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The Benefits of Clinical Trials

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WebMD Health News

April 14, 2000 (Washington) -- A remarkable statistic arrived the other day from a company that recruits people to participate in clinical studies: 80% of clinical trials fail to enroll the required number of patients on time.

The statistic defies logic. People who enroll in these studies often getbetter medical care than most other patients, can get an advanced therapythat generally is not available to other patients, and usually receivefollow-up monitoring to assure their safety.

Why, then, is it so tough to find people willing to enroll in a clinicaltrial?

There seems to be a number of barriers:

  • The medical criteria usually are strict. A clinical study can reachvalid scientific conclusions only if all the patients have similar medicalconditions and meet very exacting requirements. Sometimes it's hard to findpatients who meet all the criteria.
  • Many patients believe that they may get a placebo, or dummy pill, if theyenroll in a clinical study. It is true that many studies areplacebo-controlled -- that is, some patients receive a placebo and othersreceive the drug being studied. It is also true that neither the patientnor the physician may know which patients are receiving the active drug. But not all studies areplacebo-controlled. In studies for medical conditions for which effective and safe treatments already exist, no one receives a placebo; patients get either the new drug being tested, or the accepted, approvedtreatment. Before deciding whether to participate in a clinicaltrial, a patient should know whether the alternative treatment is a placebo.
  • Recent news coverage of gene therapy trials, in which one teenager died duringa study, may be scaring off many prospective enrollees. This isunfortunate, but the reality is that recruitment was difficult before this death occurred.
  • Clinical trials can't even get respect in the theater. A play called"Wit," which recently appeared in Washington, is a powerful drama about aterminal ovarian cancer patient ("I'm at stage IV; there is no stageV," she says) who is enrolled in a study of an experimental drug. Thecharacter's physicians treat her more like a test subjectthan a human being. No one would want to be in a clinical trial afterseeing this play.

Experts who know how clinical trials actually function are in disbelief thatthe American public views them negatively. Carolyn R. Aldige, president andfounder of the Cancer Research Foundation of America, tells WebMD: "Anyonewith a cancer that cannot be effectively treated should aggressively seekout participation in a clinical trial. The chances of receiving the latestand best treatment is so much higher."

Aldige's organization is sponsoring a national survey in hopes of gaining a betterunderstanding of why people are reluctant to enroll in cancer trials. In cancer trials, she notes,patients always receive either the best standard treatment or an additionaltreatment that may be even more effective.

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