A QUALITATIVE STUDY OF COLLABORATIVE RELATIONSHIPS ENABLING PHARMACEUTICAL CLINICAL TRIALS FOR ALZHEIMER’S DISEASE IN LOW- AND MIDDLE-INCOME COUNTRIES

Abstract

With no cure or disease-modifying treatment for Alzheimer’s Disease (A.D.) and high-profile drug failures in recent clinical trials, there remains a global commitment to advancing dementia research and therapeutic innovation. As new clinical trials and research collaborations form, there is limited understanding of the factors that create or hinder equitable relationships between stakeholders that enable pharmaceutical-sponsored A.D. clinical trials and the opportunity to leverage clinical trials for expanded use in health system strengthening. Part One of this thesis examines the potential for health system infrastructure strengthening in low- and middle-income countries (LMICs) through sponsored clinical research. It explores the motivations and influence of pharmaceutical companies in the context of the healthcare ecosystem, articulating their historical and present-day role in clinical trials as the primary funders of late-stage clinical research. Our research proposes that sponsored clinical research can be designed and positioned for greater value and impact to patients and health communities, providing treatments that are so desperately needed while supporting the patients and practitioners they aim to serve. Part Two of this thesis summarizes a qualitative study on the collaborative relationships that enable pharmaceutical clinical trials for Alzheimer’s disease in LMICs. This study used emergence-driven sampling with 19 participants representing four key stakeholders in the A.D. research and clinical trials ecosystem: 1) for-profit industry executives 2) researchers or key opinion leaders 3) government or regulatory leaders 4) members of non-profit organizations and patient advocacy groups. In examining the collaborative practices that enable global clinical research for A.D., study participants elevated perspectives related to professional limitations in their work, which they described as operational barriers, culturalist claims about capability, and limited commercial opportunities. Participants also presented perspectives related to interpersonal behaviors related to fragile trust and creating and maintaining exclusivity. Taken together, these factors explain the lack of investment in LMICs for A.D. clinical trials and point to the inequalities present in this area of clinical research. Part Two concludes with a call to action to rectify the inequalities presented by managing the influential role of pharmaceutical companies and their commercial drivers as new research and clinical trial alliances are formed and passed on. A conscious and deliberate effort is required to create more equitable partnerships in A.D. clinical trials as the global demand for research expands.