Blogs

Battle lines being drawn among key healthcare constituencies, as discussions around new approaches to drug evaluation and decision-making heat up.

Agency leaders seek to build public trust in science and gain support for regulation.

The reporting of one man in Europe is changing accountability with compliance.

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.

But despite showing a tightening of focus on clinical trials and evidence, the annual report doesn’t paint the full picture.

Survey taken by pharma and CRO executives evaluates how effectively various programs convert RWD into usable data.

Survey taken by pharma and CRO executives evaluates attributes of large datasets.

Industry must take steps in preserving data for use after the war.

Aasma Shaukat, MD, MPH, study co-lead, professor of medicine, and director of outcomes research for the Division of Gastroenterology and Hepatology at New York University Langone Health discusses how sites have evolved since COVID-19.

ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.

Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”

Melika Davis, SVP of Global Clinical Operations at BeiGene, discusses her perspectives on patient access, diversity, and risk mitigation.

Tony Clapsis, SVP and General Manager, CVS Clinical Trial Services, reflects on industry’s progress.

Plan to keep new methods adopted during COVID in place.

Identifying careless responding to improve survey construction and results.

Survey among pharma and CRO executives evaluates current usage of RWD.

‘Independence’ the priority for the longstanding European Organization for Research and Treatment of Cancer, Winette van der Graaf tells Applied Clinical Trials in interview.

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.

Stress the importance of clinical studies today—and urge for formal approach to managing the pandemic and addressing specific public health needs more sustainably.

New survey will assess how pharma and biotech companies are incorporating patient engagement into their drug development organizations and operations.

Looking to the past reminds industry of great strides taken in clinical research for patients.

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.

Strategies for sustaining clinical operations during wartime.

Looking at the road ahead to properly utilizing digital technology in clinical trials.

Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.

Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.

Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.