Clinical trials capacity should be considered strategic asset - BioCentury

The U.S. government should consider creating a strategic national stockpile of capacity for clinical research. Government could also fund and help create a standing network of clinical trial sites that can immediately respond to future pandemics — and keep them “warm” by using them to conduct research on high-priority public health threats.

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Virtual Public Workshop on COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics - Trial Site

Sponsored by Reagan-Udall Foundation, key federal leadership and important stakeholders join a virtual public workshop on September 28 titled  “Federal COVID-19 Response: Clinical Evaluation of Therapeutics Lessons Learned.” 

The event will disseminate findings from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly known as Operation Warp Speed) to bring relevant therapeutics to use in the next public health emergency.

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Post-COVID-19 Syndrome: Leveraging the Patient Perspective and Technological Innovations to Enable the Delineation of Effective Treatments - The Journal Drugs

More than 32 million individuals have survived a confirmed COVID-19 viral infection in the USA [1, 2], and a substantial proportion of post-COVID survivors are suffering from prolonged, recurrent, and/or newly emerging symptoms that span across bodily systems and organs [3]. The spectrum of symptoms and disabilities observed in this setting has been alarming and suggests that the “post-COVID syndrome” is a pan-inflammatory disease with highly variable disease expression and consequences [4]. However, accurately and completely characterizing post-COVID syndrome is difficult because many individuals with acute COVID-19 infection were not hospitalized, and therefore were not tracked through standard, in-patient-based data reporting mechanisms to public health authorities [5].
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Real-World Evidence Accelerator Facing Data Access Challenges For Vaccines - Scrip News for Pink Sheet

The Reagan-Udall Foundation’s Evidence Accelerator program is navigating novel data flow challenges when it comes to assessing the safety and effectiveness of COVID-19 vaccines. The Evidence Accelerator was launched in April 2020 by Reagan-Udall, a foundation that supports the US Food and Drug Administration, and Friends of Cancer Research to identify key questions about the COVD-19 pandemic that could be addressed through real-world data and real-world evidence and pressure-testing approaches to address those questions.
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FDA documents shed light on chaotic COVID decision-making during Trump administration - BioCentury

Internal FDA and White House communications released by FDA in response to a Freedom of Information Act request provide a glimpse into the in-fighting, leaking and chaotic decision-making during some of the most fraught moments of the pandemic during the Trump administration.

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US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization - Pink Sheet

The US Food and Drug Administration is considering new regulatory action to create more consistency in the labeling of investigational drugs to help reduce medication errors and protect patients as well as the integrity of the clinical trial results.

The agency is looking at recommending a harmonized global approach to the issue.

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