FDA plans changes to drug clinical trials: report

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.