Clinical Researcher

The FDA has released final guidance on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” One relatively minor difference from the draft version actually represents a major step forward in statistical analyses for randomized controlled trials (RCTs).

Taken as a whole, in one way or another the pieces of this issue are all about not just the need for, but the inevitability of, ongoing change in the clinical research enterprise—not just change for the sake of change, but change for the better.

Although there are challenges and drawbacks to implementing artificial intelligence (AI) in clinical trials, it has potential benefits that make it a viable tool for the pharmaceutical industry.

Understanding the needs of your customers and getting them right the first time builds customer satisfaction and a sustainable business strategy. That seemingly simple objective is at the heart of a strong quality culture.

When organizations collaborate, sponsors can leverage unique expertise, unparalleled resources, and an established, stable infrastructure, including research, sites, donors, partnerships, and scientific and operational expertise.