Clarity, Communication Key to Informed Consent Efficiency

Layers of complexity can spark errors in informed consent documentation, slowing the process and even damaging clinical trials, says Lindsay McNair, MD, MPH, MSB, chief medical officer at WIRB-Copernicus Group in Princeton, N.J. Those engaged in informed consent policy and implementation should ensure the existence of clear descriptions of the eligible population and ought to […]

Ken Getz

Getz: Ideathon Winners Will Boost Clinical Trial Awareness

While a team calling itself C2: The Clinical Study Change Agent Collective from patient recruitment firm FCBVio was selected as the first “Inspiring Hope Ideathon” winner in a contest designed to spark creativity around raising awareness of clinical trials, program judges say they’ll connect the creators of the other project finalists and of several other […]

Carrie A. Hanger, an attorney with Smith Moore Leatherwood LLP

Sites Risk Heavy Fines Without Medicare Coverage Strategy

Clinical trial site leaders who lack a clear understanding of what is reimbursable under Medicare and Medicaid can face big fines and a big public relations black eye if they don’t develop a strong program, says Carrie A. Hanger, an attorney with Smith Moore Leatherwood LLP in Greensboro, N.C. While this tends to be a more common weakness […]

Dr. Marjorie Jenkins, MD, MEd, FACP, Director of Medical Initiatives and Scientific Engagement with the Office of Women’s Health at the FDA

FDA Launches New Efforts to Encourage Trial Participation Among Diverse Women

The U.S. Food and Drug Administration (FDA) will hold a series of webinars—bolstered by new resources that include white papers and a toolkit from the National Institutes of Health (NIH)—designed to encourage women across ethnic, economic, and age spectrums to participate in clinical trials. “You have to plan for diversity,” says Dr. Marjorie Jenkins, MD, […]

FDA Headquarters

FDA Challenges Industry to Improve Patient-Centric Clinical Trials

Talking to patients in a cursory way simply to check off that box is not what true patient-centric clinical trials are all about, according to John Whyte, Director of Professional Affairs and Stakeholder Engagement at the Food and Drug Administration (FDA). The agency wants to see evidence that the trial designers know exactly what they […]