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Improving Clinical Trials Through Thoughtful Collaboration

While clinical trials can lead to many medical breakthroughs, they’re often weighed down by inefficiency and red tape. To fix the system, we need to reach across fields.

Many have called for major improvements in clinical trials that can accelerate the delivery of life-changing treatments to patients, yet randomized clinical trials continue to increase in cost and complexity, and questions of quality remain. Why is it so difficult to right the ship? Improving any single process among the hundreds involved in designing and conducting a clinical trial is unlikely to transform the overall system, nor can changes by just one stakeholder move the needle.

A systematic, evidence-based approach to addressing issues of efficiency and quality in clinical trials — one that includes participants from across the clinical trials enterprise as equal partners — is the method needed to achieve widespread, measurable improvements in clinical trials.


NIH to limit the amount of grant money a scientist can receive

US agency creates point system to address imbalance in distribution of research funds.

For the first time, the US National Institutes of Health (NIH) will restrict the amount of funding that an individual scientist can hold at any one time, on the basis of a point system. The move, announced on 2 May, is part of an ongoing effort to make obtaining grants easier for early- and mid-career scientists, who face much tougher odds than their more-experienced colleagues.

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Scientists seek early signs of autism

Biomarkers could aid diagnosis and lead to strategies for treatment

Soon after systems biologist Juergen Hahn published a paper describing a way to predict whether a child has autism from a blood sample, the notes from parents began arriving. “I have a bunch of parents writing me now who want to test their kids,” says Hahn, of Rensselaer Polytechnic Institute in Troy, N.Y. “I can’t do that.”

That’s because despite their promise, his group’s results, reported March 16 in PLOS Computational Biology, are preliminary — nowhere close to a debut in a clinical setting. The test will need to be confirmed and repeated in different children before it can be used to help diagnose autism. Still, the work of Hahn and colleagues, along with other recent papers, illustrates how the hunt for a concrete biological signature of autism, a biomarker, is gaining speed.

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NIH achieves milestone to accelerate multisite clinical studies

CTSA Program paves way for nationwide single IRB model.

Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

"This milestone is a giant step toward a nationwide model for greater efficiency in IRB review..."

Christopher P. Austin, M.D., Director, NCATS

The National Institutes of Health is leading policy and programmatic initiatives to streamline this overly cumbersome process. NIH's National Center for Advancing Translational Sciences (NCATS) announced today that all Clinical and Translational Science Awards (CTSA) Program sites have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement.

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Media Contact:

Michelle Maclay, Communications Director