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Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk (2015)

Chapter: Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization

« Previous: Appendix C: Legal Discussion of Risks to Industry Sponsors
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Appendix D

Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization

The following tables were reproduced from [Circulation: Cardiovascular Quality and Outcomes, Harlan M. Krumholz, Cary P. Gross, Katrina L. Blount, Jessica D. Ritchie, Beth Hodshon, Richard Lehman, and Joseph S. Ross, 7, 499-504, 2014] with permission from BMJ Publishing Group Ltd.

Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

TABLE D-1 Top 1 to 6 Pharmaceutical Companies, Ranked by 2013 Market Capitalization

Data-Sharing Parameters PhRMA EFPIA Guidelines Janssen Pharmaceuticals Pfizer
Clinical 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)
  • Global trials that ended after September 2007
  • Trials for which results are posted on ClinicalTrials. gov
 
Data not available for sharing
  • Trials with possibility of re-identification (rare diseases, etc)
  • ICF restrictions
  • Legal restrictions to sharing, such as partnering agreements
  • PhRMA EFPIA guidelines
  • Undue resources required to share (ie, older studies)
 
Types 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 documents
  • Anonymized IPD
  • CSR summaries (publicly available)
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Novartis Roche Sanofi Merck
  • January 2014 to present
  • Phase II–III trials for new medicines or indications approved by the EU and US regulatory agencies
  • 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 agencies
  • January 2014 to present
  • Trials approved by EU and US regulatory agencies and accepted for publication
  • September 2007 to present
  • Trials approved by EU and US regulatory agencies and accepted for publication
  • Trials for which results are posted on ClinicalTrials.gov
 
  • PhRMA EFPIA guidelines
  • Studies supporting device registration
  • Phase I studies
  • Some phase IV studies
  • PhRMA EFPIA guidelines
  • Substantial practical constraints (eg, large databases) • Undue resources required to share (eg, older studies)
  • PhRMA EFPIA guidelines
  • 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)
 
  • Anonymized IPD
  • Redacted full CSRs
  • CSR summaries (publicly available)
  • Protocols and supporting documents
  • Anonymized IPD
  • Redacted full CSRs
  • CSR summaries (publicly available)
  • Protocols and supporting documents
  • Anonymized IPD
  • Redacted full CSRs
  • Protocols and supporting documents
  • Anonymized IPD
  • Redacted full CSRs
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Data-Sharing Parameters PhRMA EFPIA Guidelines Janssen Pharmaceuticals Pfizer
Availability of CRFs NA
  • Blank CRF templates available
  • Not stated
 
Data access fee NA
  • None
  • None stated
 
Data 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 approved
  • PhRMA EFPIA guidelines
  • Rigorous statistical analysis plan
  • IRB documentation
  • CVs of all researchers
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Novartis Roche Sanofi Merck
  • Blank CRF templates available
  • Blank CRF templates available
  • Blank CRF templates available
  • Not stated
 
  • None stated
  • None stated
  • None stated
  • None stated
 
  • PhRMA EFPIA guidelines
  • PhRMA EFPIA guidelines
  • Biostatistician on research team
  • Detailed statistical analysis plan
  • Requestor seeks publication of their research results
  • 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 requested
  • PhRMA EFPIA guidelines
  • 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 use
  • PhRMA EFPIA guidelines
  • CVs of all researchers
  • Biostatistician on research team
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Data-Sharing Parameters PhRMA EFPIA Guidelines Janssen Pharmaceuticals Pfizer
Data 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 named
  • 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 Panel
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Novartis Roche Sanofi Merck
  • 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 process
  • Reviewers are publicly named
  • Roche reviews requests for data first to determine status of the requested data
  • Independent Review Panel* reviews for scientific merit and value, among other considerations
  • Independent Review Panel* reviews for scientific merit, feasibility, and advancement of medical knowledge and public health
  • Reviewers are publicly named
  • 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 Committee
  • ESRB members are publicly named 
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

NOTE: COI 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.

TABLE D-2 Top 7 to 12 Pharmaceutical Companies, Ranked by 2013 Market Capitalization

Data-Sharing Parameters PhRMA EFPIA Guidelines GlaxoSmithKline Bayer
Clinical 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 studies
  • 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 publicly available back to 2005
 
Data not available for sharing
  • Trials with possibility of re-identification (rare diseases, etc)
  • ICF restrictions
  • Legal restrictions to sharing, such as partnering agreements
  • PhRMA EFPIA guidelines
  • Substantial practical constraints (e.g., large databases) • Undue resources required to share (e.g., older studies)
  • Studies of consumer healthcare products
  • PhRMA EFPIA guidelines
  • Substantial practical constraints (e.g., large databases)
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

* 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.

Bristol-Myers Squibb AbbVie Eli Lilly AstraZeneca
  • January 2008 to present
  • Phase I–IV interventional trials for medicines and indications approved in the United States and the EU
  • All data for medicines and indications approved in the United States and the EU
  • Interventional clinical studies for approved indications of medicines on the market in the United States and EU
  • Not stated
 
  • PhRMA EFPIA guidelines
  • Studies completed before 2008
  • None stated
  • PhRMA EFPIA guidelines
  • Not stated
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Data-Sharing Parameters PhRMA EFPIA Guidelines GlaxoSmithKline Bayer
Types 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 documents
  • Anonymized IPD
  • Redacted full CSRs
  • Protocols and supporting documents
 
Availability of CRFs NA
  • Blank CRF templates available
  • Blank CRF templates available
 
Data access fee NA
  • None stated
  • None stated
 
Data 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 re-identify participants
  • PhRMA EFPIA guidelines
  • Biostatistician on research team
  • Researchers asked to certify IRB review in the DUA
  • PhRMA EFPIA guidelines
  • Biostatistician on research team
  • Researchers asked to certify IRB review in the DUA
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Bristol-Myers Squibb AbbVie Eli Lilly AstraZeneca
  • IPD
  • Study-level data
  • Redacted full CSRs
  • Protocols
  • Anonymized IPD
  • Study-level data
  • Protocols
  • Anonymized IPD
  • IPD
  • Protocols
 
  • Not stated
  • Not stated
  • Not stated
  • Not stated
 
  • None stated
  • None stated
  • None stated
  • None stated
 
  • PhRMA EFPIA guidelines
  • CVs of all research team members
  • PhRMA EFPIA guidelines
  • Detailed statistical analysis plan
  • Biostatistician on research team
  • CV of lead researcher
  • Researchers asked to certify IRB review in the DUA
  • PhRMA EFPIA guidelines
  • Biostatistician on research team
  • Not stated
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Data-Sharing Parameters PhRMA EFPIA Guidelines GlaxoSmithKline Bayer
Data 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 process
  • Reviewers are publicly named
  • 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 process
  • Reviewers are publicly named
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
Bristol-Myers Squibb AbbVie Eli Lilly AstraZeneca
  • 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 research
  • 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 named
  • 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 objectives
  • 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 patients
Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

NOTE: COI 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.

Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health.

Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs.

Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

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