Preserving Clinical Trial Integrity During the Coronavirus Pandemic

JAMA
June 2, 2020, Vol 323, No. 21, Pages 2111-2210
https://jamanetwork.com/journals/jama/currentissue

 

Preserving Clinical Trial Integrity During the Coronavirus Pandemic
Mary M. McDermott, MD; Anne B. Newman, MD, MPH
free access has active quiz
JAMA. 2020;323(21):2135-2136. doi:10.1001/jama.2020.4689
This Viewpoint discusses ways the coronavirus pandemic is threatening clinical trial conduct and enrollment, and suggests ways to adapt, including changes to how outcomes data are collected and how interventions are delivered and monitored, to minimize trial disruption, maximize trial benefit, and ensure patient health and safety during the pandemic.

 

Action-Informed Artificial Intelligence—Matching the Algorithm to the Problem

JAMA
June 2, 2020, Vol 323, No. 21, Pages 2111-2210
https://jamanetwork.com/journals/jama/currentissue

 

Action-Informed Artificial Intelligence—Matching the Algorithm to the Problem
Christopher J. Lindsell, PhD; William W. Stead, MD; Kevin B. Johnson, MD, MS
JAMA. 2020;323(21):2141-2142. doi:10.1001/jama.2020.5035
This Viewpoint discusses ways in which artificial intelligence (AI) methods can enhance the use of health care data in detection, prognostication, and prediction; suggests ways in which AI tools might be better developed and deployed; and calls for increased focus on anticipated changes that will be made in the health care system to better benefit from the use of AI.

 

Affording Genetic Therapies in the Medicaid Program

JAMA Pediatrics
June 2020, Vol 174, No. 6, Pages 517-628
http://archpedi.jamanetwork.com/issue.aspx

 

Viewpoint
Affording Genetic Therapies in the Medicaid Program
Jeromie Ballreich, PhD, MHS; Ijeamaka Ezebilo, MD, MPH; Joshua Sharfstein, MD
JAMA Pediatr. 2020;174(6):523-524. doi:10.1001/jamapediatrics.2020.0168
This Viewpoint describes the costs of genetic therapies for children covered by Medicaid and suggests strategies to decrease these costs and thus increase access to these drugs.

 

Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages

Journal of Pediatrics
June 2020 Volume 221, p1-268
http://www.jpeds.com/current

 

Original Articles
Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages
Peter G. Szilagyi, Christina S. Albertin, Alison W. Saville, Rebecca Valderrama, Abigail Breck, Laura Helmkamp, Xinkai Zhou, Sitaram Vangala, L. Miriam Dickinson, Chi-Hong Tseng, Jonathan D. Campbell, Melanie D. Whittington, Heather Roth, Cynthia M. Rand, Sharon G. Humiston, Dina Hoefer, Allison Kempe
p123–131.e4
Published in issue: June 2020

 

Pharmacists reinventing their roles to effectively respond to COVID-19: a global report from the international pharmacists for anticoagulation care taskforce (iPACT)

Journal of Pharmaceutical Policy and Practice
https://joppp.biomedcentral.com/
[Accessed 6 June 2020]

 

Pharmacists reinventing their roles to effectively respond to COVID-19: a global report from the international pharmacists for anticoagulation care taskforce (iPACT)
Authors: Filipa Alves da Costa, Vivian Lee, Silvana Nair Leite, Maria Dolores Murillo, Tom Menge and Sotiris Antoniou
Content type: Commentary
17 June 2020

 

Regenerative medicine: challenges and opportunities

The Lancet
Jun 06, 2020 Volume 395 Number 10239 p1739-1812, e101
https://www.thelancet.com/journals/lancet/issue/current

 

Comment
Regenerative medicine: challenges and opportunities
Giulio Cossu, Robin Fears, George Griffin, Volker ter Meulen
In 2018, the Lancet Commission on stem cells and regenerative medicine1 reported how, despite an exponential growth in experimental therapies, there had been limited clinical uptake. Regenerative medicine comprises various novel approaches such as cell and gene therapy that have produced life-saving therapies for a few genetic diseases affecting blood or skin. Enthusiasm about the broad potential of regenerative medicine led to a gap between expectations and the realities of translating technologies into clinical practice. The Lancet Commission called for rethinking to tackle the combination of problems residing in poor-quality science, unclear funding models, unrealistic hopes, and unscrupulous private clinics.1

