Evidence–time dilemma in a pandemic with high mortality: Can outcome‐driven decision making on vaccines prevent deaths?

Eckhardt, Klaus

doi:10.1111/cts.13155

Cited by 3 publications

(2 citation statements)

References 8 publications

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“… 13 , 14 , 15 , 16 Rethinking how we manage change and substantiate evidence under uncertainty with the right sense of urgency has transformed drug and vaccine development, as witnessed during the COVID‐19 pandemic. 17 , 18 , 19 , 20 , 21 Commitment to a growth mindset, totality of evidence approach, and trust are crucial to maximizing diversity and inclusion in drug development to enable the broadest possible access to medicines for all patients. 22 , 23 No scientist can expect to be an expert in all scientific specialties and research methods, necessitating comfort with gaps in knowledge and competencies, and in treating failures as learning opportunities.…”

Section: Discussionmentioning

confidence: 99%

“…Emerging areas like artificial intelligence and machine learning, and real‐world data analytics are becoming integral components of the practice of Translational Medicine 13–16 . Rethinking how we manage change and substantiate evidence under uncertainty with the right sense of urgency has transformed drug and vaccine development, as witnessed during the COVID‐19 pandemic 17–21 . Commitment to a growth mindset, totality of evidence approach, and trust are crucial to maximizing diversity and inclusion in drug development to enable the broadest possible access to medicines for all patients 22,23 .…”

Section: Discussionmentioning

confidence: 99%

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How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model

Zheng

Venkatakrishnan

Kennedy³

2022

Clinical Translational Sci

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Enhancing resiliency should elevate innovation and efficiency in biomedical research and development (R&D); however, compared with other professions, data on practice of resilience is lacking. Using the Benatti Resiliency Model (5 anchors: Well‐Being, Self‐Awareness, Brand, Connection, and Innovation), we surveyed professionals, including those in biomedical and pharmaceutical R&D. A structured LinkedIn questionnaire (March 16–May 23, 2021), surveyed each model anchor using five categories. One hundred fifty‐eight participants (~6% student/trainee, 18%, 27%, and 49% in 1–5, 5–15 or >15 years post‐terminal degree) took the survey (90 in biomedical and pharmaceutical R&D). Over 50% chose “always”/“often” across questions, except external influence or engagement. The question with one of the lowest “always” scores (~15%) was “I get feedback on my influence and impact in my career” in Brand, highlighting areas for leadership development and coaching. In the anchor of Well‐being, nutrition and stress management also received some lowest “always” scores (~15% for both). Connection and Innovation scores trended slightly higher in biomedical and pharmaceutical R&D. No students/trainees chose “always” in Brand, indicating evolution of brand maturity over time. Self‐ and survey‐assessed resiliency scores were associated (rs = 0.37, p < 0.0001). Our survey yielded actionable insights on Resilience, including “best practices” through an open‐ended question for one thing most useful to boost resilience in the survey and is the first application of the Benatti Model for crowdsourced research.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model

Zheng

Venkatakrishnan

Kennedy³

2022

Clinical Translational Sci

View full text Add to dashboard Cite

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Clinical trials for accelerating pandemic vaccines

Więcek

2022

Oxford Review of Economic Policy

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We provide a short overview of clinical trials of vaccines, with particular focus on (i) adaptive and platform trials, (ii) human challenge trials, and (iii) vaccine use optimization, especially fractional dosing. We describe their relationship with regulatory approval and review main developments during Covid-19. We review the literature on risk–benefit analyses of alternative testing approaches but find few results, suggesting need for further quantitative research. We conclude by discussing some lessons for the next pandemic, such as the need for pre-pandemic R&D and clear guidelines; improving capability to use new trial approaches; arguments for diversifying research methods; research incentives and disincentives; and the need to use risk–benefit in approving new vaccines and targeting.

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