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Human tests of new medical treatments lag due to lack of volunteers

October 06, 2008|By LEE BOWMAN / Scripps Howard News Service

Most people, even when they're deathly ill, don't consider the possibility that they might be able to get an experimental drug or device to treat their condition.

New medicines may start with gene chips, test tubes and lab rats, but they have to be tested in real people before being cleared for use by the U.S. Food and Drug Administration.

Yet numerous surveys show few patients realize there are clinical trials going on for what ails them, and even those who are aware are often leery of taking part.

As a result, testing of genuinely new treatments has fallen behind, one reason that approvals of new drugs has slowed.

A shortage of patients also means the quality of testing has suffered. That's because researchers are forced to widen the criteria that must be met for patients to take part, which often means the data collected is less definitive about whether the new drug works or is superior to existing treatments.

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The situation is particularly acute for cancer drugs, with 80 percent of clinical trials delayed because of a shortage of patients, according the American Association for Cancer Research.

A survey of 6,000 cancer patients done for the association found that 85 percent were either unaware or unsure that taking part in an experimental treatment was an option for them. But 75 percent said they would have been willing to sign up if they'd known it was possible.

In fact, most surveys of patients who've done a clinical trial find they'd take part in such an endeavor again.

But that doesn't mean that experimental treatments are for everyone, or that they're all run in the same way.

Keep in mind that private companies sponsor about 80 percent of roughly 80,000 clinical trials done in the United States each year, and about 30 percent of the trials done by pharmaceutical companies are outsourced to clinical research organizations, which are commercial firms that set up and run clinical studies in hospitals and their own facilities.

A big chunk of commercial drug testing is devoted to proving the effectiveness of "me-too" drugs -- variations of treatments that are already on the market.

Clinical trials run by academic medical centers may be sponsored by drug companies, too, or through grants from independent foundations or government entities like the National Institutes of Health.

So, one of the key questions to ask when considering taking an experimental treatment is just how new or innovative it is, and what the study seeks to prove.

Generally, the FDA requires that any treatment first be tested to prove that it's safe in humans. These tests typically involve only a small number of volunteers, who may or may not be ill.

Then testing moves on to demonstrate that the treatment has a positive effect on preventing or treating an illness at a certain dose, and that the effect is as good or better than the current standard treatment, or no treatment at all. Usually, researchers try to get from tens to hundreds of patients in these trials. Most study guidelines require that neither patients nor the doctor caring for them know whether they're getting the new drug or not.

The third phase of a drug or procedure trial pits the new against the best standard treatment in several thousand patients, unless the disease or condition is rare. Usually, all medical care costs connected with the treatment are covered in the second and third stages.

Researchers, of course, would prefer that the only thing wrong with you be the condition they're trying to treat, but that's seldom the case, particularly for older patients. So it's important to find out how other medical care and visits to your regular doctor will be coordinated.

FDA oversees only trials that will be used to seek approval for sales. "Pure" medical research sponsored by the federal government is overseen by the Office for Human Research Protections in the U.S. Department of Health and Human Services.

In either case, a patient being recruited for an experiment has a right to a verbal and written explanation of all details of the study, including the possible risks and side effects from the care, what options are available to care for you if you have a bad reaction, and what alternatives you have to the treatments being offered through the experiment.

And the patient always has the right, even after signing consent forms, to drop out of a study at any time.

E-mail Scripps Howard News Service Health and Science Correspondent Lee Bowman at bowmanl@shns.com

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