The FDA issued a 49-page draft guidance on how industry should go about asking patients what’s most important to them about how they are dealing with their disease and its treatment, to help companies better develop new drugs.
The second in a series of four planned guidances on facilitating a systematic approach towards collecting and using patient and caregiver input, the draft goes into detail on various research methods and notes how those methods can help in the development of clinical outcome assessments and the generation of patient preference information.
Using real-world data (RWD) and real-world evidence (RWE) in clinical trials is growing in popularity among both industry and the FDA, but both groups agree that all stakeholders need to be on the same page when it comes to definitions and ways to measure results.
“There is a tremendous interest in making use of the vast amount of data that’s already been collected in healthcare systems to more efficiently generate evidence,” the FDA’s Robert Temple told participants at a joint FDA and Duke University workshop last week.
Sponsors recognize the advantages of using a single system to handle all trial operations, but progress from theory to practice has been slow, a new survey shows.
Software company Veeva Systems’ recent survey of clinical trial professionals about the benefits of unified clinical operations — single centralized technology systems that handle all operations tasks — points out the major problems created by using disconnected systems for individual functions.
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.