COVID‐19 vaccines and treatments: When speed is necessary and not enough

The willingness to share diverse databases, including experimental conditions, patient risk factors, and outcomes, coupled with standardization and coordination of research methods and end points may, in turn, support faster and more useful insights from emerging artificial intelligence technologies. 5 REGULATORY AGENCIES The public has come to expect that the sense of urgency amongst scientists in R&D will manifest itself in faster regulatory decision making timelines and more rapid deployment of successful candidates; in turn creating new tensions—for example, around the dosing schedules of the approved vaccines. The question-based review for COVID-19 clinical trial data, while focused on efficacy and safety, must also consider the impact of externalities, such as societal, environmental, economic, and political factors on vaccine response and uptake. Vaccine candidate sponsors have made significant efforts to increase the diversity of subjects enrolled in clinical trials, but little data has been generated from subjects in low and middle income countries (LMICs). TABLE 1 Summary of recommendations Recommendation Goals Examples Accelerate learning Ensure coherence across strategic, technical, operational, and impact dimensions of innovation Perform continued assessment of development plans to assess the impact of emerging knowledge Performing multidisciplinary question-based reviews paired with evolving conceptual schemes (including systems pharmacology) Revisiting action plans to reflect emerging insights and gaps Accelerate sharing Standardization and coordination of research methods and end points Implement systematic curation, communication, and collaboration strategies Regulatory collaboration and reliance activities Industry-regulatory process improvements Data portals and platforms, including Vivli, a ICODA, b IDDO, c and ISARIC d Avoid unnecessary duplication Systematic research mapping and strategic profiling Repurpose duplicate trials to study priority risk factors not yet adequately studied in clinical trial settings Precompetitive collaboration Overarching, authoritative repository of funded research projects Future applications of accelerated R&D Perform benefit-to-risk profiling to determine eligibility for acceleration status Globally relevant, multidisciplinary approach to an enhanced clinical utility index Abbreviations: COVID-19, coronavirus disease 2019; R&D, research and development. aVivli: https://vivli.org/. bICODA, International C