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BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2020

Open Access 01-12-2020 | Research article

Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide

Authors: Matthew Ventresca, Holger J. Schünemann, Fergus Macbeth, Mike Clarke, Lehana Thabane, Gareth Griffiths, Simon Noble, David Garcia, Maura Marcucci, Alfonso Iorio, Qi Zhou, Mark Crowther, Elie A. Akl, Gary H. Lyman, Viktoria Gloy, Marcello DiNisio, Matthias Briel

Published in: BMC Medical Research Methodology | Issue 1/2020

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Abstract

Background

Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations.

Methods

We systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD.

Results

Our scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed.
For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues.

Conclusions

Knowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing.
Appendix
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Literature
1.
Clarke MJ. Individual patient data meta-analyses. Best Pract Res Clin Obstet Gynaecol. 2005;19(1):47–55.CrossRefPubMed
2.
Cooper HM, Hedges LV, Valentine JC. The handbook of research synthesis and meta-analysis. 2nd ed. New York: Russell Sage Foundation xvi; 2009. p. 615.
3.
Riley RD, Simmonds MC, Look MP. Evidence synthesis combining individual patient data and aggregate data: a systematic review identified current practice and possible methods. J Clin Epidemiol. 2007;60(5):431–9.CrossRefPubMed
4.
Riley RD, Lambert PC, Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ. 2010;340:c221.CrossRefPubMed
5.
Simmonds MC, et al. Meta-analysis of individual patient data from randomized trials: a review of methods used in practice. Clin Trials. 2005;2(3):209–17.CrossRefPubMed
6.
Tudur Smith C, et al. Individual participant data meta-analyses compared with meta-analyses based on aggregate data [abstract]. Trials. 2011;12:21–2.CrossRef
7.
Stewart LA, Clarke MJ. Practical methodology of meta-analyses (overviews) using updated individual patient data. Cochrane Working Group. Stat Med. 1995;14(19):2057–79.CrossRefPubMed
8.
Stewart LA, Tierney JF. To IPD or not to IPD? Advantages and disadvantages of systematic reviews using individual patient data. Eval Health Prof. 2002;25(1):76–97.CrossRefPubMed
9.
Tudur Smith C, et al. Individual participant data meta-analyses compared with meta-analyses based on aggregate data. Cochrane Database Syst Rev. 2016;9:MR000007.PubMed
10.
11.
Mello MM, et al. Preparing for responsible sharing of clinical trial data. N Engl J Med. 2013;369(17):1651–8.CrossRefPubMed
12.
Stewart LA, T.J., Clarke M. Chapter 18: Reviews of individual patient data. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011; Available from: www.​handbook.​cochrane.​org.
13.
Vale CL, et al. Uptake of systematic reviews and meta-analyses based on individual participant data in clinical practice guidelines: descriptive study. BMJ. 2015;350:h1088.PubMedCentralCrossRefPubMed
14.
Tierney JF, et al. How individual participant data meta-analyses have influenced trial design, conduct, and analysis. J Clin Epidemiol. 2015;68(11):1325–35.PubMedCentralCrossRefPubMed
15.
Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Cochrane, 2019. Available from www.​training.​cochrane.​org/​handbook.
16.
Nevitt SJ, et al. Exploring changes over time and characteristics associated with data retrieval across individual participant data meta-analyses: systematic review. BMJ. 2017;357:j1390.PubMedCentralCrossRefPubMed
17.
18.
19.
Ahmed I, Sutton AJ, Riley RD. Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey. BMJ. 2012;344:d7762.CrossRefPubMed
20.
21.
Sutton AJ, Kendrick D, Coupland CA. Meta-analysis of individual- and aggregate-level data. Stat Med. 2008;27(5):651–69.CrossRefPubMed
22.
Abo-Zaid G, Sauerbrei W, Riley RD. Individual participant data meta-analysis of prognostic factor studies: state of the art? BMC Med Res Methodol. 2012;12:56.PubMedCentralCrossRefPubMed
23.
24.
