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T 27: So You Want to Influence Stakeholders…Now What? How Outreach Programs can Advance Clinical Research
Jui R. Shah
Health Scientist Administrator, NIAID, Clinical Research Resources Branch
National Institutes of Health (NIH) United States
To share how a U.S. Government Agency, sponsoring a global portfolio of HIV/AIDS clinical trials, leveraged a CRO relationship to optimize communication strategies and knowledge sharing with stakeholders via an outreach program promoting regulatory compliance and successful clinical trial conduct.
An outreach program involving 1) face-to-face interactions, 2) in-person, webinar-based, and on-demand trainings, and 3) development and deployment of tools and resources was implemented to ensure regulatory and procedural compliance and the successful conduct of complex HIV/AIDS clinical trials.
Engagement with external stakeholders and the use of metrics to identify issues and document issue resolution have been critical to the success of the multipronged outreach program created and advanced by a Government-CRO relationship. The Division of AIDS’ Regulatory Support Center (DAIDS RSC), which is run by the CRO, has been integral to the proactive identification and resolution of stakeholder issues. Stakeholder engagement via face-to-face outreach such as Information Booths and consultative sessions held by the DAIDS RSC at network meetings, presentations and meetings with DAIDS’ clinical trial Network Operations Centers, as well as a “DROP-IN” program where DAIDS and DAIDS RSC personnel meet clinical trial site staff on location, have been used. Electronic engagement methods such as tutorials and e-Learning, as well as tools and resources such as checklists, and how-to videos, made available via the public and mobile-accessible website, created and maintained by the DAIDS RSC, have also been used for certain tasks. Project management principles have been applied to these outreach efforts, such as: 1) the systemic roll out of e-Learning modules to optimize the use of new DAIDS policy manuals on safety reporting and essential document submissions; 2) the delivery of training to remote international locations in planning for audits; and 3) the implementation of applicable procedures to ensure cost-effective compliance with regulations during the protocol lifecycle. These outreach efforts have helped the Government to proactively identify and address gaps in awareness about available clinical research resources, process inefficiencies, and other issues, such as optimization of the use of a Clinical Trial Management System (CTMS) called the NIAID Clinical Research Management System (N-CRMS), as the database of record for DAIDS’ large global clinical trial portfolio.
The Government–CRO relationship has been an integral part of the Government’s efforts to implement more efficient processes and maximize the use of new technologies to advance HIV/AIDS clinical research (including >230 active protocols under ~90 INDs) being performed by >360 DAIDS clinical research sites in >20 countries around the world. The face-to-face and electronic stakeholder engagement methods, as well as the resources and tools made available on the DAIDS RSC’s public, mobile-accessible website through the outreach program have all led to effective sponsor oversight and improved efficiencies that have helped to optimize clinical research operations across DAIDS, the DAIDS RSC and DAIDS’ other stakeholders. In addition, the project management principles applied to the coordinated, systematic roll-out of various parts of the program, such as e-Learning modules developed to coincide with the launch of new DAIDS policies, as well as continuous analysis of the impact of these programs, have been crucial to the success of the outreach efforts. The stakeholder engagement experience with the DAIDS RSC shows that the Government can effectively leverage its CRO relationships to develop and implement an outreach program to facilitate the support of critical clinical research in advancing the fight against HIV/AIDS in diverse regions around the world, including clinical trial sites in resource-limited settings. [This was supported by DAIDS, NIAID NIH contract HHSN272201000013C].