Diversity & Inclusion

Parexel's CEO Peyton Howell and India boss Sanjay Vyas talk to Scrip about the value of clinical trial diversity, AI pilots underway and opportunities for India amid geopolitical rumblings, as well as the need for standardized regulatory approaches to enhance sponsor interest.

A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.

A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.

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

Draft guidance recommendations on setting enrollment goals lead PhRMA and BIO to seek assurances of FDA flexibility absent reliable disease prevalence data.

Industry organizations argued feedback should be expected and object to draft guidance language suggesting it may be optional.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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.