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Orphan Drugs Continue to Struggle During Approval Process

Average development time for orphan drugs that were first-in-class new molecular entities (NMEs) and that won U.S. Food and Drug Administration (FDA) approval between 1999 and 2012 was 18% longer than the average journey for all new drugs, says a new report from the Tufts Center for the Study of Drug Development (CSDD). Orphan NME […]

Kendall A. Marcus, MD, Director of the Division of Dermatology and Dental Products with the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration

FDA Encourages More Patient Input to Inform Reported Outcomes

In real estate it’s location, location, location. In clinical trials? Try patient, patient, patient. “Early patient input is critical on the road to patient-focused outcome treatment,” Kendall A. Marcus, MD, director of the Division of Dermatology and Dental Products with the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, told […]

New Report Says 20% of Cancer Trials Fail Due to Insufficient Patient Enrollment

Obstacles Continue to Hinder Cancer Clinical Trial Enrollment

While many patients express a willingness to participate in a cancer-related clinical trial, “only a small fraction” end up enrolling due to “barriers that make participation difficult or even impossible,” says a new study. According to the report on “Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer” produced by the American Cancer Society […]

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All of Us Research Program Launching New Individualized Health Initiative

On May 6, the All of Us Research Program will begin national enrollment, inviting people ages 18 and older, regardless of health status, to join this momentous effort to advance individualized prevention, treatment, and care for people of all backgrounds. Part of the National Institutes of Health, All of Us is expected to be the […]

Ken Getz

Are You Ready for the “Course Correction” in Clinical Trials?

Buckle up, because the clinical trial industry is on the cusp of seismic change that will “have a huge and profound impact on all of you and the work that you do,” Kenneth Getz, MBA, director of sponsored research programs and a research associate professor at the Tufts Center for the Study of Drug Development, […]