a placemarker…

Posted on Friday 31 January 2014

Jan 30, 2014

Under the agreement, the "Yale Open Data Access Project," will independently review and make final decisions regarding all requests for information on the company’s drug clinical trials, including anonymous patient data. Johnson & Johnson has selected the Yale School of Medicine to review requests from investigators and physicians looking for access to clinical trial data involving the diversified healthcare company’s pharmaceuticals.

The action comes amid growing pressure from outside scientists for access to raw data from clinical trials, reflecting general concerns that too many studies cannot be independently confirmed and may well be wrong. J&J, which sells drugs including blood thinner Xarelto and prostate cancer treatment Zytiga, said it is in the process of determining how best to share trial data from its other two areas of operation: medical devices and consumer products. "This is a multi-year effort on our part to try to contribute to advancing medical knowledge and science," Joanne Waldstreicher, J&J’s chief medical officer, said in a telephone interview.

Others drugmakers have made similar moves. Britain’s GlaxoSmithkline Plc has set up an online system to provide researchers with access to anonymous patient-level data about its medicines. Pfizer Inc Plc has set up an online system to provide researchers with access to anonymous patient-level data about its medicines.  said in December it would broaden access to information from its clinical trials to independent researchers and to patients who take part in the studies. Pfizer also set up an independent review panel of academic scientists to decide which researcher requests it would answer.
Yale University Open Data Access [YODA] Project

Each day, patients and their physicians make treatment decisions with access to only a fraction of the relevant clinical research data. Many clinical studies, including randomized clinical trials, are never published in the biomedical literature. The Yale University Open Data Access project has developed a model to facilitate access to patient-level clinical research data to promote wider availability of clinical trial data and independent analysis by external investigators.

The YODA Project model provides a means for rigorous and objective evaluation of clinical trial data to ensure that patients and physicians possess all necessary information about a drug or device when making treatment decisions. This process includes both coordinating independent examinations of all relevant product data by two separate qualified research groups and making all patient-level clinical research data available for analysis by other external investigators. The model is designed to provide industry with confidence that the analyses will be scientifically rigorous, objective and fair.

Of note, several features of the model are specifically focused on promoting transparency and protecting against industry influence:
  • Any company engaging in the model must provide all relevant product data
  • Two independent research groups, selected after a competitive application process, systematically review and analyze all relevant product data
  • An independent Steering Committee, including leaders in the field of clinical research and biomedical ethics, advise the YODA project team
  • A Clinical Advisory Committee, including leaders in the clinical practice that uses the product under evaluation, advise the project
  • Project leadership are committed to transparency, publication, and making the data publicly available…
Well, there’s a lot of creativity going into this business of Data Transparency. It’s hard to follow what actually happens in the YODA model, and after a couple of readings, I decided to table it and return with a clear head. I think most of us are concerned that there’s a trick in the mix, and we’ve come by that fear honestly. Reading through the plans proposed so far by GSK, Pfizer, now J&J, they seem to have a concern we don’t really care about – competitors messing around with their data. We heard that line in the now legendary foot-in-mouth performance by AbbVie’s lawyer, Neal Parker. I still find it ironic that they want us to trust them [hardly likely], but they don’t trust us, and they absolutely don’t trust each other. I post J&J’s proposal here as a placemarker for a later deeper look at these various plans. From my vantage, the ball is still in their court…
    February 1, 2014 | 10:01 PM

    And that comment, I believe, would be spam.

    February 1, 2014 | 10:07 PM


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