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CORBEL Data Sharing webinar slides

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Transparency and access to research data is a key feature of modern research policy, impacting data quality and the robustness of results, and allowing the optimal use of data generated by research projects.

Although the forms of open data access may vary across disciplines, the theme of data accountability and transparency applies broadly to any type of research activity. It is of particular importance for research receiving public funding. The debate around transparency in clinical trials involves additional factors (e.g. consent and protecting privacy) and many different stakeholders. Although various organisations have endorsed the principle of providing the scientific community with access to individual participant data from clinical trials, and several initiatives promote data sharing and have provided recommendations, a global consensus is needed.

Within the H2020-funded CORBEL project, ECRIN (the European Clinical Research Infrastructure Network) working with a large, international group of experts, produced a consensus document listing clear, broadly based and pragmatic recommendations supporting the sharing and reuse of individual-participant data from clinical trials.

CORBEL (http://www.corbel-project.eu) is an initiative of eleven new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research.

This webinar took place on 27th February 2018 and is part of the CORBEL webinar series. A recording of the webinar is available through the CORBEL website:
http://www.corbel-project.eu/webinars/data-sharing-from-clinical-trials.html

For previous and upcoming CORBEL webinars see:
http://www.corbel-project.eu/webinars

Published in: Healthcare
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CORBEL Data Sharing webinar slides

