PMC:7536913 / 664-3717 JSONTXT 10 Projects

Annnotations TAB TSV DIC JSON TextAE

Id Subject Object Predicate Lexical cue
T7 0-10 Sentence denotes BACKGROUND
T8 11-107 Sentence denotes Previous public health crises have changed medical product development and regulatory practices.
T9 108-289 Sentence denotes These examples include major legislative amendments and creative application of regulatory paradigms to address HIV, anthrax and other bioterrorism threats, and infectious diseases.
T10 290-543 Sentence denotes 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.
T11 544-776 Sentence denotes 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
T12 777-961 Sentence denotes Some of the new policies and procedures allowed regulators to completely reprioritize existing high‐priority public health work and reallocate internal resources in unprecedented ways.
T13 962-1081 Sentence denotes Arguably, such changes should be reserved for public health emergencies because they are unsustainable in the long run.
T14 1082-1468 Sentence denotes 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.
T15 1469-1615 Sentence denotes The World Health Organization (WHO) reports, as of August 10, 2020, the total number of global Covid‐19 confirmed deaths is approximately 728,000.
T16 1616-1696 Sentence denotes 3 For perspective, this figure is lower than for other leading causes of death.
T17 1697-1932 Sentence denotes 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.
T18 1933-2062 Sentence denotes 4 And as the world has witnessed the economic and societal costs associated with COVID‐19, other diseases share similar burdens.
T19 2063-2182 Sentence denotes These data indicate it would be appropriate to apply the same sense of urgency and innovation to areas beyond COVID‐19.
T20 2183-2387 Sentence denotes 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.
T21 2388-2389 Sentence denotes 5
T22 2390-2560 Sentence denotes Here, 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.
T23 2561-2751 Sentence denotes 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.
T24 2752-3011 Sentence denotes 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.
T25 3012-3053 Sentence denotes These are described in more detail below.