A snapshot of translational research funded by the National Institutes of Health (NIH): A case study using behavioral and social science research awards and Clinical and Translational Science Awards funded publications.

The translation of biomedical research from basic knowledge to application has been a priority at the National Institute of Health (NIH) for many years. Tracking the progress of scientific research and knowledge through the translational process is difficult due to variation in the definition of translational research as well as the identification of benchmarks for the spread and application of biomedical research; quantitatively tracking this process is even more difficult. Using a simple and reproducible method to assess whether publications are translational, we examined NIH R01 behavioral and social science research (BSSR) awards funded between 2008 and 2014 to determine whether there are differences in the percent of translational research publications produced by basic and applied research awards. We also assessed the percent of translational research publications produced by the Clinical and Translational Science Awards (CTSA) program to evaluate whether targeted translational research awards result in increased translational research. We found that 3.9% of publications produced by basic research awards were translational; that the percent of translational research publications produced by applied research awards is approximately double that of basic research awards (7.4%); and that targeted translational research awards from the CTSA program produced the highest percentage of translational research publications (13.4%). In addition, we assessed differences in time to first publication, time to first citation, and publication quality by award type (basic vs. applied), and whether an award (or publication) is translational.

Evaluation of a mid-career investigator career development award: Assessing the ability of OppNet K18 awardees to obtain NIH follow-on research funding.

The National Institutes of Health (NIH) K18 award mechanism provides funded opportunities for established investigators to gain knowledge in fields outside of their primary disciplines, but outcomes associated with these awards have not been evaluated to date. NIH's Basic Behavioral and Social Sciences Opportunity Network (OppNet) is one of the few initiatives that has used this award mechanism. We explored how the unique features of K18 awards affect the ability of recipients to obtain follow-on NIH research funding. We compared outcomes (ability to obtain follow-on funding and interval between receipt of the primary award and receipt of the first follow-on award) associated with OppNet K18 awards to findings from evaluations of other NIH career development (K) awards, which usually target early-career investigators. We hypothesized that K18 award recipients might be (1) more successful than are other K award recipients in obtaining follow-on NIH research funding due to their career experience or (2) less successful due to the competing demands of other projects. By analyzing follow-on NIH research awards and interview data, we found that OppNet K18 award recipients were at least as successful as were other K award recipients in obtaining follow-on funding and may have been more successful by certain measures. K18 awards produce their outcomes with a lower investment per investigator than do other K awards, suggesting continued or enhanced use of the mechanism.

Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials.

BACKGROUND: The National Cancer Institute (NCI) organized the Operational Efficiency Working Group in 2008 to develop recommendations for improving the speed with which NCI-sponsored clinical trials move from the idea stage to a protocol open to patient enrollment. METHODS: Given the many stakeholders involved, the Operational Efficiency Working Group advised a multifaceted approach to mobilize the entire research community to improve their business processes. New staff positions to monitor progress, protocol-tracking Web sites, and strategically planned conference calls were implemented. NCI staff and clinical teams at Cooperative Groups and Cancer Centers strived to achieve new target timelines but, most important, agreed to abide by absolute deadlines. For phase I-II studies and phase III studies, the target timelines are 7 months and 10 months, whereas the absolute deadlines were set at 18 and 24 months, respectively. Trials not activated by the absolute deadline are automatically disapproved. RESULTS: The initial experience is encouraging and indicates a reduction in development times for phase I-II studies from the historical median of 541 days to a median of 442 days, an 18.3% decrease. The experience with phase III studies to date, although more limited (n = 25), demonstrates a 45.7% decrease in median days. CONCLUSIONS: Based upon this progress, the NCI and the investigator community have agreed to reduce the absolute deadlines to 15 and 18 months for phase I-II and III trials, respectively. Emphasis on initiating trials rapidly is likely to help reduce the time it takes for clinical trial results to reach patients in need of new treatments.