A risky business: politics, bureaucracy, and the commercialisation of the global clinical trial

A risky business: politics, bureaucracy, and the commercialisation of the global clinical trial

·       Objective 1: Conduct final interviews and consultations with WHO COVID-19 guidance development group methodologists and staff. I have begun virtual interviews with WHO staff involved in guidance for hydroxychloroquine and the wider guidance development group and MAGIC Ecosystem Foundation partnership for global guidance production. I will also have visited Geneva in the spring of 2023 to hold initial meetings. During my time at Brocher, as I analyse earlier interviews in more detail, I will follow-up with WHO colleagues to ensure accurate representation of their perspectives in my research. I will also discuss regulatory harmonisation activities, such as the Geneva coordination of the SEARO and AFRO harmonisation activities, with WHO staff. This will help me to ensure that my global coordination and pathway forward chapters of the book are as up-to-date as possible. The output of this objective is holding at least 3-4 interviews with senior level stakeholders, and having informal fact-checking with additional partners.

·       Objective 2: Consult files on the ICH and WHO interactions with the International Federation of Pharmaceutical Manufacturing Associations (IFPMA) at the WHO archives. I have visited WHO Archives during my last Brocher residency in 2018, but they have been closed due to renovations this year. I have a 4-day visit planned for April 2023 and have consulted the archivist Reynald Erard to determine what files will be available. I anticipate that I will identify additional folders relevant to the WHO’s interaction with non-state actors in the pharmaceutical sector during this trip. My output during the residency will be to consult all additional relevant files about IFPMA and the “FENSA” (non-state actor framework for engagement) at the WHO archives.

·       Objective 3: Network with global health governance scholars, with expertise in power, influence, and pandemic governance, at the Graduate Institute Geneva. I have previously worked with Gian-Luca Burci at the National Academy of Science in Washington DC, and met Suerie Moon at the Brocher symposium that I co-lead in 2019 (as well as through the Academies). These two scholars have invaluable backgrounds in technical areas relevant to my book and broader research project, particularly on typologies of power in global health and sample sharing laws. My output will be to meet with them and their research teams while I am drafting the relevant final sections of my book. This will both help me to plan future collaborations and will be invaluable perspective for the book’s concluding section on future governance pathways.

·       Objective 4: Complete book on pandemics, politics, and the commercialisation of the global clinical trial for submission to editorial team. As described previously, my major output will be to finalise the 12 chapter draft of my book and have it ready for submission to the editorial body.  

·       Objective 5: Liaise with editors about the book proposal draft chapters and integrate feedback into book. I anticipate that the book will be under contract before I begin my residency, and that I will have had initial feedback on the first submitted chapters from the editorial team. A major output of my residency will be to meaningfully respond to initial review and critique, and use this to adapt the book’s structure as needed.

·       Objective 6: If time permits, perform interviews with malariologists at the Global Fund, MMV, and WHO Global Malaria Programme. This project, as described briefly above, forms much of the next phase of my research, on malaria research policy and policy-setting. The output will be meeting with at least 2-3 major stakeholders from malaria public-private partnerships and multilateral organisations in Geneva, to further develop these research proposals and finalise publication of a paper on the modern history of paediatric primaquine production.

Constructing success: the World Bank, WHO and the Onchocerciasis Control Programme in West Africa (1974-2002)