25.
26.
27.
28.
Barnhart KT, Legro RS, Scott RT Jr. Data sharing requirements: perspectives from three authors. Fertil Steril. 2018;109(1):44–7.CrossRefPubMed
29.
Sardanelli F, et al. To share or not to share? Expected pros and cons of data sharing in radiological research. Eur Radiol. 2018;28(6):2328–35.CrossRefPubMed
30.
Wu T, et al. Transparency and sharing individual participant data of clinical trials: a philosophical proposition about the medical study ethics and implications for clinical trials. [Chinese]. Chin J Evid Based Med. 2018;18(6):538–42.
31.
32.
Bell EA, Ohno-Machado L, Grando MA. Sharing my health data: a survey of data sharing preferences of healthy individuals. AMIA Annu Symp Proc. 2014;2014:1699–708.PubMedCentralPubMed
33.
Cheah PY, et al. Perceived benefits, harms, and views about how to share data responsibly: a qualitative study of experiences with and attitudes toward data sharing among Research staff and community representatives in Thailand. J Empir Res Hum Res Ethics. 2015;10(3):278–89.PubMedCentralCrossRefPubMed
34.
Howe N, et al. Systematic review of participants’ attitudes towards data sharing: a thematic synthesis. J Health Serv Res Policy. 2018;23(2):123–33.CrossRefPubMed
35.
36.
37.
38.
Taichman DB, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. PLoS Med. 2017;14(6):e1002315.PubMedCentralCrossRefPubMed
39.
40.
Kiley R, et al. Data sharing from clinical trials - a Research Funder's perspective. N Engl J Med. 2017;377(20):1990–2.CrossRefPubMed
41.
42.
Godlee F, Groves T. The new BMJ policy on sharing data from drug and device trials. BMJ. 2012;345:e7888.CrossRefPubMed
43.
44.
45.
46.
47.
48.
Atzor S, et al. Clinical trial data sharing: from principles to practical implementation - an industry model. Regul Rapporteur. 2014;11(4):4–7.
49.
Lo B. Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA. 2015;313(8):793–4.CrossRefPubMed
50.
O'Dowd A. Drug industry pledge on access to trial data is met with scepticism. BMJ. 2013;347:f4829.CrossRefPubMed
51.
Doshi P. EFPIA-PhRMA's principles for clinical trial data sharing have been misunderstood. BMJ. 2013;347:f5164.CrossRefPubMed
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76.
77.
Schunemann HJ, et al. Use of heparins in patients with cancer: individual participant data meta-analysis of randomised trials study protocol. BMJ Open. 2016;6(4):e010569.PubMedCentralCrossRefPubMed
78.
79.
Tricco AC, et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. 2018;169(7):467–73.CrossRefPubMed
80.
81.
82.
83.
84.
85.
86.
87.
Nisen P, Rockhold F. Access to patient-level data from GlaxoSmithKline clinical trials. N Engl J Med. 2013;369(5):475–8.CrossRefPubMed
88.
89.
90.
91.
92.
93.
94.
95.
96.
97.
98.
99.
100.
101.
Pencina MJ, et al. Supporting open access to clinical trial data for researchers: the Duke Clinical Research Institute-Bristol-Myers Squibb supporting open access to researchers initiative. Am Heart J. 2016;172:64–9.CrossRefPubMed
102.
103.
104.
105.
106.
107.
108.
109.
110.
111.
112.
113.
114.
115.
116.
117.
118.
119.
120.
121.
122.
123.
124.
EMD Serono. Summary of EMD Serono's responsible data sharing policy. [cited 2019 March 22].
125.
126.
127.
128.
Berlin JA, et al. Bumps and bridges on the road to responsible sharing of clinical trial data. Clin Trials. 2014;11(1):7–12.CrossRefPubMed
129.
Polanin JR. Efforts to retrieve individual participant data sets for use in a meta-analysis result in moderate data sharing but many data sets remain missing. J Clin Epidemiol. 2018;98:157–9.CrossRefPubMed
130.
Polanin JR, Terzian M. A data-sharing agreement helps to increase researchers’ willingness to share primary data: results from a randomized controlled trial. J Clin Epidemiol. 2019;106:60–9.CrossRefPubMed
131.
Polanin JR, Williams RT. Overcoming obstacles in obtaining individual participant data for meta-analysis. Res Synth Methods. 2016;7(3):333–41.CrossRefPubMed
132.
133.
134.
Young T, Hopewell S. Methods for obtaining unpublished data. Cochrane Database Syst Rev. 2011;11:MR000027.
135.
