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Vital Signs

Making clinical trials a lot less of a trial

By Amos Esty

Dartmouth-Hitchcock's Clinical Trials Office has a regional coordination program that makes its services available far, far beyond the bounds of the Lebanon campus.

At any given time, DH physicians, scientists, and administrators are involved in hundreds of clinical trials. Their efforts are essential to developing new treatments, but starting and carrying out a trial is not an easy undertaking. A new initiative is now making that process a little less difficult.

Devices: Clinical trials are research studies that involve humans. They are most often carried out to test the effectiveness of drugs, medical devices, or surgical procedures.

In January 2010, DH, in collaboration with Dartmouth College and DMS, created a central Clinical Trials Office (CTO) to help investigators with such studies. More recently, the CTO rolled out a unique regional coordination program dedicated to allowing all DH sites to participate in clinical research.

Matthew Hodgson, the interim director of the CTO, says the office relieves investigators of some of the administrative responsibilities associated with a study, allowing them to focus their efforts on the research. The regulations governing clinical trials are extensive and constantly in flux, making it hard for an investigator to stay on top of the changes and meet all the complex requirements.

Christopher O'Keefe is the administrative director of the psychopharmacology research group, which typically has four or five trials ongoing at any time, usually related either to schizophrenia or alcohol dependence.

Trials: He wishes the CTO had been around 12 years ago when he began working on clinical trials. "A lot of the support that the CTO provides in terms of infrastructure we kind of had to learn on our own," he says. "Physicians and their staff want to do the investigative part. They don't know about the regulations."

The regional program, which Hodgson leads, is now making it easier for researchers to enroll patients in studies—and is giving patients from throughout northern New England easier access to such studies.

The regional program is making it easier to enroll patients in studies.

Issue: "Patient recruitment is always an issue," says Dr. Corey Siegel, a specialist in gastrointestinal disorders. He has worked with the CTO on studies related to Crohn's disease and ulcerative colitis and is now in the early stages of a genetics study examining family members of patients with these diseases.

Siegel points out that studies often have narrow criteria for subjects, so many patients may need to be screened for every one who can be enrolled. "It's a lot of time and effort to find the right patients who are both appropriate for the study and also are interested in being part of a clinical trial," he says. So the CTO's regional effort "clearly expands our potential pool of patients dramatically."

The regional program also makes the CTO's services—including help with contracts, budgets, monitoring, Medicare coverage analysis, regulations, and training—available at all DH sites, not just the main campus in Lebanon, N.H.

Effort: Siegel believes that the CTO's effort to reach out to other DH sites will benefit everyone involved in clinical trials. Not only will it help researchers enroll enough subjects, he says, but they will now also be able to "offer these exciting new therapies to [more] patients."


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