Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks
Version of Record online: 13 NOV 2013
© 2013 John Wiley & Sons Ltd
Journal of Evaluation in Clinical Practice
Volume 20, Issue 2, pages 149–157, April 2014
How to Cite
Rosas, S. R., Cope, M. T., Villa, C., Motevalli, M., Utech, J. and Schouten, J. T. (2014), Assessing the challenges of multi-scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks. Journal of Evaluation in Clinical Practice, 20: 149–157. doi: 10.1111/jep.12100
- Issue online: 10 MAR 2014
- Version of Record online: 13 NOV 2013
- Manuscript Accepted: 15 OCT 2013
- United States government Department of Health and Human Services, National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID). Grant Number: U01AI068614
- clinical trial efficiency;
- cross-network collaboration;
- multi-network clinical trials;
- resource sharing
Rationale, aims, and objectives
Large-scale, multi-network clinical trials are seen as a means for efficient and effective utilization of resources with greater responsiveness to new discoveries. Formal structures instituted within the National Institutes of Health (NIH) HIV/AIDS Clinical Trials facilitate collaboration and coordination across networks and emphasize an integrated approach to HIV/AIDS vaccine, prevention and therapeutics clinical trials. This study examines the joint usage of clinical research sites as means of gaining efficiency, extending capacity, and adding scientific value to the networks.
A semi-structured questionnaire covering eight clinical management domains was administered to 74 (62% of sites) clinical site coordinators at single- and multi-network sites to identify challenges and efficiencies related to clinical trials management activities and coordination with multi-network units.
Overall, respondents at multi-network sites did not report more challenges than single-network sites, but did report unique challenges to overcome including in the areas of study prioritization, community engagement, staff education and training, and policies and procedures. The majority of multi-network sites reported that such affiliations do allow for the consolidation and cost-sharing of research functions. Suggestions for increasing the efficiency or performance of multi-network sites included streamlining standards and requirements, consolidating protocol activation methods, using a single cross-network coordinating centre, and creating common budget and payment mechanisms.
The results of this assessment provide important information to consider in the design and management of multi-network configurations for the NIH HIV/AIDS Clinical Trials Networks, as well as others contemplating and promoting the concept of multi-network settings.