In a long-debated move, the NIH will no longer characterize basic experimental studies involving humans as clinical trials.

NIH updates clinical trial definition to exclude basic experimental studies involving humans from clinical trial requirements starting May 2026.

Gregory Wilding, PhD (Series Introduction) Professor Department of Biostatistics School of Public Health and Health Professions Director, CTSI BERD Core Michael LaMonte, PhD, MPH (Clinical Trials ...

A New York Times health reporter explains what clinical trials are, why they are important and how they can help inform us. Credit...Ricardo Tomás Supported by By Nina Agrawal Nina Agrawal is a health ...

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...

On 29 January 2026, NIH announced that basic experimental studies involving humans will no longer be subject to NIH Clinical ...

Carrie Madormo, RN, MPH, is a health writer. She has over a decade of experience as a registered nurse, practicing in a variety of fields, such as pediatrics, oncology, chronic pain, and public health ...

This workshop reviews the basics of Good Clinical Practice (GCP) and the recent updates that impact practice in an increasingly electronic environment. It will highlight the responsibilities the ...

Many times, when people think about joining clinical trials, getting a doctor’s referral is the first thing that comes to ...

Susan Vadaparampil, PhD, MPH, of Moffitt Cancer Center, concludes her conversation with The American Journal of Managed Care® at last month’s Institute for Value-Based Medicine ® event in Tampa, ...

Early-phase oncology trials carry substantial scientific and commercial risk in cancer drug development. Getting them right ...

In the Union Budget for FY27, the government announced plans to accredit more than 1,000 clinical trial sites to speed up drug development. Whether it works will depend on manpower and regulatory ...