RESUMEN
The National Institutes of Health (NIH) Roadmap for Medical Research initiative, funded by the NIH Common Fund and offered through the Clinical and Translational Science Award (CTSA) program, developed more than 60 unique models for achieving the NIH goal of accelerating discoveries toward better public health. The variety of these models enabled participating academic centers to experiment with different approaches to fit their research environment. A central challenge related to the diversity of approaches is the ability to determine the success and contribution of each model. This paper describes the effort by the Evaluation Key Function Committee to develop and test a methodology for identifying a set of common metrics to assess the efficiency of clinical research processes and for pilot testing these processes for collecting and analyzing metrics. The project involved more than one-fourth of all CTSAs and resulted in useful information regarding the challenges in developing common metrics, the complexity and costs of acquiring data for the metrics, and limitations on the utility of the metrics in assessing clinical research performance. The results of this process led to the identification of lessons learned and recommendations for development and use of common metrics to evaluate the CTSA effort.
Asunto(s)
Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/normas , Proyectos de Investigación/normas , Apoyo a la Investigación como Asunto/estadística & datos numéricos , Investigación Biomédica Traslacional/métodos , Investigación Biomédica Traslacional/normas , Distinciones y Premios , Benchmarking/normas , Ensayos Clínicos como Asunto/economía , Comités de Ética en Investigación/normas , Estudios de Factibilidad , Humanos , National Institutes of Health (U.S.) , Proyectos Piloto , Apoyo a la Investigación como Asunto/economía , Factores de Tiempo , Investigación Biomédica Traslacional/economía , Estados UnidosRESUMEN
BACKGROUND: Little is known about how investigators approach their research programs along the translational research continuum. Many consider the translational continuum to be linear, with research beginning at the bench and concluding with research at the bedside or in the community. We aimed to understand if translational investigators approach and view their research in this fashion. METHODS: We conducted semistructured individual interviews with 16 graduates of the University of Pittsburgh's Multidisciplinary Clinical Research Scholars Program (KL2) in 2012. RESULTS: Our research revealed three characteristic models. The first model we called "linear" and represented the traditional approach. The second we called "holistic"; these investigators began with central research questions and sought to explore them in every direction of translation, not necessarily taking linear steps. The third model we called "technical"; in this model, investigators focused on a unique technology or methodology and applied it across multiple research contexts. CONCLUSION: This study found that there are multiple ways that translational investigators approach their research program. Better understanding of these models can help educators and mentors guide investigators so that they can be more productive in their clinical or translational research career.