Comments to PCORI on COI Policy

Association of Clinical Research Organizations:

Comments before the Patient Centered Outcomes Research Institute Board on July 18, 2011

Thank you for the opportunity to comment today. I am John Lewis, vice president of public affairs with the Association of Clinical Research Organizations.  ACRO members conduct the majority of clinical trials globally. Last year, for instance, our members conducted approximately 800 post-approval studies in the areas like drug safety, health outcomes and comparative effectiveness, relying both on data analysis and new trials.

While we have several concerns with the operations of PCORI to date, I will focus my comments today on the development of a conflicts of interest policy for third parties.  We noted with interest the discussion presented by PCORI’s Finance and Administration Committee during the May meeting in New York.  We appreciate this opportunity to provide the views of clinical research organizations in support of a conflicts of interest policy for third parties that is consistent with the disclosure standards in PCORI’s authorizing statute.

First, we must stress that these conflict of interest policies must be developed in a transparent manner and be exposed for a public comment period of 45-60 days.

Second, for the following reasons, we strongly recommend that the statutory disclosure standards be closely adhered to rather than NIH-like policies. READ FULL ARTICLE


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