Sea Change in Open Science and Data Sharing
2014; Lippincott Williams & Wilkins; Volume: 7; Issue: 4 Linguagem: Inglês
10.1161/circoutcomes.114.001166
ISSN1941-7705
AutoresHarlan M. Krumholz, Cary P. Gross, Katrina L. Blount, Jessica Ritchie, Beth Hodshon, Richard Lehman, Joseph S. Ross,
Tópico(s)Meta-analysis and systematic reviews
ResumoHomeCirculation: Cardiovascular Quality and OutcomesVol. 7, No. 4Sea Change in Open Science and Data Sharing Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBSea Change in Open Science and Data SharingLeadership by Industry Harlan M. Krumholz, MD, SM, Cary P. Gross, MD, Katrina L. Blount, PhD, Jessica D. Ritchie, MPH, Beth Hodshon, JD, MPH, RN, Richard Lehman, MRCGP and Joseph S. Ross, MD, MHS Harlan M. KrumholzHarlan M. Krumholz From the Section of Cardiovascular Medicine (H.M.K., B.H., K.L.B.), Robert Wood Johnson Foundation Clinical Scholars Program (H.M.K., C.P.G., J.S.R.), and Section of General Internal Medicine (C.P.G., J.S.R.), Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (H.M.K.); Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, CT (H.M.K., J.D.R.); and Oxford University Department of Primary Care Health Sciences (Senior Research Fellow), United Kingdom (R.L.). , Cary P. GrossCary P. Gross From the Section of Cardiovascular Medicine (H.M.K., B.H., K.L.B.), Robert Wood Johnson Foundation Clinical Scholars Program (H.M.K., C.P.G., J.S.R.), and Section of General Internal Medicine (C.P.G., J.S.R.), Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (H.M.K.); Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, CT (H.M.K., J.D.R.); and Oxford University Department of Primary Care Health Sciences (Senior Research Fellow), United Kingdom (R.L.). , Katrina L. BlountKatrina L. Blount From the Section of Cardiovascular Medicine (H.M.K., B.H., K.L.B.), Robert Wood Johnson Foundation Clinical Scholars Program (H.M.K., C.P.G., J.S.R.), and Section of General Internal Medicine (C.P.G., J.S.R.), Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (H.M.K.); Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, CT (H.M.K., J.D.R.); and Oxford University Department of Primary Care Health Sciences (Senior Research Fellow), United Kingdom (R.L.). , Jessica D. RitchieJessica D. Ritchie From the Section of Cardiovascular Medicine (H.M.K., B.H., K.L.B.), Robert Wood Johnson Foundation Clinical Scholars Program (H.M.K., C.P.G., J.S.R.), and Section of General Internal Medicine (C.P.G., J.S.R.), Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (H.M.K.); Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, CT (H.M.K., J.D.R.); and Oxford University Department of Primary Care Health Sciences (Senior Research Fellow), United Kingdom (R.L.). , Beth HodshonBeth Hodshon From the Section of Cardiovascular Medicine (H.M.K., B.H., K.L.B.), Robert Wood Johnson Foundation Clinical Scholars Program (H.M.K., C.P.G., J.S.R.), and Section of General Internal Medicine (C.P.G., J.S.R.), Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (H.M.K.); Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, CT (H.M.K., J.D.R.); and Oxford University Department of Primary Care Health Sciences (Senior Research Fellow), United Kingdom (R.L.). , Richard LehmanRichard Lehman From the Section of Cardiovascular Medicine (H.M.K., B.H., K.L.B.), Robert Wood Johnson Foundation Clinical Scholars Program (H.M.K., C.P.G., J.S.R.), and Section of General Internal Medicine (C.P.G., J.S.R.), Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (H.M.K.); Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, CT (H.M.K., J.D.R.); and Oxford University Department of Primary Care Health Sciences (Senior Research Fellow), United Kingdom (R.L.). and Joseph S. RossJoseph S. Ross From the Section of Cardiovascular Medicine (H.M.K., B.H., K.L.B.), Robert Wood Johnson Foundation Clinical Scholars Program (H.M.K., C.P.G., J.S.R.), and Section of General Internal Medicine (C.P.G., J.S.R.), Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT (H.M.K.); Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, CT (H.M.K., J.D.R.); and Oxford University Department of Primary Care Health Sciences (Senior Research Fellow), United Kingdom (R.L.). Originally published2 Jun 2014https://doi.org/10.1161/CIRCOUTCOMES.114.001166Circulation: Cardiovascular Quality and Outcomes. 2014;7:499–504Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2014: Previous Version 1 With remarkable speed, the landscape of open science and data sharing is changing. Fueled by recent evidence that the results of many clinical trials of interventions in common use are never published or reported and that these studies are not missing at random, a persuasive argument has been made that all data from human trials should be available to inform clinical practice.1–6 This would also promote higher quality and higher integrity science, although some urge caution as a result of concerns about unintended adverse consequences.7In response to these calls for action, some companies have stepped forward and demonstrated leadership. GlaxoSmithKline, in coordination with other companies such as Roche and ViiV, committed early to data sharing.8 Medtronic contracted with our research team, the Yale