Clinical Trials

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Information about clinical trials has become easily accessible, thanks to the Internet. Today, both healthcare providers 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.

Healthcare providers 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. Healthcare providers often 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. Issues for patients considering participation in clinical trials include:

• Risks and benefits of participating in a particular study
  Patients need to understand fully the potential risks of participating in research studies and should be given detailed information about both risks and benefits.

• Study details — What is expected of the study participant
  Patients need to understand exactly what their participation will involve, in terms of the time and travel involved as well as actual research procedures, testing, administration of experimental drugs, or whatever is necessary.

• Sponsorship and purpose of study
  Patients need clear information about who is carrying out the study and the purpose of the study to help decide whether or not to participate.

• Study costs and insurance coverage
  Costs can be an important issue. The patient should know whether or not all costs will be covered by the study sponsors, and if compensation will be provided to participants. If not, will the patient's own health coverage pay for any costs involved? Health insurers have differing policies and it is important for the patient to know what to expect. 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.

Current as of November 2007