 

Mapping geographical inequalities in childhood diarrhoeal morbidity and mortality in low-income and middle-income countries, 2000–17: analysis for the Global Burden of Disease Study 2017

The Lancet
Jun 06, 2020 Volume 395 Number 10239 p1739-1812, e101
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
Mapping geographical inequalities in childhood diarrhoeal morbidity and mortality in low-income and middle-income countries, 2000–17: analysis for the Global Burden of Disease Study 2017
Local Burden of Disease Diarrhoea Collaborators

 

The immune system of children: the key to understanding SARS-CoV-2 susceptibility?

The Lancet Child & Adolescent Health
Jun 2020 Volume 4 Number 6 p407-478, e12-e16
https://www.thelancet.com/journals/lanchi/issue/current

 

Comment
The immune system of children: the key to understanding SARS-CoV-2 susceptibility?
Rita Carsetti, Concetta Quintarelli, Isabella Quinti, Eva Piano Mortari, Alimuddin Zumla, Giuseppe Ippolito, Franco Locatelli

 

Acute lower respiratory infections in Indigenous infants in Australia’s Northern Territory across three eras of pneumococcal conjugate vaccine use (2006–15): a population-based cohort study

The Lancet Child & Adolescent Health
Jun 2020 Volume 4 Number 6 p407-478, e12-e16
https://www.thelancet.com/journals/lanchi/issue/current

 

Articles
Acute lower respiratory infections in Indigenous infants in Australia’s Northern Territory across three eras of pneumococcal conjugate vaccine use (2006–15): a population-based cohort study
Michael J Binks, Jemima Beissbarth, Victor M Oguoma, Susan J Pizzutto, Amanda J Leach, Heidi C Smith-Vaughan, Lisa McHugh, Ross M Andrews, Rosalind Webby, Peter S Morris, Anne B Chang

 

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial

Lancet Infectious Diseases
Jun 2020 Volume 20 Number 6 p629-754, e116-e147
http://www.thelancet.com/journals/laninf/issue/current

 

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial
Milagritos D Tapia, et al on behalf of the Zaire EBola Research Alliance group

 

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial

Lancet Infectious Diseases
Jun 2020 Volume 20 Number 6 p629-754, e116-e147
http://www.thelancet.com/journals/laninf/issue/current

 

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial
Milagritos D Tapia, et al on behalf of the Zaire EBola Research Alliance group

 

Going virtual

Nature Genetics
Volume 52 Issue 6, June 2020
https://www.nature.com/ng/volumes/52/issues/6

 

Editorial | 05 June 2020
Going virtual
One of the many consequences of the global COVID-19 pandemic is the need for the scientific community to adapt to the cancellation of conferences and events because of travel restrictions and social-distancing guidelines. We have seen a very swift conversion to online meetings, which have allowed for this established form of science communication to continue and opened new avenues for innovation in the reporting of research and discussion of ideas.

 

Diverse human genomes

Nature Reviews Genetics
Volume 21 Issue 6, June 2020
https://www.nature.com/nrg/volumes/21/issues/6

 

Research Highlight | 08 April 2020
Diverse human genomes
A study in Science shows that anthropologically informed approaches to genome sequencing can provide a fuller understanding of human genetic variation, including new insights into how past events have led to present-day population structure.
Dorothy Clyde

 

A systems approach to infectious disease

Nature Reviews Genetics
Volume 21 Issue 6, June 2020
https://www.nature.com/nrg/volumes/21/issues/6

 

Review Article | 14 February 2020
A systems approach to infectious disease
This Review outlines a broad, universal framework for systems biology applied to infectious disease research. From study design and omics data collection, analysis, visualization and interpretation to translational outcomes, the authors illustrate how systems biology can provide insights into host–pathogen relationships for the betterment of human health.
Manon Eckhardt
, Judd F. Hultquist[…] & Nevan J. Krogan

 

Beyond broad strokes: sociocultural insights from the study of ancient genomes

Nature Reviews Genetics
Volume 21 Issue 6, June 2020
https://www.nature.com/nrg/volumes/21/issues/6

 