University Open Data Access Project,9 to conduct external reviews of its clinical trial data for a single product. In addition, we developed policies and procedures to share these data with other investigators. Importantly, Medtronic fully transferred the decision-making authority on how to share the data and who could receive the data to the Yale University Open Data Access Project. Janssen, the pharmaceutical companies of Johnson & Johnson, has now contracted to do the same for the trials under its auspices. Increasingly, other companies are announcing their intention to share data from all published and unpublished clinical trials.On July 24, 2013, the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America publicly announced the commitment of their member companies to share clinical trial data and results. Specifically, member companies would share patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union with qualified scientific and medical researchers on request and subject to terms necessary to protect patient privacy and confidential commercial information.10 In addition, synopses of clinical study reports for clinical trials in patients submitted to the United States Food and Drug Administration, European Medicines Agency, or national authorities of European Union member states will be made publicly available on the approval of a new medicine or new indication. Pharmaceutical Research and Manufacturers of America and European Federation of Pharmaceutical Industries and Associations set a date of January 1, 2014, by which these commitments would be implemented.It is now an appropriate time to review what these companies have announced and the current mechanisms for data sharing. Industry is developing new models for sharing and setting the pace for others involved in the clinical research enterprise, including public and nonprofit trial funders. Tables 1 and 2 represent a summary of the current data-sharing policies of the top 12 pharmaceutical companies, based on market capitalization.11 This information was obtained from the companies' public Web sites and organized according to key domains. The data-sharing models continue to evolve in concert with ongoing discussion about the role of funding, the use of trusted intermediaries, the measures needed to protect privacy, and the approaches that are most likely to promote the responsible conduct of research.Table 1. Top 1 to 6 Pharmaceutical Companies, Ranked by 2013 Market Capitalization11Data-Sharing ParametersPhRMA EFPIA Guidelines10Janssen PharmaceuticalsPfizerNovartisRocheSanofiMerckClinical trial data available for sharing• CSR synopses should be available• Requests for full CSRs, IPD, and study-level data should be considered• Data from interventional trials for products and indications approved in both the EU and United States (older studies may be difficult to access)9• Global trials that ended after September 2007• Trials for which results are posted on ClinicalTrials.gov12• January 2014 to present• Phase II–III trials for new medicines or indications approved by the EU and US regulatory agencies13• January 1999 to present• Trials from terminated programs• Phase II–III trials, and some phase IV trials, for new medicines that have been approved by the EU and US regulatory agencies14,15• January 2014 to present• Trials approved by EU and US regulatory agencies and accepted for publication16• September 2007 to present• Trials approved by EU and US regulatory agencies and accepted for publication• Trials for which results are posted on ClinicalTrials.gov17Data not available for sharing• Trials with possibility of reidentification (rare diseases, etc)• ICF restrictions• Legal restrictions to sharing, such as partnering agreements• PhRMA EFPIA guidelines• Undue resources required to share (ie, older studies)9• PhRMA EFPIA guidelines18• Trials for which results are not posted on ClinicalTrials.gov12• PhRMA EFPIA guidelines• Studies supporting device registration• Phase I studies• Some phase IV studies13• PhRMA EFPIA guidelines14,15• Substantial practical constraints (eg, large databases)• Undue resources required to share (eg, older studies)15• PhRMA EFPIA guidelines16• PhRMA EFPIA guidelines• Trials for which results are not posted on ClinicalTrials.gov• Phase I-Healthy participant trials• Consumer healthcare studies• Substantial practical constraints (eg, large databases)17Types of data provided• Clinical trial materials for medicines and indications approved in United States and EU:• Anonymized IPD• Study-level clinical trial data• Protocols• Deidentified IPD• Redacted full CSRs• CSR summaries (publicly available)**• Protocols and supporting documents9• Anonymized IPD• CSR summaries (publicly available)18,19• Anonymized IPD• Redacted full CSRs• CSR summaries (publicly available)• Protocols and supporting documents13,20• Anonymized IPD• Redacted full CSRs• CSR summaries (publicly available)• Protocols and supporting documents14,15• Anonymized IPD• Redacted full CSRs• Protocols and supporting documents16• Anonymized IPD• Redacted full CSRs17Availability of CRFsNA• Blank CRF templates available9• Not stated• Blank CRF templates available13• Blank CRF templates available15• Blank