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Clinical Trials

By David Mendosa

Last Update: January 20, 2004

We have had an explosion of clinical trials in the past year or two. Maybe they need to be reigned in a bit.

What’s the advantage to the people?

Health & Human Services Secretary Donna Shalala thinks so. She just proposed huge fines on researchers and universities who violate government research rules. That will take congressional action. But she immediately put into effect tougher requirements that people taking part in clinical trials be fully informed of research risks and be more closely monitored.

Her action comes in the wake of the death of 18-year-old Jesse Gelsinger in a University of Pennsylvania gene therapy trial last fall. The government caught some flak for lax oversight of those trials.

Both the number of Web sites recruiting people to test new drugs and the number of studies on these sites have grown remarkably. The best indication comes from the granddaddy of clinical trials sites, the CenterWatch Clinical Trials Listing Service.

When I looked there two years ago, it reported on 58 diabetes trials. A year ago that number had shot up to 272. And now it has 350 plus 63 more about complications of diabetes.

Clinical trials are research studies to show whether new drugs or treatments are both safe and effective. Only after laboratory and animal studies show promising results are the drugs tested on people. The Food and Drug Administration doesn't approve any new drug without these trials.

Phase 1 trials—mostly of safety—test drugs on 20 to 100 people. That takes several months. Then, several hundred people spend up to two years in Phase 2 trials to test effectiveness.

Phase 3 trials have several thousand people using the drug for up to four years. Here safety, effectiveness, and dosage are all considered.

Drugs that successfully complete Phase 3 then go to the FDA with a New Drug Application, which can take as long as seven years to be approved. Only then can the companies sell the drug in the United States.

This shows that getting thousands of people to participate in these clinical trials is essential to the companies. But what's the advantage to the people being tested?

A new National Institutes of Health site, ClinicalTrials.gov notes four benefits:

"By participating in a clinical trial, you can take an active role in your own health care, gain access to new treatments that are not available to the public, obtain expert medical care at leading health care facilities during the trial, [and] help others by contributing to medical research."

But, as Secretary Shalala's action indicates, clinical trials also can have risks. Even if the treatment works for you, side effects can be serious. Plus, taking part in these studies can require a lot of your time.

Of all the new clinical trial sites, ClinicalTrials.gov is the most impressive. Unlike other such sites, these are primarily National Institutes of Health trials. But later this year the site will add trials by other government agencies and drug companies.

The other big new clinical trials site is Healthexchange. It has about 100 trials dealing with diabetes. Many of these trials will be in more than one city, each one of which CenterWatch counts separately.

Recombinant Capital, a financial consulting firm, offers a different way of looking at clinical trials. It is an excellent resource to find out what different drugs companies have in their pipeline.

Among the smaller clinical trial sites, most interesting is New Diabetes. This SmithKline Beecham Pharmaceuticals site is recruiting people with diabetes for Phase 4 trials (postmarketing surveillance) of Avandia. This company seems to be the only one so far to sponsor its own clinical trial site. It is separate from the company's Avandia site, which is about this newly approved drug for controlling type 2 diabetes.

What effect will Secretary Shalala's action have on these sites? Healthexchange CEO Victor Imbimbo says he welcomes it.

"That type of legislation is necessary," he says. "The institutions and companies go to great lengths to be precise and diligent in developing and executing clinical trials. But as we developed our site we spoke to consumers who were chronically or seriously ill and who were excellent candidates for the trials. While we knew there would be some confusion about what clinical trials were, their lack of knowledge was surprising."

But their biggest concerns were exactly what Secretary Shalala is seeking to address, Victor told me. It's certainly important to all of us for clinical trials to be as safe as possible. 


The American Diabetes Association originally published this article on its Web site as one of my “About the Internet” columns.


Update

What are the standards to which we should hold all clinical trials? Unfortunately, many people—even those in the medical profession—don't know or care. The double-blind placebo-controlled trial is one of the major scientific advances of the 20th century, with consequences of a magnitude greater than is generally understood. Dr. Steven Bratman writes clearly and fully on this important subject and authorizes me to make it available here. The URL is http://www.mendosa.com/bratman.htm .


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