Drugs

Ways to Overcome Cancer Trial Site Activation Bottlenecks: Research

A Friends of Cancer Research survey of eight drug companies with global oncology drug development programs determined that the U.S. excels at initial clinical trial site activation, but lags in scaling up site activation. The report says the first U.S. sites were activated a median of 124 days after final protocol approval, compared to 308 days for all sites outside the U.S. However, the U.S. required substantially longer than other regions to activate 75% of planned sites and to reach the first-patient-in.

After first-site activation, it says, U.S. trials required 309 days to activate 75% of planned sites, compared with 34-126 days across other regions. U.S. sites also required a median of 93 days to enroll the first patient, compared with 43-60 days in other regions. “These findings suggest that a primary challenge for U.S. trials is achieving efficient activation across a broad network of sites,” Friends of Cancer Research says.

The surveyed companies said the primary bottlenecks for U.S. trial start-up were prolonged budget negotiations, redundant/iterative local review processes, and site resource limitations. In particular, they said, continued reliance on local institutional review boards (IRBs) and independent committees for reviewing protocol amendments and other trial documentation introduces redundant, sequential steps that delay U.S. site activation.

The report says that potential opportunities to address the issue include broader and more consistent use of central IRBs and centralized amendment review, standardized contracting and budgeting approaches, parallel rather than sequential institutional reviews, and clearer expectations for site readiness.

“Examining trial implementation and operations will be essential to ensuring that innovative treatments continue to be studied and reach patients in the U.S.,” Friends of Cancer Research concludes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome