Medicare national coverage determination for Alzheimer’s drugs has been a ‘game changer’ in terms of motivating industry to boost diversity in clinical studies in the disease, trial expert says.
Although Alzheimer’s stakeholders are dismayed by the treatment access restrictions imposed by the Medicare national coverage determination last spring, the policy has also jumpstarted improvements in clinical trials for Alzheimer’s drugs in an important way, according to Global Alzheimer’s Platform Foundation president John Dwyer.
The Centers for Medicare and Medicaid Services cited a lack of diversity in the pivotal clinical studies on Biogen,...
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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 agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
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 agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.
An FDA official said the agency is considering allowing MIDD meeting requests to be submitted more often, but must have a plan to deal with the likely increased demand.
