Diversity & Inclusion

Draft guidance recommendations on setting enrollment goals lead PhRMA and BIO to seek assurances of FDA flexibility absent reliable disease prevalence data.

Industry organizations argued feedback should be expected and object to draft guidance language suggesting it may be optional. The agency also should apply waiver criteria flexibly and address potential consequences if enrollment goals are not met, stakeholders say.

As efforts to improve diversity in clinical trials gain momentum globally, the Pink Sheet asked regulators in the UK, the EU, Canada, Australia and Japan about their efforts to support representative enrolment. 

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.

The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity, questions about approving a new drug that would be used with a standard of care regimen that is off-label, and the agency beginning to schedule fully in-person advisory committee meetings.

The US FDA has published a discussion paper as part of an effort to ensure all patients have timely access to safe and effective medical devices. The agency says the paper fits into a larger strategy of promoting health equity and is seeking public comment on the initiative.

A push for government-driven accountability in clinical trial diversity is coming from a right of center figure, but could it nudge the FDA to be tougher on industry? The Pink Sheet spoke with Jerome Adams about his more than 30 years of work on the topic.

A study suggests industry groups like PhRMA could use more of their influence to hold members accountable on trial diversity policies.