Read "Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk" at NAP.edu

Page 267 Cite

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.

Page 268 Cite

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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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)	PhRMA EFPIA guidelines Trials for which results are not posted on ClinicalTrials.gov

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)

Page 269 Cite

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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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

Page 270 Cite

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 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

Page 271 Cite

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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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

Page 272 Cite

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 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

Page 273 Cite

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

Page 274 Cite

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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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)

Page 275 Cite

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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* 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

Page 276 Cite

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

Page 277 Cite

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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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

Page 278 Cite

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 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

Page 279 Cite

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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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

Page 280 Cite

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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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.