Dr. Scott Gottlieb, FDA Commissioner of Food and Drugs

FDA’s Gottlieb Pushes Use of Real-World Evidence in Clinical Trials

New U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb continued his roadshow promoting use of real-world evidence at a National Academy of Sciences event earlier this week. Turning to clinical trials, he said, “To enable greater adoption of [real-world evidence] in clinical and regulatory decisions, [FDA] will need to work with the healthcare system […]

Linda Sullivan, Cofounder and President, Metrics Champion Consortium

Snafus Continue to Plague Clinical Site Payment Process

Sponsors and sites continue to misunderstand where the clinical site payment process breaks down, and that’s not good news for anyone, says Linda Sullivan, cofounder and president of Metrics Champion Consortium (MCC). Clearly, there are “divergent views on how well the site payment process is working,” she says. “Sponsors are competing for the ‘cream of […]

Nora Volkow, MD, Director of the National Institute on Drug Abuse

Can Clinical Trials Help Stem the Opioid Overdose Epidemic?

Opioid overdose deaths have quadrupled in the U.S. in the past 18 years, according to the Centers for Disease Control and Prevention (CDC). Nearly 200,000 Americans have died as a result. Calling it a public health crisis, Ohio Senator Rob Portman called on federal authorities to step up and help confront it. “The [Food and […]

Kirsten Messmer, PhD, Regulatory Affairs Specialist, PPD

Gene Therapy Clinical Trials Pose Unique Challenges, Opportunities

While they are on the leading edge of clinical trial innovation, researchers conducting gene therapy trials contend with a myriad of international regulations and sometimes wary patients, said experts at a RAPS (Regulatory Affairs Professionals Society) conference session on September 12. It’s critical to understand the unique regulations enforced by different nations, said Kirsten Messmer, […]

FDA Logo

FDA Offers Patient-Reported Oncology Study Outcome Strategies

The U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE) Patient-Focused Drug Development Program fosters collaboration between FDA Centers and external stakeholders involved in patient outcomes research in cancer populations. The OCE’s overarching goal is to identify rigorous methods to assess the patient experience that will complement existing survival and tumor information, to […]