Research & Publications

Below, you can find academic publications by the 1Day Sooner research team and 1Day Sooner affiliates (in bold) related to our work.

Standardizing controlled human infection publication

Jupiter Adams-Phipps and Dan Toomey (March 2023, preprint), “Standardizing Controlled Human Infection Study Reporting Discussion and Guidelines.”

This paper discusses the challenges of conducting research on challenge studies stemming in part from the wide variance in terminology used to describe these studies. The authors proposed the adoption of “Controlled Human Infection Study”. The paper also highlights the lack of standardized reporting of adverse events among challenge study participants, making trends in safety and breakdowns of risk by disease, among other useful information, functionally impossible to determine.

Doing more to honor volunteers in medical research

Stephanie A. Kraft, Abie Rohrig, Anthony Williams, and Seem K. Shah (January 2023), “Better recognition for research participants: what society should learn from covid-19,” BMJ 380: e071178.

Society has significant obligations to medical research volunteers, who “enable advances in science and medicine related to a wide range of conditions and diseases, thereby contributing to the public good.”. It is universally agreed that studies and researchers ought to “respect” volunteers, but “respect” is often construed very narrowly, focusing mainly on respect for individual autonomy and the nonviolation of their civil and legal rights. This paper argues that there are many ways that respect for volunteers can and should be further expanded, from measures such as guaranteeing medical care and compensation in the case of study-related injury in the United States (where there is no law requiring such a guarantee) to improving the public recognition of volunteers and their contributions to modern medicine.

Altruism in those willing to volunteer for Covid-19 challenge studies

Abigail A. Marsh, Monica Magalhaes, Matthew Peeler, Sophie M. Rose, Thomas C. Darton, Nir Eyal, Josh Morrison, Seema K. Shah, and Virginia Schmit (November 2022), “Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials,” PLOS ONE 17(11): e0275823.

This study compared 1Day Sooner volunteer survey results against a control, gaining insight into the motives of tens of thousands who signed up with us during the pandemic. The sample from 1Day Sooner’s nearly 40,000 volunteers showed higher levels of altruistic thinking, and notably, did not have deficits in risk assessment or reasoning — they were altruistic, but not reckless, contrary to some concerns expressed during the pandemic.

40 years of challenge studies and zero deaths

Jupiter Adams-Phipps, Danny Toomey, Witold Więcek, Virginia Schmit, James Wilkinson, Keller Scholl, Euzebiusz Jamrozik, Joshua Osowicki, Meta Roestenberg, David Manheim (October 2022), “A Systematic Review of Human Challenge Trials, Designs, and Safety,” Clinical Infectious Diseases: ciac820.

1Day Sooner researchers and other scientists conducted a systematic review of published human challenge trials from 1980 to 2021 in Clinical Infectious Diseases. In total, over 15,000 participants took part in hundreds of different studies involving over two dozen pathogens, including Influenza, Plasmodium (malaria), SARS-CoV-2, Rubella, and E. coli. No deaths were reported. 10,016 volunteers were in studies that reported severe adverse effects (SAEs); only 23 SAEs occurred. The authors conclude it was unlikely that any of the 23 were even life-threatening, “because the events were primarily brief hospitalizations for observation or supportive care requiring noninvasive interventions or falling under the broad category of ‘other serious (important medical events)’ in the FDA definition of SAEs.”

Covid-19 volunteer risk modeling

David Manheim, Witold Wiȩcek, Virginia Schmit, Josh Morrison, and the 1Day Sooner Research Team (May 2021), “Exploring Risks of Human Challenge Trials For COVID-19,” Risk Analysis 41(5): 710–20.

1Day Sooner introduced an interactive model in Risk Analysis for exploring some risks of a SARS-COV-2 dosing study, a prerequisite for any COVID- 19 challenge trials. The risk estimates were based on a Bayesian evidence synthesis model which can incorporate new data on infection fatality rates (IFRs) to patients, and infer rates of hospitalization. Using young, healthy volunteers, the chances of a study resulting in a fatality were extremely low. The model is available under an open license along with the data and source code on GitHub.

How and when should challenge studies be used for Covid-19?

Linh Chi Nguyen, Christopher W. Bakerlee, T. Greg McKelvey, Sophie M. Rose, Alexander J. Norman, Nicholas Joseph, David Manheim, Michael R McLaren, Steven Jiang, Conor F. Barnes, Megan Kinniment, Derek Foster, Thomas C. Darton, and Josh Morrison (February 2021; orig. published July 2020), “Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development,” Clinical Infectious Diseases 72(4): 710–715.

First published in the summer of 2020, this paper discusses three potential use cases of human challenge trials in the Covid-19 pandemic: for evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. Complex ethical issues involved in infecting volunteers with a novel disease for which there is no cure, but ultimately, the potential benefits are substantial enough to warrant serious consideration.