CRF templates available16• Not statedData access feeNA• None9• None stated• None stated• None stated• None stated• None statedData application requirements of note• Research proposal including hypothesis, data requested, and research rationale• Plans for analysis, publication and posting• Research team qualifications, experience, and any potential COIs• Potential for competitive use of the data• Funding sources• Researcher must not transfer shared data to individuals not listed on the proposal• Data must not be used for purposes not described in the proposal• No attempt should be made to reidentify participants• PhRMA EFPIA guidelines• Scientific purpose is clearly described• Data requested will be used to create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health• Proposed research can be reasonably addressed using the requested data • Proposals submitted for non-scientific purposes, such as in pursuit of litigation or for commercial interests, will not be approved9• PhRMA EFPIA guidelines• Rigorous statistical analysis plan• IRB documentation• CVs of all researchers18• PhRMA EFPIA guidelines21• PhRMA EFPIA guidelines14,15• Biostatistician on research team• Detailed statistical analysis plan14• Requestor seeks publication of their research results14,15• Research Proposal is related to the medicine or disease researched in the selected studies• The names of 3 independent experts whom the independent review panel could consult regarding scientific merit, if requested14• PhRMA EFPIA guidelines22• Any use of the data by a third party must address a scientific question in the same disease as the original trial unless the informed consent expressly allows broader use16• PhRMA EFPIA guidelines• CVs of all researchers• Biostatistician on research team17Data request review process• Review process should include external scientists and healthcare professionals, with identity and existing relationships publicly posted• All data requests go directly to the YODA Project†, which reviews for scientific merit and makes final decision• Janssen performs a due diligence assessment to determine its ability to make the data available to be shared externally• Reviewers are publicly named9• Internal Pfizer review committee reviews requests for data first• Independent Review Panel reviews requests that Pfizer declines and makes final decision• Reviewers are publicly named• Three of the 4 panel members are on the Pfizer external Bioethics Advisory Panel18• Research proposals are checked by Novartis to make sure the information is complete and that they meet the requirements of this initiative and the sponsor's requirements for informed consent• They are then sent to an Independent Review Panel* that performs a high-level scientific review including qualifications of researchers and biostatistician and the scientific rationale and relevance of the proposed research to medical science or patient care• Researcher may be asked for names of 3 independent experts to perform an additional review• There is no appeal process21• Reviewers are publicly named23• Roche reviews requests for data first to determine status of the requested data14• Independent Review Panel* reviews for scientific merit and value, among other considerations14,24• Independent Review Panel* reviews for scientific merit, feasibility, and advancement of medical knowledge and public health22• Reviewers are publicly named22,23• An internal Merck review committee reviews for feasibility, scientific validity of the request and the qualifications of the requesters• If there are questions regarding scientific validity, the request is forwarded to a non-Merck External Scientific Review Board (ESRB) for further review• A recommendation from the ESRB is then communicated to a Merck Steering Committee, which is composed of the research heads of clinical, regulatory, and biostatistics• Final decision is made by Merck Steering Committee17• ESRB members are publicly named25COI indicates conflict of interest; CRF, case report form; CSR, clinical study report; CV, curriculum vitae; EFPIA, European Federation of Pharmaceutical Industries and Associations; EU, European Union; ICF, informed consent form; IPD, individual patient-level data; IRB, institutional review board; PhRMA, Pharmaceutical Research and Manufacturers of America; and YODA, Yale University Open Data Access.*Independent Review Panel is shared by ClinicalStudyDataRequest.com companies.**Process for making CSR summaries publicly available is being developed.