Health Professionals: Your Role in Women's Health

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Clinical Trials

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• Resources for Patients
• Resources for Health Professionals

Information about clinical trials has become easily accessible, thanks to the Internet. Today, both health care professionals and patients with access to computers can search online for clinical trials of possible interest, learn which trials are recruiting participants, and learn about eligibility criteria and other details of a study.

Health care professionals can be important resources for patients who are considering joining or participating in a clinical trial. They can offer continuing health care, education, and guidance throughout the patient's process of identifying, enrolling, and participating in a trial. You may want to take an active role in helping a patient make necessary contacts to join a trial or work out details of how costs will be covered, including contacting the patient's health insurance company. Even if you’re not actively helping your patient with the trial, make sure they are aware of these issues:

• Risks and benefits of participating in a particular study
  Could participation be dangerous? Make sure the patient understands that clinical trials test whether a treatment is safe and effective. Unexpected outcomes may occur. However, the benefits may outweigh the risks. Patients should examine both.

• What is expected of the study participant
  What will participation involve? Patients should ask about how much time and travel are involved. They should also make sure they understand the research procedures. What will they be doing? If they’re in a drug trial, is it an experimental medication?  

• Sponsorship and purpose of study
  Who is carrying out the study? Is it a legitimate institution? What is the purpose of the study?

• Study costs and insurance coverage
  Costs can be an important issue. The patient should know whether costs will or will not be covered by the study sponsors, and if compensation will be provided to participants. If trial participation costs are only partially covered or not at all, patients should check with their health insurance provider ahead of time to learn what their policy will and will not cover. Health insurers have different policies regarding reimbursement of trial-related costs. Medicare now pays for routine patient care costs and costs related to medical complications associated with participation in clinical trials, and a number of states have passed legislation requiring health insurers to pay for similar costs. However, some exclusions are usually included in policies.

Content last updated December 1, 2008.