25 Oct Cardiovascular Study Demonstrates Clinical Trial Data Sharing Is Feasible
Dr. Gay
MedicalResearch.com Interview with:
Hawkins C. Gay, MD, MPH
Resident Physician, Internal Medicine
Feinberg School of Medicine
Northwestern University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The National Academy of Medicine and other leading institutions have highlighted clinical trial data sharing as an important initiative for enhancing trust in the clinical research enterprise. More recently, the International Committee of Medical Journal Editors stipulated that manuscripts published in their journals must clearly state plans for data sharing in the trial’s registration, and the National Institutes of Health now requires a data sharing plan as part of new grant applications. Many clinical trialists rightly debate the costs and time required to curate their data into a format that is usable by third part data analysts. Similarly, there has been debate about the most efficient platforms from which to distribute this data, and different models exist, including governmental (NIH BioLINCC), commercial (ClinicalStudyDataRequest.com), and academic (Yale Open Access Data Project [YODA]) platforms.
Our study sought to explore these questions by conducting a reproduction analysis of the Thermocool Smarttouch Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial (NCT01385202), which is the only cardiovascular clinical trial available through the YODA platform. Reproduction analyses represent a fundamental approach for and outcome from data sharing but are uncommonly performed even though results change more than one-quarter of the time in reproduction analyses. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011.
The time from our initial proposal submission to YODA and the final analysis completion was 11 months. Freedom from atrial arrhythmias at 12 months post-procedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the two analyses. We could not reproduce all analyses that were conducted in the primary study report; specifically, the analyses relating to contact force range and regression models. The primary reason for non-reproducibility was missing or un-locatable data in the analyzable dataset.
MedicalResearch.com: What should readers take away from your report?
Response: We concluded that reproduction analyses are feasible and demonstrated the process and outcomes from a reproduction of the SMART-AF trial. Importantly, we identified key areas for improvement that will be important as the underlying methods and mechanisms for clinical trial data sharing continue to develop:
- Sharing statistical code may help to clarify technical and analytical processes and could reduce the burden of secondary requests placed to the original study authorship.
- Decentralized platforms (such as the NIH BioLINCC) likely improve data sharing efficiency and reduce the encumbrance on independent researchers compared with academically-hosted platforms.
- Allowing investigators to directly download data, rather than working between firewalls such as virtual desktop environments, could encourage increased use and output from data sharing platforms.
- Greater incentives may be important to encourage primary study authors to improve collaboration with independent researchers.
- Technology improvements will likely facilitate greater replication of original analytical environments and should be implemented as data sharing processes evolve.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The promise of data sharing is that it provides an avenue for producing unique and compelling clinical and translational insights. We encourage more investigators to utilize current sharing platforms to explore their clinical hypotheses. By publishing results, discussing benefits and limitations, and leveraging the lessons from these experiences we can maximize the impact of the clinical research enterprise.
Further investigation is needed to develop, implement, and evaluate meaningful incentives for collaboration between trialists and independent researchers, to identify the most appropriate funding sources to support trial sharing mechanisms, and to develop informatics advancements necessary to efficiently harmonize electronic data repositories.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: We thank original study authors and sponsor for sharing their data through the YODA platform and for working with the YODA Project to respond to our queries. We also thank the YODA Project and their representatives for their assistance and collaboration throughout this process.
Dr. Huffman receives support from the World Heart Federation to serve as its senior program advisor for the Emerging Leaders program, which is supported by unrestricted educational grants from Boehringer-Ingelheim and Novartis and has been previously supported by BUPA and AstraZeneca. Dr. Huffman is Associate Editor of JAMA Cardiology but was not involved in any of the decisions regarding review of the manuscript or its acceptance.
Citation:
JAMA Cardiol. 2017 Oct 18. doi: 10.1001/jamacardio.2017.3808. [Epub ahead of print]
Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing: A Reproduction Analysis of the SMART-AF Trial.
Gay HC1, Baldridge AS2, Huffman MD1,2,3
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on October 25, 2017 by Marie Benz MD FAAD