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.
Aldige points out that clinical trials have a high degree of protection forpatients. Every trial is approved by the FDA to assure that the productbeing tested will be safe, and by an institutional review board, consistingof experts at the institution where the trial is taking place. The reviewboard, among other things, assures that patients receive theinformation they need to decide whether to participate.
A patient must sign an informed consent form to participate in a study. A good informed consent form will tell them what the therapy is for, whetherall patients will receive an active drug, what the possible or expectedbenefits are, and what the risks may be.
During clinical studies, extensive information is gatheredfrom the patients -- their disease or condition, how they react to thetreatment, and potential side effects, which will be monitored.
The health sections of newspapers are filled with advertisements forclinical trials, for everything from sleep disorders to depression to highcholesterol to menopausal symptoms. Drug investigators must advertise torecruit patients with the exact criteria they are seeking. Increasingly, the Internet is beingused for recruitment. The National Institutes of Health recently launched its own web page to listclinical trials and the medical criteria for entry:http://clinicaltrials.gov.
Aldige and other experts advise people with diseases that do not have fullyeffective treatments to explore -- through their physicians, newspapers, or the Internet -- the possibility of enrolling in clinicaltrials. Not only will these patients benefit, but the more people who enroll, themore quickly new therapies will become available for people who may need them in the future.