  1. 1. Data Sharing and Reuse from ClinicalTrials: Principles and Recommendations Presenters: Christian Ohmann (ECRIN-ERIC), Rita Banzi (Mario Negri), Steve Canham (ECRIN-ERIC) Host:Vera Matser (EMBL-EBI) 1 CORBEL Webinar Series http://www.corbel-project.eu/webinars
  2. 2. 2 This webinar is being recorded 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  3. 3. AUDIENCE Q&A SESSION 3 Please write your questions in the questions window of the GoToWebinar application 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  4. 4. BACKGROUND 4 Since 2015, thirteen ESFRI Research Infrastructures from the field of BioMedical Science (BMS RI) joined their scientific capabilities and services to transform the understanding of biological mechanisms and accelerate its translation into medical care. • biobanking & biomolecular resources • curated databases • marine model organisms • systems biology • translational research • functional genomics • screening & medicinal chemistry • microorganisms • clinical trials • structural biology • biological/medical imaging• plant phenotyping • highly pathogenic microorganisms 27/02/2018
  5. 5. CORBEL MISSION 5 Modern biological and biomedical research involves complex projects and a variety of different technologies. Some of the most important discoveries are made at the interface between different disciplines. CORBEL will harmonise access and services for complex research projects involving more than one RI that offer: • biological and medical technologies • biological samples and • data services 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  6. 6. TODAY’S PRESENTERS 6 Christian Ohmann, Mathematician by training, he received the habilitation inTheoretical Surgery and has over 30 years of experience in clinical trials and clinical research informatics, as Head of the Theoretical Surgery Unit at the Heinrich-Heine- University of Düsseldorf first and then as Scientific Head of the Coordination Centre for ClinicalTrials in the same University, until 2014. Retired, he is now working for the European Clinical Research Infrastructures Network (ECRIN) as a chair of Network Committee and chair of Independent Certification Board; he also represents ECRIN in several H2020 funded projects such as CORBEL. 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  7. 7. TODAY’S PRESENTERS 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations 7 Rita Banzi is the Coordinator of the Centre for Drug Regulatory Policies at the Mario Negri Institute in Milan. She received her BS in Pharmaceutical Chemistry from the University of Bologna and completed her PhD in Pharmaceutical Sciences at the same University. She’s been working at Mario Negri since 2007 as staff of the Italian Cochrane Centre for the development of systematic reviews and ECRIN European Correspondent for Italy. She has an extensive experience and expertise in clinical research, systematic review methodology and appraisal of mechanisms of marketing approvals of drugs in Europe.
  8. 8. TODAY’S PRESENTERS 8 Steven Canham, IT consultant specializing in clinical trial data systems and data management, with 16 years' experience with clinical research systems. From 2002 - 2011 he was the Head of the IT team at the trials unit at the Institute of Cancer Research, London. He is currently Secretary to the ECRIN Independent Certification Board for data centres, Chair of ECRIN standards review, ECRIN auditor and member of the UK's international Registration Panel for clinical trials units. Steve is also involved in several H2020 projects on behalf of ECRIN. 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  9. 9. 9 Waste in research Efficiency of knowledge generation Transparency/open science/FAIR CLINICALTRIAL DATA SHARING AND REUSE CULTURAL CHANGE 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  10. 10. 10 CLINICALTRIAL DATA SHARING AND REUSE STAKEHOLDER ENGAGEMENT 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  11. 11. 11 • reduce unnecessary duplication of studies and costs of future studies • reduce exposure of participants in future trials to avoidable harms • lead to new hypothesis about mechanisms of disease and more effective therapies to be tested in additional research • better evidence on the safety and effectiveness of therapies for patients • better evidence allows health care professionals and patients to more informed decisions about health clinical care CLINICALTRIAL DATA SHARING AND REUSE POTENTIAL BENEFIT* *IOM. 2015: Sharing clinical trial data: Maximizing benefis, minimizing risk. Washington, DC. National Academics Press 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  12. 12. 12 • participant privacy • unfair commercial use • invalid secondary analyses • no credit for clinical trialists/sponsors • other risks *IOM. 2015: Sharing clinical trial data: Maximizing benefis, minimizing risk. Washington, DC. National Academics Press CLINICALTRIAL DATA SHARING AND REUSE POTENTIAL RISKS* 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  13. 13. 13 • MRC, UKCRC, CRU, Wellcome: Good practice principles for sharing IPD from publicly funded clinical trials (Tudor Smith et al., April 2015) • MRCT, Wellcome, Arnold: Launch of data sharing working groups 2015 (based on workshop, Harvard, 30-31, March 2015) • Wellcome: Assessing the research potential of access to clinical trial data.A report to the Wellcome Trust (Varnai et al.,Technopolis Group, 2014) • Institute of Medicine: Sharing clinical trial data: maximizing benefts, minimizing risk (IOM, 2015) • NordicTrial Alliance Group: Transparency and registration in Clinical Research in the Nordic Countries (2015) CLINICALTRIAL DATA SHARING AND REUSE RECOMMENDATIONS AND POLICIES 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  14. 14. 14 CLINICALTRIAL DATA SHARING AND REUSE WHAT IS AVAILABLE ANDWHAT IS NEEDED • What is available Open and published policies and recommendations embedded in - geographical/national context (e.g. US, UK, Nordic countries) - centred on a specific stakeholder group (e.g. pharmaceutical industry) - centred on a specific subset of clinical trial data (e.g. ICMJE – published data) • What is needed Up to date, precise, broadly based and workable recommendations supporting data sharing from clinical trials with - focus on non-commercial trials, - European origin - perspective of the researcher 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  15. 15. Meta-analysis Trial methodology Univ. Copenhagen (C. Gluud) Univ. Liverpool (C.Tudor Smith) Transparency/registration WHO ICTRP (G. Karam) Ottawa Group (K. Krleza-Jeric) EQUATOR (P. Ravaud) MRCT Harvard (B. Bierer) Funders NCI (J. Galvez) UK MRC (R. Knowles) NHMRC (D. Ghersi) Wellcome (J. O‘Callaghan) ECRIN (S. Battaglia, C. Kubiak, M. Matei, J. Demotes, C. Ohmann) 15 CLINICALTRIAL DATA SHARING AND REUSE MULTI-STAKEHOLDERTASKFORCE Publishers BMJ (T. Groves) BMC (D. Shanahan; H. Faure) Regulatory bodies EMA (M. Dias) Patient organisations EATG (P. Marques) Ethics Univ.Vienna (C. Druml) Sanger (S. Bowers/C. Smee) Data protection MedConsult (E. vanVeen) TMF (I. Schluender) IT-experts ECRIN (S. Canham) EBI (D. Spalding) EUDAT (A. Lukkarinen, C. Ariyo) Univ. Düsseldorf (W. Kuchinke) Mario Negri (R. Banzi, L. Clivio) Standardisation bodies CDISC (P. Houston, R. Kush, L. Becnel, P. van Reusel) Glob. All. Gen.Health (J. Wilson) EHR4CR (D. Kalra) DataCite (M. Fenner) IT-/service provider Medidata/TrialGrid (A. Newbigging) Trial Data Solutions (G. Rienk) Consensus expert Univ. Marburg (H. Sitter) 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  16. 16. 16 CLINICALTRIAL DATA SHARING AND REUSE CONSENSUS PROCESS Aim: Development of a consensus document on providing access to individual participant data from clinical trials by a multi- stakeholder taskforce Method: Group Nominal Process with three workshops and written feedback - 4 March 2016 (Paris), 6-7 October 2016 (Milano), - 27-28 March 2017 (Paris) Results: Consensus document with 10 principles and 50 recommendations 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  17. 