Twitter Chat

Experts Debate Moving Patient Centricity from Concept to Reality

So-called patient-centric clinical trials are key to broadening participation, most experts agree. However, it begins to get a little dicey as soon as the term is lifted off the dictionary definition page and placed in the real world. Clinical trial leaders from across the spectrum discussed the importance of getting it done right during an […]

Dr. Meagan Vaughn, PhD, RAC, Research Scientist, Rho

Patients Face New Pressures in Gene Therapy Clinical Trials

While many gene therapy clinical trials appear to be on the cusp of generating some game-changing healthcare innovations, patients are on a steep learning curve navigating the new landscape, says Dr. Meagan Vaughn, PhD, RAC, a research scientist with Rho. “The pace of development is exponential right now in terms of how fast things are […]

Renata Yong, BPharm, Global Project Manager and Senior Medical Services Associate, George Clinical

Are You Prepared to Conduct a Surgical Placebo-Controlled Trial?

Although they offer several benefits when conducted in the right situation, surgical placebo-controlled trials pose ethical and safety challenges in terms of enrolling patients and finding the right professionals to conduct the trial, says Renata Yong, BPharm, a global project manager and senior medical services associate with George Clinical, a contract research organization based in […]

Janet Woodcock

FDA Pushes Sponsors to Expand Treatment Access After Successful Trials

A trio of heavy-hitters at the U.S. Food and Drug Administration (FDA) made a pitch for sponsors to think bigger when it comes to expanded access (EA) to treatment for patients after trials in a recent joint statement. “For more than 30 years, the FDA has supported patients’ access to investigational medical products for treatment, […]

Jason Methia, Veeva Systems

Empowering Sites to Ease the Administrative Burden of Clinical Trials

PAID MESSAGE Jason Methia, VP, Site Strategy, Veeva Systems Scientific innovation in the life sciences industry has accelerated at a rapid pace – the FDA’s Center for Drug Evaluation and Research (CDER) approved 59 novel drugs in 2018, compared to 46 approvals in 2017 and 22 in 2016.[1] While a major victory for patients, this […]