Table 6.

Data request review process of pharmaceutical companies displaying certification via PhRMA or EFPIA websites which solicit data requests via online data sharing platform [47, 83, 84]

Request point/pharma company	Review process
Clinical Study Data Request affiliatesa [120, 121]	Research Proposals are checked and reviewed in 3 stages: Stage 1: by the Wellcome Trust which is the secretariat for the Independent Review Panel (IRP) Stage 2: by the study Sponsors/Funders Stage 3: by the IRP.
Vivli affiliates [219]b	All data requests proceed through three steps during the data request review. Step 1: Vivli Administrator form check — Ensure all required fields of the data request form are completed. Step 2: Data Contributor Review — Check feasibility of fulfilling request. Step 3: Approving Entity, Scientific Panel, or Independent Review Panel — Reviews based upon the merits of the research proposal
Abbvie [53]	All requests from qualified researchers for access to AbbVie clinical data and information will be managed by Vivli and AbbVie. In cases where we reject a particular request based on scientific merit, the request, along with the record of our denial of the request, shall be forwarded to the Access to Clinical Research Information Board (ATCRIB) for a final decision, according to the ATCRIB charter. The ATCRIB is composed of scientists and/or health care professionals who are not AbbVie employees.
Almirall [108]	All requests will be evaluated independently on a case-by-case.
Amgen [54, 109]	Research proposals will be reviewed by a committee of internal advisors. For clinical trials that are subject to agreements with co-development partners, Amgen will liaise with the applicable partners regarding any data sharing requests. In general, Amgen does not support external research questions that involve access to individual patient level data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. If the outcome of the internal review is to decline the request, a Data Sharing Independent Review Panel will arbitrate and make the final decision.
AstraZeneca [100]	An independent Scientific Review Board to review and approve requests. The Scientific Review Board will review requests that go back as far as 2009 through this process. All other requests for data beyond that will continue to be reviewed by AstraZeneca on a case-by-case basis.
Bial [110]	Each request will be evaluated by an independent Scientific Review Board and will be based on criteria that balance the need for scientific development with the need to protect patient privacy.
Biogen [57, 122]	Biogen reviews all data requests internally based on the criteria set forth in our Clinical Trial Transparency and Data Sharing Policy. Requests that are denied in whole or in part are then sent to an independent external review body, whose decision will be made transparent.
Bristol-Myers Squibb [59, 123]	The request/proposal is currently being reviewed internally by a qualified panel of Bristol-Myers Squibb experts. If the proposal is considered within scope, the request will undergo an additional review by the independent review committee.
Celgene [60, 95]	A group of individuals selected by the Celgene Clinical Trial Data Sharing Steering Committee composed of external experts to provide an unbiased review of research proposals submitted by researchers to ensure that the proposals are robust, scientifically sound with a valid and clearly defined hypothesis and include both an analysis and publication plan.
Chiesi [102]	An appointed Chiesi Evaluation Committee starts the assessment of the research proposal. In case of a negative evaluation, but no direct competition is envisaged, Chiesi forwards the assessment to a Scientific Review Board, composed by qualified researchers who are not Chiesi employees.
EMD Serono [63, 124]	Researchers’ requests will be evaluated initially by an internal committee at EMD Serono, which may decide to approve the request. If the EMD Serono committee denies the request, the request will be escalated to the EMD Serono Scientific Review Board for a second review (de novo). The Board shall include scientists and/or healthcare professionals who are not employees of EMD Serono.
Grunenthal [125]	Requests for access to clinical data will be subject to assessment and approval by a Grünenthal Board and then by an independent Scientific Review Board.
Janssen [126]	During the Review, the YODA Project will evaluate submitted requests and associated registration materials to ensure that all required information has been provided. All requests for data will undergo review upon receipt by the YODA Project. During this review, the YODA Project will evaluate submitted requests and associated registration materials to ensure that all required information has been provided and that the Research Proposal has scientific merit. Requests will undergo External Review if the YODA Project is unable to verify the scientific merit of the Research Proposal.
