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Medical clinical research slows for lack of patients

Enrollment shortages have delayed or canceled trials on experimental therapies. Researchers are trying to reverse that trend, in part by using databases to connect patients with possible new cures.

March 14, 2009|Shari Roan

A year ago, U.S. researchers launched what they deemed a high-priority study to determine if women with an often-fatal type of breast cancer could live longer by taking a specific combination of drugs. If the study found that to be true, the average rate of survival -- four years -- could be significantly extended.

A worthy question to address? It would seem so. But the answer may be a long time coming.

The U.S. arm of the international trial got underway nine months behind those in other countries. And researchers now expect to enroll only 350 U.S. patients of the original 3,500 sought.

Before drugs and therapies to save lives or reduce suffering can reach the market, they must be tested to ensure they're safe and effective. But the reluctance of Americans to participate in clinical trials has been a serious drag on medical research.

Enrollment problems delay more than 70% of clinical trials from one to six months, according to a 2007 survey by CenterWatch, a Boston-based company that publishes information on clinical trials. In cancer care, less than 5% of patients enter clinical trials, even though more than 700 cancer therapies -- many that are highly promising -- clog the research pipeline.

"It's a major issue," says Dr. E. Ray Dorsey, a neurologist at the University of Rochester Medical Center who has studied the issue. "Many trials are started and never finished because they can't complete enrollment. A lot of money is wasted."

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A daunting task

To test a promising treatment -- whether a pill, injection or procedure -- researchers usually need large groups of people who have a specific illness and who are, for comparison purposes, of a certain age, ethnicity or gender. Sometimes they even need patients with a particular gene or complication. Then they must track the patients for several months or years to see if the therapy worked and how it compares with the standard treatment.

It's no small task. And with 2,800 drugs and medical therapies now in development -- awaiting solid data on efficacy and outcome -- doctors, researchers and drug companies are finally taking a hard look at how they can persuade more people to participate.

To that end, initiatives to boost clinical trial participation are underway across the country.

Some medical centers are offering simple perks, such as arranging transportation for participants; others are using computer programs that notify doctors if a particular patient might benefit from a trial. Researchers, meanwhile, are avoiding use of the word "subject" and even agreeing to meet with trial participants after the study to answer questions. Everyone, it seems, wants to convince potential participants that they will be cared for and valued.

"It's sort of ironic that there are more compounds available to study than ever before, and most are based on some new scientific principles, yet we are still having trouble recruiting participants," says Diane Colaizzi, executive advisor of the nonprofit Coalition of Cancer Cooperative Groups, founded by research groups to promote study participation.

Although cancer research receives the most publicity, the need for participants plagues almost every area of medical research. This month, the Huntington's Disease Society of America in New York e-mailed its members asking people afflicted with the fatal genetic neurological disease to consider clinical trials.

The letter, from the group's executive director, Barbara Boyle, noted that a recent three-month trial on a potential drug treatment took more than nine months to enroll and another promising trial may take even longer.

"Our scientists and clinicians have done what they can to reach this point," Boyle wrote. "Only you can make the final steps possible."

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Researcher failings

Part of the blame for limited participation in clinical trials lies with researchers.

They acknowledge that some trials have been poorly conducted, risking patient health and dimming the public's view of medical research.

Researchers also say they have failed to explain to patients that clinical trials often present two choices of care: the best established treatment or that treatment plus an experimental therapy.

"I think there is a misperception by the majority of people that it will take away from their treatment and won't do them any good," says Dr. Raymond DuBois, president of the American Assn. for Cancer Research and provost of M.D. Anderson Cancer Center in Houston. "At a bare minimum, we would offer the standard treatment option."

Patients may fear they would get only placebos -- dummy pills or treatments -- but those are used primarily in trials that assess prevention, rarely in treatment trials.

Nor are clinical trials necessarily a desperate attempt to stay alive only after all other treatment has failed. Says Dr. Robert L. Comis, president of the Coalition of Cancer Cooperative Groups: "Nowadays there are trials for all stages of disease. It's a myth that this is something of last resort."

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