†The YODA Project data request website is being developed. Those wishing to submit a request for Janssen data can visit http://www.clinicaltrialstudytransparency.com in the interim.Table 2. Top 7 to 12 Pharmaceutical Companies, Ranked by 2013 Market Capitalization11Data-Sharing ParametersPhRMA EFPIA Guidelines10GlaxoSmithKlineBayerBristol-Myers SquibbAbbVieEli LillyAstraZeneca31Clinical trial data available for sharing• CSR synopses should be available• Requests for full CSRs, IPD, and study-level data should be considered• December 2000 to present• All global interventional clinical studies26• January 2014 to present• Data on new medicines and indications that have been approved by EU and/or US regulatory agencies without plans for further regulatory review or submissions• CSR summaries are publically available back to 200527• January 2008 to present• Phase I–IV interventional trials for medicines and indications approved in the United States and the EU28• All data for medicines and indications approved in the United States and the EU29• Interventional clinical studies for approved indications of medicines on the market in the United States and EU30• Not statedData not available for sharing• Trials with possibility of reidentification (rare diseases, etc)• ICF restrictions• Legal restrictions to sharing, such as partnering agreements• PhRMA EFPIA guidelines• Substantial practical constraints (eg, large databases)• Undue resources required to share (eg, older studies)• Studies of consumer healthcare products26• PhRMA EFPIA guidelines• Substantial practical constraints (eg, large databases)27• PhRMA EFPIA guidelines• Studies completed before 200828• None stated• PhRMA EFPIA guidelines32• Not statedTypes of data provided• Clinical trial materials for medicines and indications approved in United States and EU:• Anonymized IPD• Study-level clinical trial data• Protocols• Anonymized IPD• Redacted full CSRs• Protocols and supporting documents26• Anonymized IPD• Redacted full CSRs• Protocols and supporting documents27• IPD• Study-level data• Redacted full CSRs• Protocols28• Anonymized IPD• Study-level data• Protocols29• Anonymized IPD32• IPD• ProtocolsAvailability of CRFsNA• Blank CRF templates available26• Blank CRF templates available27• Not stated• Not stated• Not stated• Not statedData access feeNA• None stated• None stated• None stated• None stated• None stated• None statedData application requirements of note• Research proposal including hypothesis, data requested, and research rationale• Plans for analysis, publication, and posting• Research team qualifications, experience, and any potential COIs• Potential for competitive use of the data• Funding sources• Researcher must not transfer shared data to individuals not listed on the proposal• Data must not be used for purposes not described in the proposal• No attempt should be made to reidentify participants• PhRMA EFPIA guidelines• Biostatistician on research team• Researchers asked to certify IRB review in the DUA21• PhRMA EFPIA guidelines• Biostatistician on research team• Researchers asked to certify IRB review in the DUA21• PhRMA EFPIA guidelines• CVs of all research team members28• PhRMA EFPIA guidelines• Detailed statistical analysis plan• Biostatistician on research team• CV of lead researcher29• Researchers asked to certify IRB review in the DUA30• PhRMA EFPIA guidelines• Biostatistician on research team32• Not statedData request review process• Review process should include external scientists and healthcare professionals, with identity and existing relationships publicly posted• Research proposals are checked by GSK to make sure the information is complete and that they meet the requirements of this initiative and the sponsor's requirements for informed consent• They are then sent to an Independent Review Panel* that performs a high-level scientific review, including qualifications of researchers and biostatisticians and the scientific rationale and relevance of the proposed research to medical science or patient care• Researcher may be asked for names of 3 independent experts to perform an additional review• There is no appeal process21• Reviewers are publicly named23• Research proposals are checked by Bayer to determine technical feasibility, make sure the information is complete, and that they meet the requirements of this initiative and the sponsor's requirements for informed consent• They are then sent to an Independent Review Panel* that performs a high-level scientific review, including qualifications of researchers and biostatisticians and the scientific rationale and relevance of the proposed research to medical science or patient care• Researcher may be asked for names of 3 independent experts to perform an additional review• There is no appeal process21• Reviewers are publicly named21• All requests reviewed internally by a qualified panel of Bristol-Myers Squibb experts and then passed to an Independent Review Committee (IRC) of external experts for review and final decision• Data requests evaluated based on the scientific rationale and methodology of the proposed research28• All requests managed by AbbVie, who may either grant or deny a request after reviewing the requestor's proposal• AbbVie will ensure that the proposal has clearly defined research questions, scientific merit, and that the researcher-directed analyses follow the research proposal• Access to Clinical Research Information Board (ATCRIB) reviews requests that AbbVie declines and makes a final decision• ATCRIB will be independent and publicly named30• Researcher first completes a request for availability of clinical study data form• Lilly reviews the request and determines whether the data are available for deidentification and sharing• If the data are available, a research proposal form is sent to the researcher and reviewed by Lilly once submitted• Data requests evaluated based on a