Honoring Our Promise: Clinical Trial Data Sharing

Clinical Trials Data Sharing Word CloudWhen people enroll in clinical trials to test new drugs, devices, or other interventions, they’re often informed that such research may not benefit them directly. But they’re also told what’s learned in those clinical trials may help others, both now and in the future. To honor these participants’ selfless commitment to advancing biomedical science, researchers have an ethical obligation to share the results of clinical trials in a swift and transparent manner.

But that’s not the only reason why sharing data from clinical trials is so important. Prompt dissemination of clinical trial results is essential for guiding future research. Furthermore, resources can be wasted and people may even stand to be harmed if the results of clinical trials are not fully disclosed in a timely manner. Without access to complete information about previous clinical trials—including data that are negative or inconclusive, researchers may launch similar studies that put participants at needless risk or expose them to ineffective interventions. And, if conclusions are distorted by failure to report results, incomplete knowledge can eventually make its way into clinical guidelines and, thereby, affect the care of a great many patients [1].

Continue reading

Formula for Innovation: People + Ideas + Time

Collage of scientists, clinical research, and science imagesIn these times of tight budgets and rapidly evolving science, we must consider new ways to invest biomedical research dollars to achieve maximum impact—to turn scientific discoveries into better health as swiftly as possible. We do this by thinking strategically about the areas of research that we support, as well as the process by which we fund that research.

Historically, most NIH-funded grants have been “project-based,” which means that their applications have clearly delineated aims for what will be accomplished during a defined project period. These research project grants typically last three to five years and vary in award amount. For example, the average annual direct cost of the R01 grant—the gold standard of NIH funding—was around $282,000 in FY 2013, with an average duration of about 4.3 years.

Continue reading

Helping Researchers Devastated by Superstorm Sandy

Last Friday, I and NIH Deputy Director for Extramural Research Dr. Sally Rockey visited the NYU Langone Medical Center in New York City. We were there to see what NIH could do to try to help the biomedical researchers whose work has been disrupted—and laboratories devastated—by Superstorm Sandy, which slammed into the Northeast coast about a month ago.

Photo of damage caused by Superstorm Sandy

The force of the water blew metal doors open and destroyed years worth of experiments.
Credit: Lori Donaghy

From what we saw during our visit, I can tell you the damage is truly appalling. The violent surge of water from the East River at 31st Street topped all predictions and came with great swiftness, bursting through concrete walls and blowing open iron doors.  The lab animal facility was quickly submerged, and thousands of valuable mice and rats were lost. Central facilities for electrical power and heating in an older building were severely damaged; this will take many months to repair since the flood also exposed vast amounts of asbestos.

We met with NYU leadership in a chilly conference room to learn of their 24/7 efforts to respond to this unprecedented disaster. Then, we toured some of the labs that are unusable because the infrastructure has been essentially obliterated. Dr. Rockey and I also met with faculty, staff, and postdocs in a town meeting and expressed our solidarity with this beleaguered community. We promised to use all available tools from NIH to help: altering submission deadlines for grant applications, allowing researchers to negotiate new specific aims, and extending training periods for trainees whose research projects have been seriously affected. Soon, NIH will issue an opportunity for NYU researchers who have lost precious equipment or supplies to apply for additional funding through Administrative Supplements.

My hat is off to NYU Langone’s Chief Scientific Officer Dr. Dafna Bar-Sagi and her colleagues for leading the recovery effort. They are engaged in a heroic endeavor that will extend over many months, possibly years, as they construct a new animal facility. While the road ahead is long, there is no doubt from what we saw on Friday that the scientists at NYU are determined and resilient.  All of us should do whatever we can to help this vital part of our nation’s biomedical research community during these terribly difficult circumstances.