Study Results should be given to participants.

Discussion in 'General Health & Wellness' started by gapsych, Dec 8, 2008.

  1. gapsych

    gapsych New Member

    I am also posting this on the health board.


    By Rita Rubin, USA TODAY

    When patients enroll in clinical trials, they do so with the knowledge that their own health might not benefit and could even be compromised. So the least researchers could do is reveal the results to them, a study concludes today.

    When a clinical trial ends, "there's usually not much additional effort done to reach out to participants and inform them (of the results) in a timely manner," lead author Ray Dorsey says. In fact, he says, participants usually don't even learn if they were taking the study drug or a placebo or comparator drug, information that could impact their own care.

    Dorsey, a University of Rochester (N.Y.) Medical Center neurology instructor, says it's ironic that drug companies are obligated to inform investors of clinical trial results, but researchers aren't obligated to inform participants.

    Dorsey and his co-authors told patients the results of a trial of a drug for Huntington's disease that found no benefit. They sent out a news release immediately after one was sent by the drug company that sponsored the trial. Then, staff members from the study sites called each participant. Finally, scientists held a conference call for participants and their caregivers two weeks after the results were released.

    Dorsey and his collaborators then surveyed the 217 participants about how they preferred to learn the research findings. Of the 114 respondents, nine out of 10 reported high or complete satisfaction with the phone call, and eight out of 10 with the conference call. But half reported low satisfaction with the drug company's news release.

    "Why isn't this standard?" Dorsey says of efforts to inform participants of study results. "I suspect it's just not a priority."

    It should be, says Conrad Fernandez, a pediatric oncologist at Dalhousie University in Halifax, Nova Scotia, who has surveyed researchers about why they don't inform patients of results.

    "We have a moral obligation to offer research results to participants," Fernandez says. "It needs to be done in a very carefully planned way."

    Ann Partridge, a Harvard breast cancer specialist who also has studied the question, notes that "not all trials are the same. Not all patients are the same." Partridge says she does offer to tell participants trial results: "Many are interested. Many are."