drugs, procedures, and behavioral interventions. The clinical test - for a new or existing drug or a new therapy - has a different aim. While safeguarding your health, the goal of the clinical test is to determine if a drug or therapy is safe and effective for large numbers of people.

Sometimes, this may result in an improvement in your condition. More generally, however, the benefits of the test will be experienced by patients in the future.

How do I know if a clinical test is right for me?

In a confidential meeting, you will learn why you have been approached about taking part in the test. The selection is typically based on age, gender, type and stage of the condition, previous medical history, and other medical considerations.

The purpose of the clinical trial will be thoroughly outlined, along with the potential benefits and risks. It will be described in detail, including its duration, the frequency of testing required, and activities required between tests. Alternative options for the treatment of your condition will also be outlined. The future use of the clinical trial will be explained. A few tests offer participants a small payment or reimbursement of costs.

How can I be sure that the clinical trial will be safe for me?

Before any clinical trial is launched, the Human Research Protection Office thoroughly scrutinizes the proposal for the test. This scrutiny is undertaken to make sure that all ethical guidelines are followed and that every possible measure is used to assure patient safety.

Participants are encouraged to take an active role in order to feel safe. If any confusing terms are used, feel free to ask what they mean. Whenever there is a doubt, speak to the staff to make sure that you have the same understanding. They will welcome your questions.

How do I decide if I want to take part in a clinical trial?

First of all, give yourself some breathing space. Many people are naturally inclined to please the researchers and are eager to help out with an advance in medicine. But it is important to take some time and fully understand the clinical trial and what it will mean for you personally.

Also, absorbing new developments about your medical condition can place you in a fragile emotional state where you might be tempted to make impulsive decisions. Take the time that you need to feel good about your decision. Consult with people whose judgment you trust - family members, primary care physicians, friends, or representatives of the clergy can offer support and advice.

I hear that I must sign an Informed Consent Form in order to take part. Why is that?

Clinical trials depend on all participants being fully informed of all the implications of the test. They deserve to know what to expect and what their rights are. The consent form is for the patient's protection.

If I take part as a volunteer in a clinical trial, what exactly are my rights?

• You have a right to genuinely volunteer, and not be pressured into participating.
• You have a right to confidentiality about your medical condition and history.
• You have a right to receive information in terms that make sense to you, and a right to keep asking questions until you get a clear answer.
• You have a right, if a problem arises, to have access to advocates for your rights, including a Patient Advocate and Research Study Advocate.
• Finally, you have a right to withdraw from the clinical trial at any time. The consent form is not a contract that binds you to continue the test. Your participation is voluntary.

Dr. Kotchen stresses that the Medical College views volunteers for clinical trials as partners in the process of making medical advances that will benefit large numbers of people.

"We want to see our volunteers making informed decisions about participating, and then helping us in discovering more effective, safer therapies," he says.

For further information on volunteering for a clinical study, see "Is a Research Study for You?". The CD of the same name can be obtained by calling Noreen Wynn at 414-456-8167.

For more information on this topic, see the HealthLink article New Ways to Protect Research Volunteers.

MCW Health News presents up-to-date information on patient care and medical research by the physicians of the Medical College of Wisconsin.