Strategy management in collaborative clinical research partnerships.

PURPOSE: Today's clinical trial partnerships frequently join multi-disciplinary investigators and stakeholders, from different countries and cultures, to conduct research with a broad array of goals. This diversity, while a strength, can also foster divergent views about priorities and what constitutes success, thereby posing challenges for management, operations, and evaluation. As a sponsor and partner in such collaborations, we seek to assist and support their development and implementation of sound research strategies, to optimize their efficiency, sustainability, and public health impact. This report describes our efforts using an adaptation of the well-established Kaplan-Norton strategy management paradigm, in our clinical trials setting. We share findings from our first test of the utility and acceptance of this approach for evaluating and managing research strategies in a collaborative clinical research partnership. RESULTS: Findings from pilot studies and our first implementation in an ongoing clinical research partnership in Liberia, provide initial support for our hypothesis that an adapted version of the Kaplan-Norton strategy management model can have use in this setting. With leadership from within the partnership, analysis artifacts were gathered, and assessments made using standardized tools. Practical feasibility, resonance of the findings with partners, and convergence with other empirical assessments lend initial support for the view that this approach holds promise for obtaining meaningful, useable results for assessing and improving clinical research management. CONCLUSIONS AND IMPLICATIONS: Engaged leadership, thoughtful timing to align with partnership planning cycles, support for the process, and an eye towards the collaboration's long-term goals appear important for developing model understanding and practice. Skepticism about evaluations, and unease at exposing weaknesses, may hinder the effort. Acceptance of findings and associated opportunities for improvement by group leadership, support a growing sense of validity. Next steps aim to test the approach in other partnerships, streamline the methodology for greater ease of use, and seek possible correlations of strategy management assessments with performance evaluation. There is hardly a better example than the COVID-19 pandemic, to spotlight the need for efficient and effective clinical research partnerships to address global health challenges. While heartened by the collaborative spirit driving the effort so far, we cannot let our enthusiasm lull us into thinking that nobility of purpose or an abundance of good will is sufficient. Careful monitoring and adjustment of clinical research strategy in response to changes (e.g., demographics, pathogen evolution, research acceptance, political and cultural environments) are vital to making the needed adjustments that can guide these programs toward successful outcomes. We hope that our work can raise awareness about the importance, relevance, and feasibility of sound strategy management in clinical research partnerships, especially during this time when there is so much at stake.

Social Mobilization for Ebola Virus Clinical Trials During a Public Health Crisis in Liberia.

BACKGROUND: At the invitation of the Liberia Ministry of Health and Social Welfare (LMOHSW), the U.S. Department of Health and Human Services joined the LMOHSW in establishing the Partnership for Research on Ebola Virus in Liberia (PREVAIL) to develop treatment and prevention strategies for Ebola virus disease (EVD). Social mobilization was a vital element of PREVAIL in a country with limited history of clinical research. OBJECTIVES: To innovate a social mobilization program for clinical trials during the Liberian EVD outbreak. METHODS: PREVAIL's social mobilization included 1) advocacy for support from leaders, 2) engagement with communities to build trust, and 3) collaboration with media for quality communications.Lessons Learned and Conclusions: Social mobilization can support clinical trials. Trusted leaders and peer to peer communication are essential for sharing reliable information and countering mistrust. Real time monitoring of media can inform timely, specific messaging. Expert evaluation resources are essential for evidence-based effectiveness assessments.