HHS, NIH Take Steps to Enhance Transparency, Public Access to Clinical Trial Results

Last week, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII (Clinical Trial Databases) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. The NIH also announced a proposal to apply the proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that all NIH-funded clinical trials be registered in ClinicalTrials.gov and that summary results be posted to the database in a timely matter. Both documents are open for a 90-day public comment period, and comments will be taken into consideration before final regulations and a final NIH Policy are issued.

ClinicalTrials gov

More Steps for Open Access

Jonathan Eisen, an evolutionary biologist at U.C. Davis Genome Center, has been named the first Academic Editor-in-Chief at the Public Library of Science (PLoS) journal PLoS Biology. He wrote an editorial published Tuesday on the PLoS Biology website that discusses his conversion and commitment to open-access publishing. His personal experience exemplifies what to me is the principle reason for open access [1]:

So there I was — a scientist and a taxpayer — desperate to read the results of work that I helped pay for and work that might give me more knowledge than possessed by our doctors. And yet either I could not get the papers or I had to pay to read them without knowing if they would be helpful.

Decisions in health and medicine frequently aren’t black and white. In the Internet age, more and more people are using the web to guide healthcare decision making. Allowing healthcare consumers and e-patients access to evidence from biomedical research studies will enable them to make more informed decisions about their healthcare. Open access is pivotal to that empowerment.

Elsevier’s Approaches to Public Access of Biomedical and Cancer Research

Elsevier, a leading publisher of over 400 medical and scientific journals serving more than 30 million scientists, students and health and information professionals worldwide, has initiated a beta test program called Patient Research. The program gives patients, family members and caregivers access to medical articles to help them understand their health issues.

Bill in Senate to Expand Public Access to Taxpayer-funded Research

The National Institutes of Health (NIH) is the world’s largest source of funding for biomedical research. Taxpayers provide more than $28 billion annually for the NIH [1], yet only about a third of the research studies are made publicly available in various repositories after a 12-month delay [2]. Lawmakers are trying to change this and the U.S. Senate is currently deliberating a bill that would require all research funded by the NIH to be freely available to the public within 12 months of publication.