Advancing Translational Research Collaborations

Portilla, Lili; Evans, Greg; Eng, Benjamin; Fadem, Terry J.

doi:10.1126/scitranslmed.3001636

Cited by 7 publications

(9 citation statements)

References 6 publications

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Section: Discussionmentioning

confidence: 99%

“…Translational researchers must have multidisciplinary knowledge and capability [ 66 ].Translational researchers need to have the collaboration skills to allow ensure clinicians and scientists to function in effective inter-professional, multidisciplinary teams [ 67 ]. Therefore, current medical education program must be tailored towards training multidisciplinary translational researchers in order to achieve the full benefits and promising applications of translational medicine [ 68 ].…”

Section: Discussionmentioning

confidence: 99%

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Challenges facing translational research organizations in China: a qualitative multiple case study

Zhou

Bosworth

et al. 2013

J Transl Med

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BackgroundTranslational medicine is attracting much attention worldwide and many translational research organizations (TROs) have been established. In China, translational medicine has developed rapidly, but faces many challenges. This study was aimed at exploring these challenges faced by emerging TROs in China.MethodA qualitative, multiple case study approach was used to assess the challenges faced by TROs in China. Data were collected between May and August 2012.ResultsEight cases were identified. Overall, four themes that characterized TROs in China emerged from analyses: 1. objectives, organizer, and funding resources, 2. participating partners and research teams, 3. management, and 4. achievements. All TROs had objectives related to translating basic discovery to clinic treatment and cultivating translational researchers. In terms of organizer and funding resources, 7 out of 8 TROs were launched only by universities and/or hospitals, and funded mostly through research grants. As for participating partners and multidisciplinary research teams, all but one of the TROs only involved biomedical research institutions who were interested in translational research, and characterized as clinical research centers; 7 out of 8 TROs involved only researchers from biomedicine and clinical disciplines and none involved disciplines related to education, ethnicity, and sociology, or engaged the community. Current management of the TROs were generally nested within the traditional research management paradigms, and failed to adapt to the tenets of translational research. Half of the TROs were at developmental stages defined as infrastructure construction and recruitment of translational researchers.ConclusionsTROs in China face the challenge of attracting sustainable funding sources, widening multidisciplinary cooperation, cultivating multi-disciplinary translational researchers and adapting current research management to translational research. Greater emphasis should be placed on increasing multidisciplinary cooperation, and innovating in education programs to cultivate of translational researchers. Efforts should be made to reform research management in TROs, and establish sustainable funding resources.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Challenges facing translational research organizations in China: a qualitative multiple case study

Zhou

Bosworth

et al. 2013

J Transl Med

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“…Developing robust business models to underpin clinical research is a vital step in the evolution of the CTSA (13, 14), and an undeniable part of that evolution is now cost recovery. In the face of challenged industry pipelines (15, 16), radical new business models are being established to drive translation in drug development (17–19), and with the synergies of collaboration (20–22), the CTSA consortium is well placed to contribute to this new translational climate.…”

Section: Discussionmentioning

confidence: 99%

From Free to Free Market: Cost Recovery in Federally Funded Clinical Research

et al. 2012

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In a climate of increased expectation for the translation of research, academic clinical research units are looking at new ways to streamline their operation and maintain effective translational support services. Clinical research, although undeniably expensive, is an essential step in the translation of any medical breakthrough, and as a result, many academic clinical research units are actively looking to expand their clinical services despite financial pressures. We examine some of the hybrid academic-business models in 19 clinical research centers within the Clinical and Translational Science Award consortium that are emerging to address the issue of cost recovery of clinical research that is supported by the United States federal government. We identify initiatives that have succeeded or failed, essential supporting and regulatory components, and lessons learned from experience to design an optimal cost recovery model and a timeline for its implementation.

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“…The regulations governing human research in the United States are more than 30 years old (http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html). The architects of what would become The Common Rule could not have anticipated the degree to which, in today’s environment, successful research often relies upon collaboration of investigators at different institutions, and sharing of both data and biospecimens (Portilla, Evans, Eng, & Fadem, 2010). The need to aggregate information and materials from different institutions can create unique challenges for investigators as well as regulators (Guterman, 2010; McGraw et al., 2012).…”

Section: Introductionmentioning

confidence: 99%

Investigator Experiences and Attitudes About Research With Biospecimens

Rivera

Goldenberg

Rosenthal

et al. 2015

Journal of Empirical Research on Human Research Ethics

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To advance scientific knowledge about human diseases and effective therapeutic treatments, investigators need access to human biospecimens and associated data. However, regulatory and procedural requirements may impede investigators’ efforts to share biospecimens and data within and across institutions. While a number of studies have explored experiences and attitudes of study participants and others about biospecimen and data sharing, less is known about investigators’ perspectives. We conducted an electronic survey to learn about investigators’ experiences and attitudes about research with biospecimens and associated data. A total of 114 practicing scientists from a pool of 60 university medical schools with Clinical and Translational Science Awards (CTSAs) funded by the National Institutes of Health (NIH) participated. We found a high degree of variability in investigators’ experiences with Institutional Review Boards (IRBs) when seeking approval to conduct biospecimen research, as well as differences in approaches to informed consent for the collection of specimens. Participants also expressed concerns that the risks of biospecimen research may be overestimated by IRBs. This research suggests that the current regulatory environment for human research protections may require reconsideration with regard to standards for collection, use and sharing of biospecimens and data.

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Advancing Translational Research Collaborations

Abstract: A 2010 NIH forum investigated how barriers to collaboration among academia, government, and industry must be identified and overcome to maximize the clinical return on investment in science (see also the five accompanying meeting reports).

Cited by 7 publications

References 6 publications

Challenges facing translational research organizations in China: a qualitative multiple case study

Challenges facing translational research organizations in China: a qualitative multiple case study

From Free to Free Market: Cost Recovery in Federally Funded Clinical Research

Investigator Experiences and Attitudes About Research With Biospecimens

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