Cancer Drugs Dominate Approval Landscape

In a dramatic upsurge since the 1980s, cancer drugs now account for more than one-fourth of all new drug approvals in the United States since 2010, up from 4% a few decades ago, according to a new analysis from the Tufts Center for the Study of Drug Development (CSDD). From 1980 through 2018, the U.S. […]

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FDA Issues Guidance on Placebo-Controlled Design in Hematologic, Oncology Trials

With the clear understanding that using a placebo in randomized controlled clinical trials of therapies to treat hematologic malignancy and oncologic disease for which there is known effective therapy is ethically unacceptable, sponsors should consider using a placebo-controlled design only in specific, narrow circumstances, the U.S. Food and Drug Administration (FDA) says in a new […]

Sponsors Want to Hear from Sites—With Evidence

Sites, especially smaller and newer ones, don’t like to challenge sponsors during a clinical trial, and that’s understandable, says Melissa Holbrook, MSN, NP, vice president for operations with Velocity Clinical Research. “Sites are not always comfortable pushing back, especially after they’ve opened a trial for enrollment,” she notes. It’s also unfortunate, she stresses. Frank, two-way […]

Is There a Compelling Business Case for CTMS?

Many clinical trial practices lose as much as 10% of potential revenue due to inaccurate, lost, or missing charges, says Noelle Gaskill, vice president for research operations with SignalPath. Clinical trial operations are “leaving money on the table” by failing to capture revenue—and part of the problem stems from relying on weak technology packages that […]

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Templates, Checklists Surprisingly Powerful Tools in Clinical Research

Templates and checklists might not sound like the most powerful tools in the arsenal of good clinical trial performance, but don’t tell that to Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, CSM, Chief Implementation and Operations Officer for IACT Health. Harnessed properly, such tools do nothing less than “free you up to do the job […]