ArticleTrials2021
Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 10 citations in OpenAlex.
- IRB challenges in multisite studies: A case report and commentary from the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA).HRB open research · 2024Article
- Design, implementation, and inferential issues associated with clinical trials that rely on data in electronic medical records: a narrative review.BMC medical research methodology · 2023Review
- Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.JAMA network open · 2023Article
- Neuro-Urology and Biobanking: An Integrated Approach for Advancing Research and Improving Patient Care.International journal of molecular sciences · 2023Review
- Tau pathology in neurodegenerative disease: disease mechanisms and therapeutic avenues.The Journal of clinical investigation · 2023Review
- Pragmatic clinical trial design in emergency medicine: Study considerations and design types.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2022Article
- Extracting Significant Comorbid Diseases from MeSH Index of PubMed.Methods in molecular biology (Clifton, N.J.) · 2022Article
- The Recruitment Innovation Center: Developing novel, person-centered strategies for clinical trial recruitment and retention.Journal of clinical and translational science · 2021Article
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Authors and funding
10 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundNew considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated.
conclusionDevelopment of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.