Pandemic Preparedness Now: Sleeper Framework for Human Challenge Studies
The COVID-19 pandemic showed that scientific capability alone is not enough to mobilise complex clinical research at pandemic speed. Human challenge studies generated valuable evidence, but time spent establishing governance, ethics, regulation, manufacturing and contracting meant SARS-CoV-2 studies began later than they might have done. Pandemic Preparedness Now: Sleeper Framework for Human Challenge Studies proposes a standing framework to bring key decisions forward. If a new pandemic threat emerges, this framework is designed to make it possible to begin preparatory work on human challenge studies on Day 1, without pre-committing governments to proceed. Adopting this framework would help prevent avoidable delays, preserve optionality, and enable human challenge studies to generate vital evidence to support the next pandemic response.
Implementing AI-Assisted Transparency Initiatives at the FDA
This report argues that the FDA’s decision to publish Complete Response Letters (CRLs) could be strengthened by adopting carefully designed AI-assisted transparency tools. It suggests that AI-powered redaction, paired with human oversight and sponsor review, could reduce staff burden, improve consistency, and support timely publication while protecting trade secrets. The report also contends that AI systems could make CRLs more usable by enabling search, aggregation, and comparative analysis across the growing archive. Over time, it suggests that well-governed AI could help the FDA responsibly share higher-level insights from sensitive regulatory data, advancing transparency while preserving public trust.
Mandatory Publication of FDA Complete Response Letters with AI-Assisted Redaction
The FDA’s promise to publish unapproved complete response letters (CRLs) was previously constrained by legal interpretations and operational burdens, but the convergence of regulatory will, commitment to transparency, and technological capability has made reform possible. By adopting AI-assisted redaction, analysis, or information processing, the FDA could build on the promise of real-time CRL publication to provide further transparency without compromising trade secrets or overwhelming staff.
This whitepaper explores the history of CRLs and provides recommendations on how to implement AI to deliver real-time CRL reports.
Establishing an AI corps to accelerate HHS transformation
Authored as part of the Federation of American Scientists’ Day One project, From Strategy to Impact: Establishing an AI Corps to Accelerate HHS Transformation lays out a plan of action on how to unlock the full potential of AI within the Department of Health and Human Services’ 10 agencies through the establishment of an AI Corps, using the FDA as a case study.
Improving regulator capacity through artificial intelligence
The pharmaceutical industry frequently cites review delays and the limited availability of Food and Drug Administration (FDA) interactions as a key bottleneck in drug approval processes. Improving Regulator Capacity through Artificial Intelligence lays the groundwork for integrating AI and existing FDA reviewers to improve upon existing processes. This piece was prepared for the Clinical Trials Abundance project, a partnership between the Institute for Progress (IFP) & Renaissance Philanthropy.
Fair pay: Legalizing comprehensive compensation in clinical trials
Removing barriers to fairly compensating participants in clinical trials is crucial for accelerating medical research and ensuring diverse participation. Fair Pay: Legalizing Comprehensive Compensation in Clinical Trials explains how to remove significant barriers to recruitment by amending the regulations that encourage IRBs to arbitrarily limit compensation and exempt trial income from tax calculations. This piece was prepared for the Clinical Trials Abundance project, a partnership between the Institute for Progress (IFP) & Renaissance Philanthropy.
Unblocking human challenge trials for faster progress
Human challenge trials can cut costs, reduce risks for drug companies, and speed the development of critically needed treatments. However, particularly in the US, HCTs are held back by burdensome manufacturing requirements, outdated quality assurance standards, and a lack of clarity on their utility for drug approval. Unblocking Human Challenge Trials for Faster Progress details how to remedy this. This piece was prepared for the Clinical Trials Abundance project, a partnership between the Institute for Progress (IFP) & Renaissance Philanthropy.
