More MS news articles for December 1999

Patients to enroll in drug trials via Web site

Russ Colchamiro

© 1999 Medical PressCorps News Service

Information about ongoing clinical trials can be difficult to find.

Similarly, it can be difficult for pharmaceutical manufacturers to find the people they need to test the safety and efficacy of medications, under carefully controlled conditions, both before and after marketing.

A new Web site will soon be up and running where people who want to be in clinical trials for as-yet-to-be-approved prescription drugs can register. The site, called FreeDrugTrials.com (http://www.FreeDrugTrials.com), based in Nanuet, N.Y., will launch early next year.

Patients sign up for the service by first filling out a standardized medical screening questionnaire provided by the company. They must then undergo a complete physical examination. Once patients receive medical clearance, they are then matched to the drug trial most suited to their physical condition.

Patients may be excluded from one drug trial, but accepted for another. For example, a patient may be excluded who is currently taking medications or suffers from a pre existing medical condition.

"Using the power of the Internet, we believe that we can reach across geographic boundaries to qualify and recruit patients for drug trials," said John Spallanzani, president and chief executive officer of FreeDrugTrials.com.

The Web site recruitment service will target patients for any or all four phases of clinical trials. Phase I trials are designed to study the drug's toxicity. Phase II trials seek to identify potential therapeutic doses. Phase III trials are large-scale trials testing for the drug's efficacy and the last phase prior to the drug's approval by the Food and Drug Administration. Phase IV trials are post-marketing studies designed to provide additional information on the existing drugs.

Patients will be compensated for their participation in a drug trial -- either through FreeDrugTrials.com or the drug manufacturer sponsoring the trial. Spallanzani declined to quote an exact amount.

Clinical trials will be listed on the Web site by category of illness. However, not all trials may be conveniently located to each patient. For example, Spallanzani explained that if a patient has been accepted for an asthma trial on the East Coast but lives on the West Coast, his or her name will be retained -- with the patient's permission -- in the company's database. If a newer trial located near the patient's home is scheduled, that patient would then be notified of the new study.

Spallanzani said that the Web site service was designed in response to drug manufacturers' need for patients willing to participate in new drug trials.

"There are a larger number of drugs coming to market sooner, so the needs of the researchers to have available patients is huge," said Dr. Joseph Balsamo, chief medical officer of FreeDrugTrials.com.

"They're trying to use a bigger net to recruit patients," said

Charles Daniels, chief of pharmacy at the National Institutes of Health Clinical Center in Bethesda, Md.

Spallanzani said www.FreeDrugTrials.com will launch by the end of the first quarter of 2000, if not before.

December 14, 1999