Policy to Guide External Investigator Access to Clinical Trial Data
The Yale University Open Data Access (YODA) Project is an effort by a group of academically-based clinical researchers to promote and facilitate the sharing of clinical trial data. This set of policies, which represents a refinement of policies that guided access to data made available by Medtronic, Inc., is intended not only to cover the YODA Project’s partnership with Johnson & Johnson, but also to set standards that will be relevant to future efforts with similar aspirations. Importantly, the YODA Project has the final decision-making rights regarding these policies – and, by extension, the granting or denial of data requests, as per the contractual agreements between the YODA Project and its partners.
By serving this role, the YODA Project’s goal is to enhance data availability and transparency in support of strong scientific research which aims to advance scientific and medical knowledge with the ultimate goal of improving public health and healthcare delivery. This document outlines the YODA Project’s policy to guide its decision-making related to granting access to these data. The YODA Project seeks to continually improve these policies and, accordingly, may modify the policy in the future.
What is the YODA Project?
The YODA Project is an effort by a group of academically-based clinical researchers to facilitate access to participant-level clinical research data and/or comprehensive reports of clinical research, such as full Clinical Study Reports (CSRs), a level of detail not customarily found in journal publications, with the aim of promoting scientific research that may advance science or lead to improvements in individual and public health and healthcare delivery. The YODA Project is guided by the following core principles, which reflect the overall mission of the project to promote open science by:
• Promoting the sharing of clinical research data to advance science and improve public health and healthcare
• Promoting the responsible conduct of research
• Ensuring good stewardship of clinical research data
• Protecting the rights of research participants
This data release policy applies to all requests received by the YODA Project for access to clinical trial data held by a third party with whom the YODA Project has an agreement to serve in a decision-making role regarding the granting or denial of these requests. This policy addresses the research proposal requirements, data receipt, data analysis, and dissemination of results. Specifically, the policy guides the procedures that will be used to make completed clinical trial data (including both CSRs and participant-level data) available to external investigators for independent scientific examination. This policy does not apply to requests for research partnerships or other types of data, such as biological, pharmacological, radiographic, or genetic data, which are beyond the scope of the YODA Project.
This policy was informed by the following:
• The YODA Project’s prior experience with sharing Medtronic’s participant-level clinical trial data for recombinant human bone morphogenetic protein-2 (rhBMP-2);
• Recommendations from the YODA Project Steering Committee, an independent group of leaders in the fields of clinical research and biomedical ethics convened by the YODA Project to provide guidance;
• Recommendations from other experts, stakeholders, and industry partners; and
• The YODA Project’s review of the literature and policies from other bodies engaged in clinical trial data sharing.
The YODA Project is committed to facilitating external access to clinical trial data being made available by third party Data Holders to promote research that informs science and public health. The project does not support requests to use data for non-scientific purposes, such as in pursuit of litigation or for commercial interests.
The YODA Project will require that requestors provide basic information about the Principal Investigator, Key Personnel, and the project Research Proposal, including a scientific abstract and research methods. Registration information will be used by the YODA Project to track use of the data, promote the responsible conduct of research, and to publicly post information about who has obtained access to the data and for what scientific purpose.
The YODA Project will review proposals to ensure that the proposal has scientific merit, in that 1) the scientific purpose is clearly described; 2) the data requested will be used to create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health; and 3) the proposed research can be reasonably addressed using the requested data. Scientific review by peer experts and/or members of the YODA Project Steering Committee may be solicited if the YODA Project is unable to verify the scientific merit of the proposal.
The YODA Project will request a Due Diligence Assessment by the Data Holder if the requested data are not currently available in a secure data sharing platform in order to determine its ability to make the data available to be shared externally, including estimation of the resources that would be required. Requestors may similarly request such an Assessment for data that are not yet available prior to preparing a full proposal. Requests that include independent funding will be considered, but are neither expected nor required.
The YODA Project will publicly post all requests and registration information, including the Research Proposal and analysis plan, a summary of the Data Holder Due Diligence Assessment, any scientific reviews from peer experts or the YODA Project Steering Committee, and the YODA Project’s decision to grant or deny data access. If access is denied, a public report detailing the reason(s) will be provided. Public posting is intended to promote transparency of clinical research and public accountability of the YODA Project data release process.
Prior to receiving data access, requestors will be asked to sign a Data Use Agreement (DUA). The DUA explicitly states that access to the data will be used to create or materially enhance generalizable scientific knowledge and that findings derived from analysis will initially be publicly disseminated only through the peer-reviewed biomedical literature or scientific meetings, with the exception of unexpected or serious safety findings (which should be reported to the Data Holder immediately for further evaluation and reporting to appropriate health or regulatory authorities). In addition, the requestors must certify not to use or enable others to use the data for commercial purposes or in pursuit of litigation.
Released data will include all data relevant to the Research Proposal that are available, including collected participant-level data sets (appropriately de-identified as per current regional standards to protect patient privacy), annotated case report forms, data set specifications, protocols with any amendments, reporting and analysis plans, and complete CSRs. Depending on the Data Holder, data will be made available either via a password-protected personalized account on a secure data sharing platform or a secure electronic data transfer system.