scientific rationale that is relevant to medical science or patient care and a high-level review of the proposed research plan to meet the scientific objectives32• AstraZeneca considers requests for patient level data from other parties on a case-by-case basis, following consistent criteria to establish if and how the information provided will be used for valid scientific purposes and to benefit patientsCOI indicates conflict of interest; CRF, case report form; CSR, clinical study report; CV, curriculum vitae; DUA, data use agreement; EFPIA, European Federation of Pharmaceutical Industries and Associations; EU, European Union; GSK, GlaxoSmithKline; ICF, informed consent form; IPD, individual patient-level data; IRB, institutional review board; and PhRMA, Pharmaceutical Research and Manufacturers of America.*Independent Review Panel is shared by ClinicalStudyDataRequest.com companies.It is clear that a sea change in concept and action has occurred, at least in industry. Scientists now have access to data that required billions of dollars to produce. Furthermore, the actions of these pharmaceutical companies are honoring the good faith of subjects who participated in scientific research, providing more opportunity to learn from the data that were generated while taking measures to ensure that the privacy of trial subjects is fully respected.There is much still to do, and the challenges are considerable. Data sharing allows for replication of results and extension of knowledge from investments in creating data resources. It promotes the engagement of scientists in public dialogue about clinical studies and their interpretation. It is an impediment to fraud and has the potential to expose poorly conducted studies, although it also introduces the potential for false claims and increased litigation resulting from the work of inadequately skilled scientists. In addition, there are the ever-present concerns surrounding violations of subject privacy or abrogation of the spirit of their informed consent. Other issues related to costs and who will bear them in the long-term are yet to be resolved. The goal of data release ought to be to enhance the likelihood of the benefits and minimize the possibility of the harms—and for the approach to be sustainable and the conditions favorable for attracting scientists to make use of the data. Such issues are being widely discussed in forums such as a focused workgroup of the Institute of Medicine that includes a broad range of stakeholders.33Academia, outside of the basic sciences, remains far from a consensus on data sharing. Findings from many studies are never published or are published after long delays, including a high proportion of those funded by the National Institutes of Health.34,35 Trial results often go unreported on ClinicalTrials.gov.36 Although there are obstacles to be overcome in the academic environment, including funding, academic credit, and privacy issues, the current situation is untenable. It is time for academia to meet the standards that are being established by industry.For now, scientists worldwide are encouraged to use these data that are being disseminated by industry–data that have the potential to be an unprecedented resource. These data are being made available to facilitate the development and testing of new hypotheses, to confirm or refute existing beliefs, and to advance knowledge in an effort to improve patient outcomes and public health. The success of data-sharing initiatives should be measured not by how many databases are made available but by how much useful knowledge is efficiently produced through their use and whether health and health care are improved as a result. The summary of policies presented here demonstrates that leaders in industry have overcome significant challenges to take the first critical steps toward changing the culture of science.Sources of FundingThis work was supported by grant U01 HL105270-04 (Center for Cardiovascular Outcomes Research at Yale University) from the National Heart, Lung, and Blood Institute. Dr. Ross is supported by grants K08 AG032886 and K08 AG038336 from the National Institute on Aging and by the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program.DisclosuresH.M. Krumholz, C.P. Gross, K.L. Blount, J.D. Ritchie, B. Hodshon, R. Lehman, and J.S. Ross disclose that they are recipients of research grants from Medtronic and Johnson & Johnson, through Yale University, to develop methods of clinical trial data sharing. H.M. Krumholz discloses that he chairs a cardiac scientific advisory board for UnitedHealth, and J.S. Ross discloses that he is a member of a scientific advisory board for FAIR Health.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Harlan M. Krumholz, MD, SM, Yale University School of Medicine, 1 Church St, Suite 200, New Haven, CT 06510. E-mail [email protected]References1. AllTrials. All trials registered/All results reported.http://www.alltrials.net/. Accessed May 21, 2014.Google Scholar2. Gøtzsche PC. Strengthening and opening up health research by sharing our raw data.Circ Cardiovasc Qual Outcomes. 2012; 5:236–237.LinkGoogle Scholar3. Krumholz HM. 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