Clinical data management plans aren’t mentioned in FDA regulations, but don’t be fooled – they’re a key ingredient in winning product approval. So don’t just shrug them off, says a top agency official.
“Please don’t say ‘It’s not in the regulations, I don’t need to do it,’ because at the end of the day, if you don’t have that good data, your product is not going to be approved,” Cynthia Kleppinger, CDER’s senior medical officer, cautioned last week at a joint FDA-MHRA workshop on data integrity in global clinical trials.
The FDA released new guidance last week on how researchers can comply with both agency regulations and pending Common Rule revisions that protect human subjects in clinical trials.
The guidance focuses on requirements for informed consent, expedited review procedures and IRB continuing review. It says new requirements for informed consent documents in the revised Common Rule — the baseline body of regulations across federal departments and agencies for human subjects in clinical research — don’t conflict with any FDA regulations. But the agency says IRBs still have to comply with its regulations for expedited and continuing reviews.
HHS issued a proposed rule that would delay its revisions to the Common Rule for another six months and opened up discussion on the permitting of three burden-reducing provisions in the 2018 requirements for regulated entities. Read More
The FDA released two final guidance documents related to next-generation sequencing (NGS) and one draft guidance on investigational in vitro diagnostics (IVDs) in oncology trials. All three documents offer test developer recommendations for a more efficient path to market. Read More