PMC:7536913 / 664-3717 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7536913","sourcedb":"PMC","sourceid":"7536913","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7536913","text":"BACKGROUND\nPrevious public health crises have changed medical product development and regulatory practices. These examples include major legislative amendments and creative application of regulatory paradigms to address HIV, anthrax and other bioterrorism threats, and infectious diseases. 1 To address the threat of COVID‐19 and simultaneously ensure continuity of development of non‐COVID‐19 treatments, regulators are providing significant regulatory flexibility while maintaining the high standards for quality, safety, and effectiveness. As Rasmus Hougaard argued in a recent Forbes article, “The heat of a crisis creates a burning platform, propelling organizations and individuals to make pivots and changes that seemed too hard or overwhelming during normal times.” 2\nSome of the new policies and procedures allowed regulators to completely reprioritize existing high‐priority public health work and reallocate internal resources in unprecedented ways. Arguably, such changes should be reserved for public health emergencies because they are unsustainable in the long run. However, other interim policies have the potential to endure in a “new normal” way of working to better address public health needs (e.g., repurposed drugs and their combinations with novel therapies), while specific risk‐based policies to accelerate development of potential COVID‐19 therapies and vaccines to an unprecedented level might be applied to other life‐threatening diseases. The World Health Organization (WHO) reports, as of August 10, 2020, the total number of global Covid‐19 confirmed deaths is approximately 728,000. 3 For perspective, this figure is lower than for other leading causes of death. For example, WHO reported the leading causes of global deaths in 2016 were ischemic heart disease and stroke, which claimed 15.2 million lives, and lung cancers (including trachea and bronchus cancers), which caused 1.7 million deaths. 4 And as the world has witnessed the economic and societal costs associated with COVID‐19, other diseases share similar burdens. These data indicate it would be appropriate to apply the same sense of urgency and innovation to areas beyond COVID‐19. We are supportive of many of the proposals being discussed by regulators and other groups identifying transformative practices, e.g., use of digital technologies and flexibility in statistical approaches. 5\nHere, we provide an industry regulatory perspective on durable learnings and innovation that may emerge from the COVID‐19 experience; they fall into two major categories. First would be innovation in clinical trials and regulatory frameworks, enabled by digital technologies that may increase the efficiency and acceptability to both patients and investigators. Second is the application of the same level of regulatory urgency, responsiveness, and flexibility in requirements seen with COVID‐19 solutions to other serious life‐threatening and/or debilitating diseases that remain major causes of mortality and suffering. These are described in more detail 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