3,000 on-line trial reports needed pa, FDA claims

The US Food and Drug Administration estimates that about 3,000 clinical trials for drugs, including biotechnology agents, will need to be posted on-line under the new regulations coming into effect with the Food and Drug Amendments Act of 2007 (Marketletters passim). An additional 12,000 information submissions made on a voluntary basis are also expected, although this figure includes non-drug related trials, for example medical devices.

Health Data Management reports that the legal requirement will now be for registration information to be provided to the FDA's ClinicalTrials.gov web site within 21 days of the first subject being enrolled in a study. Any changes will have to be recorded within 30 days and results within a year of completion, except in certain specific instances.