Review Article | 03 March 2020
Beyond broad strokes: sociocultural insights from the study of ancient genomes
With the increasing availability of ancient genomes from the same region or locality, the field of human history has started to address sociocultural aspects of human behaviour. The authors review recent case studies reconstructing the social consequences of past human migrations and advocate that this complex enterprise should be addressed by multidisciplinary teams.
Fernando Racimo, Martin Sikora[…] & Carles Lalueza-Fox

 

Rights, interests and expectations: Indigenous perspectives on unrestricted access to genomic data

Nature Reviews Genetics
Volume 21 Issue 6, June 2020
https://www.nature.com/nrg/volumes/21/issues/6

 

Perspective | 06 April 2020
Rights, interests and expectations: Indigenous perspectives on unrestricted access to genomic data
In this Perspective article, the authors discuss how Indigenous Peoples’ desires for greater involvement and oversight when participating in genomic research projects can be balanced against calls for unrestricted data access. They provide practical recommendations for the handling and sharing of Indigenous genomic data, with the aim of achieving mutual benefit for the research community and participating Indigenous communities.
Maui Hudson, Nanibaa’ A. Garrison[…] & Stephanie Russo Carroll

 

BCG-induced trained immunity: can it offer protection against COVID-19?

Nature Reviews Immunology
Volume 20 Issue 6, June 2020
https://www.nature.com/nri/volumes/20/issues/6

 

Comment | 11 May 2020
BCG-induced trained immunity: can it offer protection against COVID-19?
Could the BCG vaccine be used to bridge the gap until a specific COVID-19 vaccine is developed? Luke O’Neill and Mihai Netea discuss the science behind this approach.
Luke A. J. O’Neill & Mihai G. Netea

 

The trinity of COVID-19: immunity, inflammation and intervention

Nature Reviews Immunology
Volume 20 Issue 6, June 2020
https://www.nature.com/nri/volumes/20/issues/6

 

Review Article | 28 April 2020
The trinity of COVID-19: immunity, inflammation and intervention
In the short time since SARS-CoV-2 infections emerged in humans, much has been learned about the immunological processes that underlie the clinical manifestation of COVID-19. Here, the authors provide an overview of the pathophysiology of SARS-CoV-2 infection and discuss potential therapeutic approaches.
Matthew Zirui Tay, Chek Meng Poh[…]
& Lisa F. P. Ng

 

Defining trained immunity and its role in health and disease

Nature Reviews Immunology
Volume 20 Issue 6, June 2020
https://www.nature.com/nri/volumes/20/issues/6

 

Review Article | 04 March 2020
Defining trained immunity and its role in health and disease
Here a group of leaders in the field define our current understanding of ‘trained immunity’, which refers to the memory-type responses that occur in the innate immune system. The authors discuss our current understanding of the key epigenetic and metabolic processes involved in trained immunity and consider its relevance in immune-mediated diseases and cancer.
Mihai G. Netea, Jorge Domínguez-Andrés[…] & Eicke Latz

 

Cloud-based data systems in drug regulation: an industry perspective

Nature Reviews Drug Discovery
Volume 19 Issue 6, June 2020
https://www.nature.com/nrd/volumes/19/issues/6

 

Comment | 11 November 2019
Cloud-based data systems in drug regulation: an industry perspective
Cloud-based systems for data submitted by sponsors to drug regulatory agencies have the potential to accelerate drug development, streamline regulatory review and enhance regulatory decision-making. Here, we provide a vision for integrating cloud-enabled practices in drug regulation globally.
Andrew S. Robertson, Hilary Malone[…] & Max Wegner

 

Cost-effectiveness evaluations of the 9-Valent human papillomavirus (HPV) vaccine: Evidence from a systematic review

PLoS One
http://www.plosone.org/
[Accessed 6 June 2020]

 

Cost-effectiveness evaluations of the 9-Valent human papillomavirus (HPV) vaccine: Evidence from a systematic review
Rashidul Alam Mahumud, Khorshed Alam, Syed Afroz Keramat, Gail M. Ormsby, Jeff Dunn, Jeff Gow
Research Article | published 02 Jun 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0233499

 

Opinion: Intercepting pandemics through genomics

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/
[Accessed 6 June 2020]

 

