Study Gives Big Drug Makers Positive Trial Transparency Report Card

Most drug manufactures are doing a better job clearing away the smoke and providing better clinical trial transparency compared to 2015, according to a new survey on the reporting of results from trials that was sponsored by Bioethics International. Sanofi and Johnson & Johnson topped the list, both with 100% scores. “Among large pharmaceutical companies […]

Jonathan Goldsmith, MD, Associate Director of the Rare Disease Program of the Center for Drug Evaluation and Research at FDA

Flexible Endpoints Key to Successful Rare Disease Drug Trials

“What’s clinically meaningful to patients?” Jonathan Goldsmith, MD, associate director of the Rare Disease Program of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) asked the attendees of the FDA/CMS Summit in Washington, D.C. this week. When developing a clinical trial for a rare disease, Goldsmith encouraged […]

Panelists Discuss Patient-Reported Outcomes at FDA/CMS Siummit in Washington, DC

Patient-Reported Outcomes Becoming More Central to Trials

Fueled by new technologies and a growing commitment to patient-centric trials, patient-reported outcomes (PROs) are becoming increasingly important in the conduct of successful clinical trials. That’s the ground-level assessment of experts at the FDA/CMS Summit held this week in Washington, D.C. “We’ve been talking [about PRO] for 20 years, but I think technology is pushing […]

Marcus Stone, PhD, CEO, Spine Institute of Louisiana Foundation

Flawed Trial Negotiations Can Catch Site Newcomers Off-Guard

Study site leaders who are new to the business of conducting clinical trials are sometimes “naïve” and hesitant to ask probing questions as they work with sponsors to define study parameters at the outset, says Marcus Stone, PhD, CEO of the Spine Institute of Louisiana Foundation. “First, there is some fear of losing the business,” […]

Nicki Norris, MBA, CEO of Symphony Clinical Research

Offering Home Clinical Trial Visits Can Boost Patient Retention Rates

Sites looking to improve patient recruitment and retention might want to consider offering some home cooking, says Nicki Norris, MBA, the CEO of Symphony Clinical Research. Too often, recruiters and other site personnel forget patients have busy lives. Participating in a trial, as important as it may be, is only one of the items on […]