During the past several years, CISCRP has strongly advocated for lay-language clinical trial results summaries based on feedback from patients. Study volunteers deserve to receive the results of their clinical trials directly in language that is clear and understandable. CISCRP needs your help to advocate for lay language summaries of trial results for patients.
Please read the following letter to FDA Commissioner Dr. Margaret Hamburg and fill out the form below to show your support and bring us one step closer!
Download a PDF of the letter here.
In November, the Department of Health and Human Services (DHHS) proposed a new rule that would expand public sharing of summary data from clinical trials for applicable products regulated by the FDA. The draft policy expands reporting requirements established in 2007 under Title VIII of the Food and Drug Administration Amendments Act to include publicly-funded drug and device studies. However, the new rule lacks a more meaningful consideration by US regulators to share clinical trial results with study volunteers in non-technical, lay language. We are asking the FDA to publicly support fulfilling this obligation and to do more to ensure that this happens.
“We applaud the proposed rule but it is disappointing, and I anticipate patients, the public and professionals will submit comments in the coming months in response,” said Ken Getz, CISCRP’s founder and board chair. “HHS and NIH did not address the central issue: dissemination of lay-language clinical trial results summaries for patients and the public. The proposed rule does not go far enough in recognizing that research professionals have entered a binding social contract with study volunteers that is met only when central trial results are accessible and communicated appropriately to these volunteers and the public.”