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Simpler Language, More Access to Results Sought for Clinical-Trial Volunteers



Pressure is growing on researchers to do a better job of communicating the results of clinical trials to the volunteers who participated.
As WSJ’s Informed Patient reports, groups like the Michael J. Fox Foundation for Parkinson’s Research are stepping up programs to help match patients to clinical trials.
Meanwhile, new FDA regulations that went into effect last month require that trial results be included in the federal ClinicalTrials.gov website after studies are completed. A number of summaries are already posted on the site, but they tend to be technical and aimed primarily at experts.
Deborah Zarin, director of ClinicalTrials.gov, tells the Health Blog that the Department of Health and Human Services is now considering whether consumer summaries can be developed in a way that is “non-promotional, complete and accurate.” Zarin adds that ultimately ClinicalTrials.gov will have to depend on industry and research sponsors to provide such information, “and no amount of regulation will get us to the point of it being part of the professional culture” to provide such summaries for lay readers.
According to a report published in the March issue of Expert Review in Clinical Pharmacology, preparing lay studies is feasible and generally easy to do. However, while most study volunteers are extremely receptive to receiving clinical trial results, most of them never do.
For the report, The Center for Information & Study on Clinical Research Participationand Pfizer’s Center for Discovery and Development Sciences translated technical clinical results of two Pfizer drugs into lay-language summaries, and added extra touches like sending thank-you cards to volunteers and updating them on the progress of reporting the results.
Volunteers appreciated the thanks and the updates. And a majority felt they understood the results of their trial very well or somewhat well after reviewing the lay summaries.
“People who agree to participate in clinical research want to know that their involvement informed medical knowledge about disease and how to treat it,” says lead authorKenneth Getz, an assistant professor at the Tufts University Center for the Study of Drug Development. He also heads the nonprofit CISCRP and owns CenterWatch, a for-profit publisher of information and data used by clinical research professionals.
In addition to helping patients search for clinical trials through its website or with a call to 1-877-MED HERO, CISCRP creates easy-to-understand results for certain trials.
Deb Faculak, a 62-year-old interior designer with Parkinson’s, enrolled in a trial she found through the Fox foundation’s Fox Trial Finder studying the effectiveness of a drug to treat uncontrollable tremors that can be a side effect of Levodopa, the primary treatment for Parkinson’s.
Her participation consisted of eight visits of about two hours each to Henry Ford West Bloomfield Hospital in Michigan, and she kept a diary of her symptoms. She doesn’t know which arm of the study she was in, but she is convinced she received the drug rather than a placebo and is eager to learn about the results and participate in future research.
“I was happy to be a guinea pig,” says Ms. Faculak. “The only way these drugs are going to be approved is to go through these trials, and if we don’t do it, who will?”

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