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Appendix D: Clinical Trial Data Sharing Policies: Top 1-12 Pharmaceutical Companies Ranked by 2013 Market Capitalization
Pages 267-280

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From page 267...
... 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
From page 268...
... restrictions to sharing, such as partnering agreements Types of data • Clinical trial • Deidentified • Anonymized IPD provided materials for IPD • CSR summaries medicines and • Redacted full (publicly available) indications CSRs approved in • CSR summaries United States (publicly and EU: available)
From page 269...
... • Anonymized • Anonymized • Anonymized • Anonymized IPD IPD IPD IPD • Redacted full CSRs • Redacted full • Redacted full • Redacted full CSRs CSRs CSRs • CSR summaries • CSR summaries • Protocols and (publicly (publicly supporting available) available)
From page 270...
... 270 SHARING CLINICAL TRIAL DATA TABLE D-1 Continued Data-Sharing PhRMA EFPIA Janssen Parameters Guidelines Pharmaceuticals Pfizer Availability of NA • Blank CRF • Not stated CRFs templates available Data access fee NA • None • None stated Data application • Research • PhRMA EFPIA • PhRMA EFPIA requirements of proposal guidelines guidelines note including • Scientific • Rigorous statistical hypothesis, purpose analysis plan data requested, is clearly • IRB documentation and research described • CVs of all rationale • Data requested researchers • Plans for will be used analysis, to create or publication and materially posting enhance • Research team generalizable qualifications, scientific and/ experience, and or medical any potential knowledge to COIs inform science • Potential for and public competitive use health of the data • Proposed • Funding sources research can • Researcher must be reasonably not transfer addressed using shared data to the requested individuals not data listed on the • Proposals proposal submitted for • Data must not non-scientific be used for purposes, such purposes not as in pursuit described in the of litigation or proposal for commercial • No attempt interests, will should be made not be approved to reidentify participants
From page 271...
... APPENDIX D 271 Novartis Roche Sanofi Merck • Blank CRF • Blank CRF • Blank CRF • Not stated templates templates templates available available available • None stated • None stated • None stated • None stated • PhRMA EFPIA • PhRMA EFPIA • PhRMA EFPIA • PhRMA EFPIA guidelines guidelines guidelines guidelines • Biostatistician • Any use of • CVs of all on research the data by researchers team a third party • Biostatistician on • Detailed must address research team statistical a scientific analysis plan question in the • Requestor seeks same disease publication of as the original their research trial unless results the informed • Research consent Proposal is expressly related to allows broader the medicine use 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 continued
From page 272...
... 272 SHARING CLINICAL TRIAL DATA TABLE D-1 Continued Data-Sharing PhRMA EFPIA Janssen Parameters Guidelines Pharmaceuticals Pfizer Data request • Review process • All data • Internal Pfizer review process should include requests go review committee external directly to the reviews requests scientists and YODA Project†, for data first healthcare which reviews • Independent professionals, for scientific Review Panel with identity merit and reviews requests and existing makes final that Pfizer declines relationships decision and makes final publicly posted • Janssen decision performs a • Reviewers are due diligence publicly named assessment • Three of the 4 to determine panel members its ability to are on the Pfizer make the data external Bioethics available to Advisory Panel be shared externally • Reviewers are publicly named
From page 273...
... • A recommendation that performs from the a high-level ESRB is then scientific review communicated to including a Merck Steering qualifications of Committee, which researchers and is composed of the biostatistician research heads of and the clinical, regulatory, scientific and biostatistics rationale and • Final decision relevance of is made by the proposed Merck Steering research to Committee medical science • ESRB members are or patient care publicly named • Researcher may be asked for names of 3 independent experts to perform an additional review • There is no appeal process • Reviewers are publicly named continued
From page 274...
... constraints (e.g., constraints (e.g., • ICF restrictions large databases) large databases)
From page 275...
... Bristol-Myers Squibb AbbVie Eli Lilly AstraZeneca • January 2008 to • All data for • Interventional • Not stated present medicines and clinical studies • Phase I–IV indications for approved interventional approved in the indications trials for United States of medicines medicines and and the EU on the market indications in the United approved in the States and EU United States and the EU • PhRMA EFPIA • None stated • PhRMA EFPIA • Not stated guidelines guidelines • Studies completed before 2008 continued
From page 276...
... 276 SHARING CLINICAL TRIAL DATA TABLE D-2 Continued Data-Sharing PhRMA EFPIA Parameters Guidelines GlaxoSmithKline Bayer Types of data • Clinical trial • Anonymized IPD • Anonymized IPD provided materials for • Redacted full • Redacted full medicines and CSRs CSRs indications • Protocols and • Protocols and approved in supporting supporting United States and documents documents EU: --  nonymized A IPD --  tudy-level S clinical trial data --  rotocols P Availability of NA • Blank CRF • Blank CRF CRFs templates templates available available Data access fee NA • None stated • None stated Data application • Research proposal • PhRMA EFPIA • PhRMA EFPIA requirements of including guidelines guidelines note hypothesis, data • Biostatistician on • Biostatistician on requested, and research team research team research rationale • Researchers • Researchers asked • Plans for analysis, asked to certify to certify IRB publication, and IRB review in the review in the posting DUA DUA • 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
From page 277...
... APPENDIX D 277 Bristol-Myers Squibb AbbVie Eli Lilly AstraZeneca • IPD • Anonymized • Anonymized • IPD • Study-level IPD IPD • Protocols data • Study-level • Redacted full data CSRs • Protocols • Protocols • Not stated • Not stated • Not stated • Not stated • None stated • None stated • None stated • None stated • PhRMA EFPIA • PhRMA EFPIA • PhRMA EFPIA • Not stated guidelines guidelines guidelines • CVs of all • Detailed • Biostatistician research team statistical on research members analysis plan team • Biostatistician on research team • CV of lead researcher • Researchers asked to certify IRB review in the DUA continued
From page 278...
... including that performs qualifications of a high-level researchers and scientific review, biostatisticians including and the scientific qualifications of rationale and researchers and relevance of biostatisticians the proposed and the scientific research to rationale and medical science relevance of the or patient care proposed research • Researcher to medical science may be asked or patient care for names of • Researcher 3 independent may be asked experts to for names of perform an 3 independent additional review experts to • There is no perform an appeal process additional review • Reviewers are • There is no publicly named appeal process • Reviewers are publicly named
From page 279...
... rationale that reviews is relevant to requests medical science that AbbVie or patient care declines and and a high makes a final level review of decision the proposed • ATCRIB will research plan be independent to meet the and publicly scientific named objectives continued
From page 280...
... * Independent Review Panel is shared by ClinicalStudyDataRequest.com companies.


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