PreprintConcept PaperVersion 1Preserved in Portico This version is not peer-reviewed
A Novel Feasibility Study Design Enabling Informative Clinical Trials in Low Resource Settings: the Pop-Up Prevalence study with Private Ethics (PUPPE)
Version 1
: Received: 29 December 2023 / Approved: 2 January 2024 / Online: 3 January 2024 (02:06:58 CET)
How to cite:
Dolley, S. A Novel Feasibility Study Design Enabling Informative Clinical Trials in Low Resource Settings: the Pop-Up Prevalence study with Private Ethics (PUPPE). Preprints2024, 2024010020. https://doi.org/10.20944/preprints202401.0020.v1
Dolley, S. A Novel Feasibility Study Design Enabling Informative Clinical Trials in Low Resource Settings: the Pop-Up Prevalence study with Private Ethics (PUPPE). Preprints 2024, 2024010020. https://doi.org/10.20944/preprints202401.0020.v1
Dolley, S. A Novel Feasibility Study Design Enabling Informative Clinical Trials in Low Resource Settings: the Pop-Up Prevalence study with Private Ethics (PUPPE). Preprints2024, 2024010020. https://doi.org/10.20944/preprints202401.0020.v1
APA Style
Dolley, S. (2024). A Novel Feasibility Study Design Enabling Informative Clinical Trials in Low Resource Settings: the Pop-Up Prevalence study with Private Ethics (PUPPE). Preprints. https://doi.org/10.20944/preprints202401.0020.v1
Chicago/Turabian Style
Dolley, S. 2024 "A Novel Feasibility Study Design Enabling Informative Clinical Trials in Low Resource Settings: the Pop-Up Prevalence study with Private Ethics (PUPPE)" Preprints. https://doi.org/10.20944/preprints202401.0020.v1
Abstract
The design of randomized controlled trials for low-resource settings has unique challenges. One challenge is ensuring recruitment success in the face of a lack of information about prevalence of disease in the population. What disease burden data may exist is old and from distant regions, adding guesswork into site design. This leads to a high chance that the sample size will not be recruited in any reasonable timeframe—a challenge even in high-resource settings. While cross-sectional prevalence studies could be used as a type of feasibility study informing trials by generating near real-time prevalence estimates for the future trial site, such studies take years to complete. This duration makes insertion of such a study in trial design impossible. An empirically supported combination of new approaches that sidesteps unnecessary hurdles is presented, the Pop-Up Prevalence with Private Ethics (PUPPE) design. PUPPE includes using a COVID-validated, more targeted method of data collection, use of accepted ethics review from universities or hospitals to avoid lengthy public ethics review, and—if needed—post-study in silico participant randomization. Only this design would enable clinical trial designers to insert fit-for-purpose prevalence studies within the design phase of their trials, leading to informative outcomes.
Keywords
prevalence cross-sectional informativeness study design; randomized controlled; Study Design
Subject
Public Health and Healthcare, Other
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
