Trial Stakeholders Advise White House on Emergency Research Infrastructure

Following a request for information by the White House’s Office of Science and Technology Policy (OSTP), a number of industry groups offered suggestions for priming the U.S. clinical research infrastructure to effectively respond to future public health emergencies. Read More

Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

Healthcare workers’ levels of stress rose to a new high of more than 40 percent in 2022, putting them at greater risk of health and work performance issues, according to the latest in a series of annual surveys. Read More

Industry Briefs

FDA Guidance Advises RCTs for Oncology Drugs Seeking Accelerated Approval

Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week. Read More

FDA Framework Will Explore DHTs in Regulatory Decision-Making

The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development. Read More

UK Proposes Sweeping Changes to Rules Governing Clinical Trials

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations, including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More