Lefebvre C, M.E., Glanville J. Chapter 6: Searching for studies In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011; Available from: www.​handbook.​cochrane.​org.
136.
137.
Veroniki AA, et al. Retrieval of individual patient data depended on study characteristics: a randomized controlled trial. J Clin Epidemiol. 2019;113:176–88.CrossRefPubMed
138.
139.
140.
141.
142.
143.
144.
145.
146.
Hopkins AM, Rowland A, Sorich MJ. Data sharing from pharmaceutical industry sponsored clinical studies: Audit of data availability. BMC Med. 2018;16(1):1154.CrossRef
147.
148.
149.
150.
Doshi P, Goodman SN, Ioannidis JP. Raw data from clinical trials: within reach? Trends Pharmacol Sci. 2013;34(12):645–7.CrossRefPubMed
151.
152.
Ross JS, Krumholz HM. Ushering in a new era of open science through data sharing: the wall must come down. JAMA. 2013;309(13):1355–6.CrossRefPubMed
153.
154.
Nimh Collaborative Data Synthesis for Adolescent Depression Trials Study Team including, et al. Advancing Science Through Collaborative Data Sharing and Synthesis. Perspect Psychol Sci. 2013;8(4):433–44.CrossRef
155.
156.
Bierer BE, Crosas M, Pierce HH. Data authorship as an incentive to data sharing. N Engl J Med. 2017;377(4):402.CrossRefPubMed
157.
Berman F, Cerf V. Science priorities. Who will pay for public access to research data? Science. 2013;341(6146):616–7.CrossRefPubMed
158.
Wilhelm EE, Oster E, Shoulson I. Approaches and costs for sharing clinical research data. JAMA. 2014;311(12):1201–2.CrossRefPubMed
159.
160.
Naudet F, et al. Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: Survey of studies published in the BMJ and PLOS Medicine. BMJ. 2018;360:k400.PubMedCentralCrossRefPubMed
161.
162.
163.
164.
165.
166.
167.
Mazor KM, et al. Stakeholders’ views on data sharing in multicenter studies. J Comp Eff Res. 2017;6(6):537–47.CrossRefPubMed
168.
169.
170.
Bull S, Roberts N, Parker M. Views of ethical best practices in sharing individual-level data from medical and public Health Research: a systematic scoping review. J Empir Res Hum Res Ethics. 2015;10(3):225–38.PubMedCentralCrossRefPubMed
171.
Rowhani-Farid A, Allen M, Barnett AG. What incentives increase data sharing in health and medical research? A systematic review. Res Integr Peer Rev. 2017;2:4.PubMedCentralCrossRefPubMed
172.
Kim Y. Fostering scientists’ data sharing behaviors via data repositories, journal supplements, and personal communication methods. Inf Process Manag. 2017;53(4):871–85.CrossRef
173.
Hopkins C, et al. UK publicly funded clinical trials units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol. 2016;70:17–25.PubMedCentralCrossRefPubMed
174.
Learned K, Durbin A, Currie R, Beale H, Lam DL, Goldstein T, Salama SR, Haussler D, Morozova O, Bjork I. A critical evaluation of genomic data sharing: Barriers to accessing pediatric cancer genomic datasets: a Treehouse Childhood Cancer Initiative experience [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017. Washington, DC. Philadelphia (PA): AACR; Cancer Res. 2017;77(13 Suppl):Abstract nr LB-338. https://​doi.​org/​10.​1158/​1538-7445.​AM2017-LB-338.
175.
Simmonds M, Stewart G, Stewart L. A decade of individual participant data meta-analyses: A review of current practice. Contemp Clin Trials. 2015;45(Pt A):76–83.CrossRefPubMed
176.
177.
Rogozinska E, et al. Meta-analysis using individual participant data from randomised trials: opportunities and limitations created by access to raw data. Evidence-Based Med. 2017;22(5):157–62.CrossRef
178.
Stewart LA, et al. Preferred reporting items for systematic review and meta-analyses of individual participant data: the PRISMA-IPD statement. JAMA. 2015;313(16):1657–65.CrossRefPubMed
179.
180.
SAS Institute, Multi-Sponsor Environment - SAS® Clinical Trial Data Transparency Version 2.3 User Guide. 2018.
181.
182.
Mospan GA, Wargo KA. Researchers’ experience with clinical data sharing. J Am Board Fam Med. 2016;29(6):805–7.CrossRefPubMed
183.
184.
Aitken M, et al. Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies. BMC Med Ethics. 2016;17(1):73.PubMedCentralCrossRefPubMed
