FDA plans changes to drug clinical trials: report
Posted on: Wednesday, 21 June 2006, 01:28 CDT
NEW YORK (Reuters) - U.S. regulators are re-evaluating clinical trials for medicines and plan changes that include a proposal to force drugmakers to promptly inform them if companies believe a researcher has committed fraud during a study, a newspaper reported on Wednesday.
The Food and Drug Administration is expected to launch an effort to standardize the forms used to collect information in studies and adjust the rules on how patients access experimental treatments, The Wall Street Journal said.
The FDA also will seek to clarify which adverse events in trials have to be reported to review boards that monitor studies to protect patients, the newspaper said.
FDA Deputy Commissioner Janet Woodcock will discuss the initiative on Wednesday at an industry conference, the newspaper said.
Source: REUTERS
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