Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

ABSTRACT:

Background/aims

The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research

SUBMITTER: Perez R 

PROVIDER: S-EPMC5560478 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature