Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study.

Autor: Janda GS; Yale School of Medicine, New Haven, CT, USA., Jeffery MM; Division of Health Care Delivery Research, Mayo Clinic, Rochester, MN, USA., Ramachandran R; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT, USA., Ross JS; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA.; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA., Wallach JD; Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT, USA. joshua.wallach@emory.edu.; Department of Epidemiology, Rollins School of Public Health, Emory University, 1518 Clifton Road, Atlanta, GA, 30322, USA. joshua.wallach@emory.edu.
Jazyk: angličtina
Zdroj: BMC medical research methodology [BMC Med Res Methodol] 2024 Aug 28; Vol. 24 (1), pp. 187. Date of Electronic Publication: 2024 Aug 28.
DOI: 10.1186/s12874-024-02307-1
Abstrakt: Introduction: Real-world evidence is receiving considerable attention as a way to evaluate the efficacy and safety of medical products for substance use disorders (SUDs). However, the feasibility of using real-world data (RWD) to emulate clinical trials evaluating treatments for SUDs is uncertain. The aim of this study is to identify the number of clinical trials evaluating treatments for SUDs with reported results that could be feasibly emulated using observational data from contemporary insurance claims and/or electronic health record (EHR) data.
Methods: In this cross-sectional study, all phase 2-4 trials evaluating treatments for SUDs registered on ClinicalTrials.gov with reported results were identified. Each trial was evaluated to determine if the indications, interventions, at least 80% of eligibility criteria, comparators, and primary end points could be ascertained using contemporarily available administrative claims and/or structured EHR data.
Results: There were 272 SUD trials on ClinicalTrials.gov with reported results. Of these, when examining feasibility using contemporarily available administrative claims and/or structured EHR data, 262 (96.3%) had indications that were ascertainable; 194 (71.3%) had interventions that were ascertainable; 21 (7.7%) had at least 80% of eligibility criteria that were ascertainable; 17 (6.3%) had active comparators that were ascertainable; and 61 (22.4%) had primary end points that were ascertainable. In total, there were no trials for which all 5 characteristics were ascertainable using contemporarily available administrative claims and/or structured EHR data. When considering placebo comparators as ascertainable, there were 6 (2.2%) trials that had all 5 key characteristics classified as ascertainable from contemporarily available administrative claims and/or structured EHR data.
Conclusions: No trials evaluating treatments for SUDs could be feasibly emulated using contemporarily available RWD, demonstrating a need for an increase in the resolution of data capture within a public health system to facilitate trial emulation.
(© 2024. The Author(s).)
Databáze: MEDLINE
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