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The Spine Blog
Thursday, January 02, 2014
3 Lessons from the YODA-Medtronic Open Science Effort

One of the big stories in spine surgery in 2013 was the controversy over rhBMP-2, which not only helped clarify what could be known about the agent from existing trials but had showed the value of open science.  Medtronic (Minneapolis, Minnesota) made their rhBMP-2 clinical trial assets available to independent scientists and set an example for others to follow. As we reflect on the experience we believe that there are (at least) 3 lessons that grew out of the work that go beyond the specifics of rhBMP-2.

1.       Reproducing studies can produce valuable insights. Though the YODA reviews [1-2] produced broadly similar results, there were important differences in methodology and results for fusion and cancer risk. Similarly skilled groups looking at the same data can come to reasonable differences in conclusions, so making data available for re-analysis can add to scientific understanding.

2.       Learning to share is hard work. There are legitimate concerns from industry, academia, and patients that must be overcome to make data sharing practical. The YODA Project has tried to alleviate some industry concerns over spurious secondary analyses but de-identifying patient data and preparing data for other investigators is still labor intensive. Academia must also work toward norms of both sharing data and sharing recognition for making data available.

3.       Open science is an open process. The YODA Project provides one model for sharing individual patient level trial data. Additional efforts are now being made by regulatory agencies like the European Medicines Agency (EMA) [3] as well as industry organizations including the Pharmaceutical Research Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) [4-5].

 

Jeffrey B. Low, AB; Joseph S. Ross, MD, MHS; Harlan M. Krumholz, MD, SM

References

1.       Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, et al. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion. A systematic review and meta-analysis. Ann Intern Med. 2013; 158:890-902.

2.       Simmonds MC, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Rodgers MA, et al. Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion. A meta-analysis of individual-participant data. Ann Intern Med. 2013; 158:877-89.

3.       European Medicines Agency. Release of data from clinical trials. Accessed at http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000555.jsp on 20 Dec 2013.

4.       Pharmaceutical Research and Manufacturers of America and European Federation of Pharmaceutical Industries and Associations. Principles for Responsible Clinical Trial Data Sharing. 18 Jul 2013.

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Spine Journal
This Blog provides a forum for discussion about high impact articles published in Spine, including the bi-annual publication of "Evidenced-Based Recommendations for Spine Surgery." Website users can use this forum to discuss how the articles have affected their practice and query the authors about their findings and recommendations.