New Ways to Recruit Trial Subjects
Applied Clinical Trials
To minimize time to market, sponsors must explore new subject recruitment techniques.
Clinical trials are a vital step toward bringing new drugs to market. U.S.-based clinical trial activities increased by 6% in 2001, the largest rise since 1990.1 But although pharmaceutical companies pay close attention to the science when designing their clinical trials, few consider how they will get enough subjects to participate. As a result, most trials are plagued by delays that can cost pharmaceutical companies millions of missed sales. Delays in getting a drug to market are estimated to cost companies around $1 million a day.2
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