17. CORBEL CONSENSUS PROCESS OUTPUT 17 Promotion, incentives, resources Explicit broad consent to sharing and re-use De-identification pseudo- anonymised data Data structured, described and formatted in standard ways to promote inter-operability  As open as possible, as closed as necessary to protect privacy and reduce misuse  Explicit, reproducible, and transparent process  Access to data and data objects  Data repositories Metadata to promote discoverability 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  18. 18. P1: MAKE DATA SHARING A REALITY 18 The provision of individual-participant data should be promoted, incentivised and resourced so that it becomes the norm in clinical research. Plans for data sharing should be described prospectively, and be part of study development from the earliest stages. Culture and environment 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  19. 19. 19 Different stakeholders recognize data sharing as good practice Data stewardship and data ownership Institutional policies to promote data sharing Data sharing prospectively planned Standards and template Academic and societal rewards and incentives for data sharing Systems to monitor compliance to plans Financial models to support data preparation, storage and sharing Discoverabili ty and Citability of datasets P1: MAKE DATA SHARING A REALITY 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  20. 20. P2: CONSENT FOR DATA SHARING 20 Individual-participant data sharing should be based on explicit broad consent by trial participants to the sharing and reuse of their data for scientific purposes. Information and awareness 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  21. 21. 21 Explicit consent to share and re- use of data Consent to sharing data/ consent to participation: separate but concurrent Consent as broad as possible (for scientific purposes) Information on reasons for sharing and benefit Right to withdrawn, practical difficulties explained Information on data preparation, storage and access mechanisms Clear and concise language P2: CONSENT FOR DATA SHARING 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  22. 22. P5, 6, 7: RIGHTS,TYPES, AND MANAGEMENT OF ACCESS 22 • P5: Access to individual-participant data and trial documents should be as open as possible and as closed as necessary, to protect participant privacy and reduce the risk of data misuse. • P6: In the context of managed access, any citizen or group that has both a reasonable scientific question and the expertise to answer that question should be able to request access to individual-participant data and trial documents. • P7:The processing of data access requests should be explicit, reproducible, and transparent but, so far as possible, should minimise the additional bureaucratic burden on all concerned. Governance of access 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  23. 23. 23 Range of access types (no one-size- fit all) Compliance with basic rules to ensure a fair data sharing Board overseeing data sharing Right to request data not limited to specific professions or roles Friendly interfaces to request and access to data Transparency of methods and results of secondary analysis Data use agreement P5, 6, 7: RIGHTS,TYPES, AND MANAGEMENT Data generator and data users may collaborate (or not) Metrics of access and reuse of data 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  24. 24. 24 P3: PROTECTION OFTRIAL PARTICIPANTS 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations IPD made available for sharing should be prepared for that purpose, with de-identification of data sets to minimise the risk of reidentification.The de-identification steps that are applied should be recorded.
  25. 25. 2527/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations P3: PROTECTION OFTRIAL PARTICIPANTS Before being shared, data should be de- identified Shared data should be pseudonymous where possible Attempted reidentification should be forbidden Standard techniques to be applied & documented Residual risks should be assessed & documented No consent: data sharing *may* be possible Services to support data preparation
  26. 26. 26 P4: DATA STANDARDS 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations To promote interoperability and retain meaning within interpretation and analysis, shared data should, as far as possible, be structured, described and formatted using widely recognised data and metadata standards.
  27. 27. 2727/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations P4: DATA STANDARDS Data and coding standards built in from the outset Start with the CDISC standards Descriptive metadata required for all datasets Become familiar with data standards Help to develop data standards Use standardised file formats
  28. 28. 28 P8, 9: DATA MANAGEMENT AND REPOSITORIES 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations • P8: Besides the IPD data sets, other clinical trial data objects should be made available for sharing (e.g., protocols, clinical study reports, statistical analysis plans, blank consent forms) to allow a full understanding of any data set. • P9: Data and trial documents made available for sharing should be transferred to a suitable data repository to help ensure that the data objects are properly prepared, are available in the longer term, are stored securely and are subject to rigorous governance.
  29. 29. 2927/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations P8, 9: DATA MANAGEMENT AND REPOSITORIES Repositories should be compliant with quality criteria Information on different repositories made available Temporary import of data from different sources Formal data transfer agreements needed Analysis environments required? Facilities to analyse and document
  30. 30. 30 P10: DISCOVERABILITY AND METADATA 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations Any data set or document made available for sharing should be associated with concise, publicly available and consistently structured discovery metadata, describing not just the data object itself but also how it can be accessed.This is to maximise its discoverability by both humans and machines.
  31. 31. 31 P10: DISCOVERABILITY AND METADATA 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations We need a metadata schema for discoverability Persuade repositories to use it or a mappable system Tools required to harvest the metadata Identifiers (DOIs) need to be applied to all data objects Tools required to help apply the metadata A metadata repository, single portal access Long term sustainability required
  32. 32. THE PAPER 32 doi:10.1136/bmjopen-2017-018647 27/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations
  33. 33. THE NEXT STEPS 3327/02/2018Data Sharing and Reuse from Clinical Trials: Principles and Recommendations Under discussion, but should probably include… Providing general background material Developing example documents, e.g. data use agreements Develop a metadata repository (or at least a pilot) Provide resource locator services (e.g. for data standards) Develop repository standards List available repositories Establish a metadata schema Developing example processes, e.g. SOPs on data sharing Develop IT tools, e.g. to assign metadata Try to ensure full citation of data use Establish services, e.g. for de- identification Collect example templates, checklists
  34. 34. Questions? Data Sharing and Reuse from ClinicalTrials: Principles and Recommendations Presenters: Christian Ohmann (ECRIN-ERIC), Rita Banzi (Mario Negri), Steve Canham (ECRIN-ERIC) Host:Vera Matser (EMBL-EBI) 14/05/2018footer 34
  35. 35. NEXT WEBINAR 35 Title: Single sign-on for Life Science services Speakers: Mikael Linden, Kostas Koumantaros Date:Tue 17th April, 2018 Time: 14:30 CET Registration and details http://www.corbel-project.eu/webinars

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