185.
Hughes S, et al. Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach. Pharm Stat. 2014;13(3):179–83.CrossRefPubMed
186.
Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, and Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington (DC): National Academies Press (US); 2015 Appendix B, Concepts and Methods for De-identifying Clinical Trial Data]. Available from: https://​www.​ncbi.​nlm.​nih.​gov/​books/​NBK285994/​.
187.
188.
Tierney JF, et al. Individual participant data (IPD) meta-analyses of randomised controlled trials: guidance on their use. PLoS Med. 2015;12(7):e1001855.PubMedCentralCrossRefPubMed
189.
190.
191.
192.
Simmonds MC, 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(12):877–89.CrossRefPubMed
193.
Fu 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(12):890–902.CrossRefPubMed
194.
Krumholz HM, et al. A historic moment for open science: the Yale University open data access project and medtronic. Ann Intern Med. 2013;158(12):910–1.PubMedCentralCrossRefPubMed
195.
Hrobjartsson A. Why did it take 19 months to retrieve clinical trial data from a non-profit organisation? BMJ. 2013;347:f6927.CrossRefPubMed
196.
197.
Filippon J. Slow and costly access to anonymised patient data impedes academic research. BMJ. 2015;351:h5087.CrossRefPubMed
198.
Tudur Smith C, et al. Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository. PLoS One. 2014;9(5):e97886.PubMedCentralCrossRefPubMed
199.
Huser V, Shmueli-Blumberg D. Data sharing platforms for de-identified data from human clinical trials. Clinical Trials. 2018;15(4):413–23.CrossRefPubMed
200.
So D, Knoppers BM. Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com. PLoS One. 2017;12(9):e0184491.PubMedCentralCrossRefPubMed
201.
202.
203.
Eichler HG, Sweeney F. The evolution of clinical trials: Can we address the challenges of the future? Clin Trials. 2018;15(1_suppl):27–32.CrossRefPubMed
204.
Khusro A, Aarti C. TB-PACTS: a fresh emphatic data sharing approach. Asian Pac J Trop Dis. 2017;7(2):97–8.CrossRef
205.
Bertagnolli MM, et al. Advantages of a truly open-access data-sharing model. N Engl J Med. 2017;376(12):1178–81.CrossRefPubMed
206.
Asare AL, et al. Clinical trial data access: opening doors with TrialShare. J Allergy Clin Immunol. 2016;138(3):724–6.CrossRefPubMed
207.
Zinner DE, Pham-Kanter G, Campbell EG. The changing nature of scientific sharing and withholding in academic life sciences Research: trends from National Surveys in 2000 and 2013. Acad Med. 2016;91(3):433–40.PubMedCentralCrossRefPubMed
208.
209.
Strom BL, et al. Data sharing - is the juice worth the squeeze? N Engl J Med. 2016;375(17):1608–9.CrossRefPubMed
210.
Bonini S, et al. Transparency and the European medicines agency--sharing of clinical trial data. N Engl J Med. 2014;371(26):2452–5.CrossRefPubMed
211.
Drazen JM. Sharing individual patient data from clinical trials. N Engl J Med. 2015;372(3):201–2.CrossRefPubMed
212.
International Consortium of Investigators for Fairness in Trial Data, S, et al. Toward Fairness in Data Sharing. N Engl J Med. 2016;375(5):405–7.CrossRef
213.
Navar AM, Pencina MJ, Peterson ED. Open access platforms for sharing clinical trial data--reply. JAMA. 2016;316(6):666–7.CrossRefPubMed
214.
Ross JS, Krumholz HM. Open access platforms for sharing clinical trial data. JAMA. 2016;316(6):666.CrossRefPubMed
215.
216.
Garrison NA, et al. A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States. Genet Med. 2016;18(7):663–71.CrossRefPubMed
217.
218.
219.
220.
Metadata
Title
Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide
Authors
Matthew Ventresca
Holger J. Schünemann
Fergus Macbeth
Mike Clarke
Lehana Thabane
Gareth Griffiths
Simon Noble
David Garcia
Maura Marcucci
Alfonso Iorio
Qi Zhou
Mark Crowther
Elie A. Akl
Gary H. Lyman
Viktoria Gloy
Marcello DiNisio
Matthias Briel
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2020
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/s12874-020-00964-6

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