Comment from Coalition for Epidemic Preparedness Innovations (CEPI)

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Summary: The Coalition for Epidemic Preparedness Innovations (CEPI) supports the use of master protocols as a tool for responding to public health emergencies and developing vaccines. They suggest expanding the guidance to include more details on diverse technologies and diseases, as well as clarifying ownership of INDs for multiple products.

Launched in 2017, the Coalition for Epidemic Preparedness Innovations (CEPI) is an international coalition of governments, academic, philanthropic, private, public, and intergovernmental institutions whose vision is to create a world in which epidemics and pandemics are no longer a threat to humanity. CEPI's mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI leverages its unique position within the global health and R&D ecosystems to address market failures, building on its track record of bringing together public-sector, private-sector, and academic partners to accelerate the development of vaccines against emerging viral threats. CEPI welcomes the opportunity to comment on the agency guideline. CEPI view master protocols as an important tool to respond to public health emergencies as well as developing new vaccines against diseases of pandemic potential, but specific considerations on how these clinical trial designs can be implemented for different technologies, diseases, pathogens or emergency situations will be required. Additionally the way in which the clinical trial ecosystems (both within the US and outside the US) prepare for such trials will be critical for their success. Comments: I Introduction •Lines 16-17: CEPI would encourage the agency to consider how this guidance would apply to international trials and how other competent authorities •Lines 30-40: The agency should consider expanding guidance regarding the different master protocols beyond oncology and provide more details including design, regulatory pathways, data management, ethical considerations, and operations. III CONSIDERATIONS ON DESIGN AND ANALYSIS C. Informed Consent •Line 266: Given the criticality of informed consent, an illustration of the example would support a better understanding. IV CONSIDERATIONS ON TRIAL OVERSIGHT, DATA SHARING, AND DISSEMINATION OF INFORMATION Line 480: The option for a cross-over design could be mentioned further up in the section on randomization as well. V.CONSIDERATIONS TO SUPPORT REGULATORY REVIEW Line 518-519: It is unclear and it should be clarified who owns the IND if multiple products are tested

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