Opinion: Intercepting pandemics through genomics
Front Matter
W. John Kress, Jonna A. K. Mazet, and Paul D. N. Hebert
PNAS first published June 3, 2020. https://doi.org/10.1073/pnas.2009508117
Ecological interactions that cross domains of life have major impacts on ecosystems and human health. Although the coronavirus disease 2019 (COVID-19) pandemic makes this point with destructive clarity, it is clear that zoonotic pathogens pose a standing threat to our species as demonstrated by Ebola, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS). Other species experience similar pandemics and are both sources of, and sensitive to, shared pathogens.
Hence, there is an urgent need to establish a global, genomic-based biosurveillance platform, a development which would be of immense value to biosecurity, biodefense, and the economy. If implemented, this “pandemic interception system” would hugely advance our understanding of the natural world…

 

Patents, economics, and pandemics

Science
05 June 2020 Vol 368, Issue 6495
http://www.sciencemag.org/current.dtl

 

Editorial
Patents, economics, and pandemics
By Will Zerhouni, Gary J. Nabel, Elias Zerhouni
Science05 Jun 2020 : 1035
As coronavirus disease 2019 (COVID-19) has quickly killed hundreds of thousands across an unprepared world, destroyed the livelihoods of millions, and cost trillions of dollars, nations must now expand their mindsets and focus not only on overcoming the next phases but also on long-range strategies—for this and for future pandemics. The world needs a permanent preparedness enterprise to engage in a sustained effort to avert pandemics, and provide for the affordable and widespread administration of vaccines and therapies when they are discovered.

Governments, academia, and industry tend to forget the threat of infectious diseases between pandemics, but when they emerge, multibillion-dollar crash programs are quickly put into place.
This boom-and-bust cycle in infectious diseases research and development (R&D) has limited attractiveness to scientists, thus preventing real progress. COVID-19 has mobilized the scientific community to generate hundreds of drugs, diagnostics, and vaccines in various stages of development, but this enthusiasm will quickly evaporate once the crisis is over and funding dries up. Existing governmental and market mechanisms fail to protect society against present and future public health threats, leading to chronic underinvestment in infectious diseases in the private sector and causing many companies to quietly abandon the field. Nonprofit organizations try to fill the gap but are unlikely to meet public health needs. Without sustained government effort and investment, the world will be unprepared for pandemics.

Another reason for the market failure in pandemic protection is an inherent misalignment between economic incentives driving industry versus benefits to the public. Private innovation is driven by the patent system. Pharmaceutical companies, responsive to their shareholders, typically invest in therapies for conditions that will predictably maximize profits during the life of a patent. Patents give a time-limited exclusivity to the innovator who can then set premium pricing that maximizes the return on R&D investment. Such pricing can hinder wide dissemination once vaccines or therapies are developed, often leaving many patients unable to afford these products. Tension therefore exists between the need to generate affordable products that preserve human health and the need of innovators to be appropriately rewarded for their risk taking. This is more critical for vaccines as the individual vaccinee is not the only beneficiary. Indirect positive externalities accrue to the whole of society through faster herd immunity and more rapid economic recovery. In economic terms, this means that such products should be priced as close as possible to marginal costs, a proposition normally unattractive to drug innovators.

How is it possible to resolve this dilemma? A system of ex ante economic rewards should be created based on specific innovation and product development milestones. Governments should contribute not only emergency grant awards (which suffer from the need to pick winners and losers prospectively with scant evidence of effectiveness) but also sustained, predictable, and prospective achievement rewards or even prizes based on the value of explicitly achieved preclinical, clinical, manufacturing, and distribution milestones, including advanced market commitments when necessary to lessen the risk for the innovators who deliver. In exchange, prior to public funds being granted—and to avoid conflicts later—companies that accept taxpayer support would agree to make pandemic countermeasures available to the public rapidly, including widespread production and dissemination with reasonable margins. Today, industry practices such a system of milestone-based payments with their smaller R&D partners. Why should governments not do the same with industry for pandemics?

Similar proposals have been advanced in Europe, with the potential to license discoveries internationally. COVID-19 affects all of humanity, and the strategy should not be geographically restricted but global. Why not join forces? At the upcoming G7 and G20 meetings, governments should create and fund an international organization akin to a global institute of health to manage staged funding through calls for proposals from all sectors. This would sustain the R&D needed to establish rapidly scalable platforms and supply chains of diagnostics, drugs, antibodies, and vaccines against current and future pandemic threats. In exchange, innovators would be fairly rewarded, and their discoveries made available at affordable prices to people around the world. Creating such a sustainable R&D enterprise would be something positive to emerge from the wreckage of COVID-19.

