• A lack of standards from the Office of the U.S. Global Aids Coordinator (OGAC) is hampering the assessment of the President's Emergency Plan for AIDS Relief (PEPFAR) as partner-countries assume more responsibility for AIDS treatment programs within their borders, according to a report from the Government Accountability Office (GAO). Fully functioning monitoring and evaluation (M&E) systems are critical for tracking results and ensuring the effectiveness of the treatment programs, the GAO said, but OGAC hasn't established minimum standards, including data completeness and timeliness, for those systems. The report recommended OGAC develop a method to better account for PEPFAR's contributions to partner-country treatment programs, establish a common set of indicators to measure the results of treatment program quality improvement efforts and create minimum standards for data generated by partner-countries' M&E systems.

• With an eye on streamlining the review of clinical trials with low biosafety risks, the National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid molecules. Under the proposal, as long as an initial human study of certain human gene transfers is approved by a registered institutional biosafety committee (IBC), subsequent trials would not require IBC review and approval. However, the first study must establish the safety of the proposed dose of the vector and transgene in a comparable population. Subsequent trials must be conducted in the same country as the initial study to control for potential variability in infectious disease backgrounds of the subjects. Comments on the revision are due by June 12.

• In finalizing its 2011 draft guidance on "Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets," the FDA clarified several sections, including the linkage and pooling of data from different sources. The final guidance, released Tuesday, gives recommendations for documenting the design, analysis and results of the studies to optimize the FDA's review of protocols and final reports.