By Robert Hand ([email protected])

The US Food and Drug Administration (FDA) in August proposed a new guideline asking the sponsors of clinical trials to submit annual development safety update reports (DSURs). The guideline, titled “E2F Development Safety Update Report,” is in draft form and describes the format, content, and timing of a DSUR. It specifies that a DSUR update the status of the clinical trial, summarise the sponsor’s understanding and management of identified and potential risks, describe new safety concerns that could affect the protection of trial subjects, and examine whether the information collected in the previous year accords with current knowledge of the product’s safety.

DSURs would be required for investigational drugs, including biologicals, with or without marketing approval, and whether or not the clinical trials are being conducted by commercial or non-commercial sponsors. A DSUR would have to be submitted within 60 days of the DSUR data lock-point, determined by the date of the sponsor’s first authorisation to conduct a clinical trial in any country (the “Development International Birth Date”).

The guideline instructs sponsors to focus on data from interventional trials. However, it also advises the inclusion of other findings that may have a bearing on the safety of trial subjects. Such information could include findings of non-clinical trials, as well as clinical trials conducted by the sponsor’s development partners and non-interventional or compassionate-use studies.

The FDA draft guideline matches one developed by the International Conference on Harmonisation (ICH).

Will DSURs create more work for the sponsors of clinical trials? Apparently not, at least in the long run. First, the guideline follows a standard format that has been developed for submission in the three ICH regulatory regions (the United States , the European Union, and Japan ). A report produced in accordance with the guideline could be submitted simultaneously in all three regions. Second, the DSUR would replace some reports that are currently required, such as the IND Annual Report. For already marketed products, some of the information required for the DSUR may be provided in the periodic safety update report (PSUR), on which the DSUR is patterned.

The draft guideline may be obtained online at www.regulations.gov or www.fda.gov/cber/guidelines.htm. The FDA has solicited comment on the draft. To be useful, comments should be submitted by 3 November 2008.