Beginning chart reviews before initiating a site can generate a list of prequalified candidates for outreach — and give sponsors the chance to examine the study’s inclusion and exclusion criteria, and their potential to cause enrollment issues, according to experts during two WCG webinars on acceptable methods for sites and sponsors, and best recruitment practices. Read More

In February 2019, the FDA will require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent. Read More

At the annual SCOPE conference in Orlando, Fla., clinical trials experts agreed that the traditional relationship between contract research organizations (CROs) and sponsors is evolving, alongside accelerated pursuits in big data and patient centricity — with more CROs expected to share in the risks of drug development as more of a partner than a vendor. Read More

With a multitude of sensors, wearables and mobile devices becoming available for use in clinical trials, sponsors should conduct systematic comparisons before designing protocols, according to experts at the annual SCOPE conference, who presented the work they’ve done to demonstrate the value of using digital monitoring in their studies, as well as the obstacles they encountered. Read More

At a symposium marking the Clinical Trials Transformation Initiative’s 10th anniversary, industry and regulatory discussed the progress made by its Quality by Design initiative and the additional work needed to encourage the research industry to be more focused on trial quality and efficiency. Read More

The FDA has updated its guidance to institutional review boards and clinical investigators clearly allowing reimbursements to patients in clinical trials for lodging and travel. Read More

Nearly 14 percent of all drugs in clinical trials eventually win approval from the FDA — a much higher percentage than previously thought, according to a new study from the MIT Sloan School of Management. Read More

With uncertainly about the impact of Brexit, and concerns about quality in India and China, drug development companies are looking to other markets to conduct clinical trials. Read More

Companies reported 28 percent longer clinical trial cycle times and startup processes for new sites compared to repeat sites, according to a study conducted by the Tufts Center for the Study for Drug Development (Tufts CSDD) and goBalto. Read More

International patent and U.S. courts agencies are once again setting up to possibly decide the course of clinical research, genomics and personalized drug development, this time with CRISPR. Read More