Leo Pharma [112, 113]	The evaluation of the data request and the decision on access to data is made by the external Patient and Scientific Review Board. The Patient and Scientific Review Board comprise three highly experienced scientists while two seats are allocated to representatives of patient associations. The decision by the Patient and Scientific Review Board is made independently of LEO Pharma.
Lundbeck [114]	An external scientific review board is responsible for assessing and granting requests from qualified scientific and medical researchers. If the scientific review board rejects a request, the scientific review board can advise a resubmission.
Menarini Group [105]	All requests will be reviewed internally by a qualified panel of Menarini Group experts (Scientific Secretariat) and then passed to an Independent Review Committee (IRC) of external experts for further review.
Merck & Co. [73]	Completed applications will be reviewed by MSD with Input as needed from an External Scientific Review Board comprised of non-MSD scientists or physicians.
Novo Nordisk [115, 116]	The Independent Review Board assesses all complete requests and approves or rejects the proposal without any interference from Novo Nordisk.
Orion Pharma [117]	After a marketing authorisation has been granted to our new drug, we allow access to our patient-level data based on a scientific review of the request and the proposal from the external research group consisting of qualified scientific and medical researchers.
Otsuka [118]	Research proposals requesting patient-level data are reviewed by an Independent Review Panel at Western Institutional Review Board Copernicus Group. Research proposals for non-listed studies are examined on a case-by-case basis by Otsuka in consultation with the Independent Review Panel.
Pfizer [66, 97]	An internal Pfizer Review Committee conducts the initial review of in scope requests. Any request approved by Pfizer will not require a secondary review by the Independent Review Panel. Pfizer is piloting the use of an Independent Review Panel during 2014. The Panel will review any proposal declined, or partially approved, by Pfizer. The role of the Panel is to review the application, the rationale for Pfizer’s response, and to make a final decision. The decision of the Panel will be binding.
Purdue Pharma [74]	The Purdue Scientific Review Board (SRB) will adjudicate all requests for Information. The SRB will consist of Purdue employees selected by the Chief Medical Officer (CMO) from relevant departments, such as Research and Development, Medical Affairs, Law, and Ethics & Compliance, and two researchers or external experts who are not employees of Purdue.
Regeneron [106, 127]	The Regeneron Investigator-Initiated Study Program, which is comprised of a cross functional team, will evaluate data sharing requests on a case-by-case basis.	Unclear
Servier [107]	Servier will conduct the initial review, including scientific qualification of the researcher, the robustness and scientific merit of the research proposal, the ability of the requested data to answer the research question, and the technical feasibility. If Servier partially approves or declines the request, we send our decision to the IRB for review. The decision made by the IRB is final and binding for Servier.
Shire [68]	Once Shire assesses the validity of the researcher’s data request and determines appropriate consent(s) exists for requested product(s) and indication(s), an internal team made of subject matter experts will review the eligibility of the proposed research against the criteria below and render a decision. In cases where the validity of the researcher or proposed request is in question, Shire will defer the request to an external Independent Review Panel for a final, objective opinion.
Vifor pharma [119]	Unable to locate.

^aIndustry affiliates include Astellas, Bayer, Chugai, Eisai, GlaxoSmithKline, Novartis, Roche, Sanofi, Shionogi, Sumitomo Dainippon, Takeda, UCB, and Viiv healthcare. Non-industry affiliates include Bill and Melinda Gates Foundation, Cancer Research UK, Medical Research Council, and Wellcome Trust

^bIndustry affiliates include Abbvie, Biogen, Boehringer Ingelheim, Celgene, Daiichi-Sankyo, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer, Takeda, Tempus, UCB. Non-industry affiliates include BioLINCC, Critical Path Institute, Cure Duchenne, Doris Duke Foundation, Duke University, Harvard University, ImmPort, Johns Hopkins University, Project Data Sphere, The Leona M. and Harry B. Helmsley Charitable Trust and University of California San Francisco