* Employee and shareholder of Sanofi (active in COVID-19 R&D). The views expressed here reflect my personal opinion and are independent of policies/positions of this organization.
† Board member and shareholder of Danaher and shareholder of Sanofi (both involved in COVID-19 R&D).

 

Which interventions work best in a pandemic?

Science
05 June 2020 Vol 368, Issue 6495
http://www.sciencemag.org/current.dtl

 

Policy Forum
Which interventions work best in a pandemic?
By Johannes Haushofer, C. Jessica E. Metcalf
Science05 Jun 2020 : 1063-1065 Full Access
Summary
The only approaches currently available to reduce transmission of the novel coronavirus severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) are behavioral: handwashing, cough and sneeze etiquette, and, above all, social distancing. Policy-makers have a variety of tools to enable these “nonpharmaceutical interventions” (NPIs), ranging from simple encouragement and recommendations to full-on regulation and sanctions. However, these interventions are often used without rigorous empirical evidence: They make sense in theory, and mathematical models can be used to predict their likely impact (1, 2), but with different policies being tried in different places—often in complicated combinations and without systematic, built-in evaluation—we cannot confidently attribute any given reduction in transmission to a specific policy.

 

COVID-19 diagnostics in context

Science Translational Medicine
03 June 2020 Vol 12, Issue 546
https://stm.sciencemag.org/

 

Perspective
COVID-19 diagnostics in context
By Ralph Weissleder, Hakho Lee, Jina Ko, Mikael J. Pittet
Science Translational Medicine03 Jun 2020 Full Access
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has highlighted the need for different types of diagnostics, comparative validation of new tests, faster approval by federal agencies, and rapid production of test kits to meet global demands. In this Perspective, we discuss the utility and challenges of current diagnostics for COVID-19.

 

An opportunity to incentivize innovation to increase vaccine safety in the United States by improving vaccine delivery using vaccine patches

Vaccine
Volume 38, Issue 25 Pages 4057-4134 (22 May 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/25

 

Short communication Full text access
An opportunity to incentivize innovation to increase vaccine safety in the United States by improving vaccine delivery using vaccine patches
Kimberly M. Thompson, Walter A. Orenstein, Alan R. Hinman

 

Trends in school-level vaccination coverage from 2015 to 2018: Increases in exemption rates and declines in herd immunity in Arizona

Vaccine
Volume 38, Issue 25 Pages 4057-4134 (22 May 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/25

 

Research article Abstract only
Trends in school-level vaccination coverage from 2015 to 2018: Increases in exemption rates and declines in herd immunity in Arizona
Pooja Sangha, J. Mac McCullough

 

Case reduction and cost-effectiveness of the RTS,S/AS01 malaria vaccine alongside bed nets in Lilongwe, Malawi

Vaccine
Volume 38, Issue 25 Pages 4057-4134 (22 May 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/25

 

Research article Abstract only
Case reduction and cost-effectiveness of the RTS,S/AS01 malaria vaccine alongside bed nets in Lilongwe, Malawi
Griffin J. Bell, Matthew Loop, Hillary M. Topazian, Michael Hudgens, … Michael Emch

 

Socioeconomic inequality trends in childhood vaccination coverage in India: Findings from multiple rounds of National Family Health Survey

Vaccine
Volume 38, Issue 25 Pages 4057-4134 (22 May 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/25

 

Research article Abstract only
Socioeconomic inequality trends in childhood vaccination coverage in India: Findings from multiple rounds of National Family Health Survey
Nizamuddin Khan, Niranjan Saggurti

 

Regional variation in human papillomavirus vaccination uptake and completion among adolescents 13–17 in the state of Texas

Vaccine
Volume 38, Issue 25 Pages 4057-4134 (22 May 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/25

 

Research article Abstract only
Regional variation in human papillomavirus vaccination uptake and completion among adolescents 13–17 in the state of Texas
Reghan Conrey, Victoria Valencia, Anne Cioletti, M. Yvette Williams-Brown