New incentives to lower disease burden through biomarkers and surrogate endpoints
Authored as part of the Federation of American Scientists’ Day One project, Slow Aging, Extend Healthy Life: New Incentives to Lower the Late-Life Disease Burden through the Discovery, Validations, & Approval of Biomarkers and Surrogate Endpoints explores how the U.S. should establish a comprehensive framework to incentivize the discovery, validation, and regulatory approval of biomarkers as surrogate endpoints to accelerate clinical trials and increase the availability of health-extending drugs.
Avoiding another lost decade to malaria vaccines
After decades of research and development, two new malaria vaccines entered routine administration this year and are projected to save 180,000 children’s lives by 2030. But under current plans, roughly 2.5 million children will die of malaria unvaccinated over the same period. What’s stopping a faster rollout? Avoiding Another Lost Decade to Malaria Vaccines, a collaborative effort between The Center for Global Development and 1Day Sooner, asked this question to government officials across Africa, staff at Gavi, the WHO, and the US President’s Malaria Initiative, and international NGOs like PATH.
Saving a trillion dollars with a universal coronavirus vaccine
What if we had a vaccine that protected against all major illness-causing coronaviruses? An Advanced Market Commitment to Incentivize a Universal Coronavirus Vaccine Before the Next Variant explains how few billion dollars in the form of an advanced market commitment could stimulate the development of such a vaccine. Just counting averted deaths alone, it could be worth $1.08 trillion in value.
Air Safety to Combat Global Catastrophic Biorisk
One day, humanity may look back on things like flu like you and I look at cholera today: the unpleasant but inevitable outcome of a failure to clean things properly. Like we use chlorine to clean our water, we may end up using far-UV light, proper filtration, and ventilation to rid the air of contamination on a massive scale. Air Safety to Combat Global Catastrophic Biorisk, a collaborative effort between 1Day Sooner and Rethink Priorities, outlines the next steps to get there.
1Day Volunteers Driven Primarily by Altruism
1Day Sooner’s research team analyzed survey data about COVID-19 human challenge trial volunteers, with the results published in PLOS ONE in November 2022.
Exploring the risks of human challenge trials for COVID-19
We introduce an interactive model for exploring some risks of a SARS-COV-2 dosing study, a prerequisite for any COVID-19 challenge trials. Read the full paper here.
40 years of challenge studies and zero deaths
Read the systematic review of human challenge studies from 1980 to 2021 in Clinical Infectious Diseases.
COVID-19 challenge trial risk model
1Day Sooner’s challenge trial model estimates the risk of death and hospitalization for potential participants in a COVID-19 human challenge trial. Users can adjust the expected risks based on the ages of participants, their gender, their pre-existing health level, and number of participants in a COVID-19 challenge trial. Analogous risks are displayed at the top of the model.
Universal flu vaccine
1Day Sooner’s report reviews current and proposed efforts for a universal influenza vaccine, and provides some background information on influenza relevant to universal vaccine development through human challenge trials. It does not attempt a comprehensive overview of the field of influenza vaccine development— those interested in an in-depth approach are encouraged to look at NIAD’s roadmap for universal influenza vaccine development. We also provide a resource repository of relevant literature. Read full report from January 2021.
Ethical considerations for challenge trials
Informed consent forms the cornerstone of contemporary medical ethics. A COVID-19 human challenge trial imposes unusual burdens and risks on healthy participants. It is therefore critical that research personnel create a robust screening and informed consent process to ensure participants do not find themselves subject to burdens and risks to which they might not have otherwise consented.
This report attempts to identify, evaluate and address barriers to genuine informed consent that arise in this novel context at various stages in the informed consent process. These stages include: selection of participants, training of personnel, screening, providing information, giving of consent, and ongoing consent until the end of the study. Read the full report from August 2020 or our summary of ethical considerations.
Long-term risks of COVID-19
Current literature most prominently supports both cardiopulmonary and neurological long-term effects. Many of these effects appear to be linked to the severity of COVID-19 infection; populations that are younger, more female, and healthier than normal may suffer less from COVID-19. It is too early to definitively say to what degree cardiac or pulmonary damage is permanent; however, it is possible that other organs such as the kidneys and testicles may be implicated in long-term damage. Read our full report from July 2020 or reference our long-term risks FAQ.