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NIH’s new definition of a clinical trial.

“Some scientists hate NIH’s new definition of a clinical trial. Here's why ..

A new National Institutes of Health (NIH) policy aimed at boosting the rigor and transparency of clinical trials is triggering concerns among many behavioral scientists. ... NIH officials say they are still determining which behavioral studies will be defined as clinical trials.

NIH officials say they simply want to ensure that all clinical trials—including those testing drugs, medical devices, and behavioral interventions—meet recently bolstered standards for rigor and transparency. But Kanwisher and others say that the agency’s widening definition of clinical trials could sweep up a broad array of basic science studies, resulting in wasted resources and public confusion. “The massive amount of dysfunction and paperwork that will result from this decision boggles the mind” and will hobble basic research, Kanwisher says. To prevent that outcome, she and dozens of other researchers, along with several scientific societies, have flooded NIH with letters and emails expressing concern about the policy, which the agency announced last September but is only now implementing.

Read on...

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Companies Rush to Develop ‘Utterly Transformative’ Gene Therapies

The approval of gene therapy for leukemia, expected in the next few months, will open the door to a radically new class of cancer treatments.

Companies and universities are racing to develop these new therapies, which re-engineer and turbocharge millions of a patient’s own immune cells, turning them into cancer killers that researchers call a “living drug.” One of the big goals now is to get them to work for many other cancers, including those of the breast, prostate, ovary, lung and pancreas.

Researchers at the University of Texas MD Anderson Cancer Center in Houston are trying a completely different approach to engineering cells, one that they hope might eventually yield an “off the shelf” treatment that would not have to be tailored to each individual patient and that might be less expensive.

Instead of using T cells, the team uses natural killer cells, another component of the immune system, one that has a powerful ability to fight anything it recognizes as foreign. Instead of extracting the cells from patients, the researchers, Dr. Katy Rezvani and Dr. Elizabeth Shpall, remove the natural killers from samples of umbilical-cord blood donated by women who have just given birth.

They use natural killer cells because T cells from one person cannot be safely given to another, lest they attack the host’s tissue, causing graft-versus-host disease, which can be fatal. Natural killer cells do not cause that deadly reaction, so it is safe to use such cells from a newborn’s cord blood to treat patients.

Read on...

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