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Pages 1-16

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From page 1...
... The challenge is to set clear expectations that clinical trial data should be shared and to agree on how to do so in a responsible manner that mitigates the risks involved. Stakeholders have concerns about data sharing.
From page 2...
... Guiding Principles for Sharing Clinical Trial Data The goal of responsible sharing of clinical trial data should be to increase scientific knowledge that leads to better therapies for patients. The committee formulated the following guiding principles for responsible sharing of clinical trial data: • Maximize the benefits of clinical trials while minimizing the risks of sharing clinical trial data.
From page 3...
... For the purposes of this study, data generator will include industry sponsors, data repositories, and researchers conducting clinical trials. Specifically, the committee will: •  rticulate guiding principles that underpin the responsible sharing of clinical A trial data. •  escribe a selected set of data and data sharing activities, including but not D limited to: − Types of data (e.g., summary, participant)
From page 4...
... The committee envisaged that different approaches to sharing clinical trial data will be developed and urges learning from experience with these approaches. Recommendation 1: Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm, and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties.
From page 5...
... Research Ethics Committees or IRBs should • provide guidance for clinical trialists and templates for informed consent for participants that enable responsible data sharing; • consider data sharing plans when assessing the benefits and risks  of clinical trials; and • adopt protections for participants as recommended by this com mittee and the emerging best practices of clinical trial data sharing initiatives. Investigators and sponsors should • design clinical trials and manage trial data with the expectation that data will be shared; • adopt common data elements in new clinical trial protocols unless there is a compelling scientific reason not to do so; • explain to participants during the informed consent process −  hat data will (and will not)
From page 6...
... Journals should • require authors of both primary and secondary analyses of clinical trial data to − document that they have submitted a data sharing plan at a  site that shares data with and meets the data requirements of the World Health Organization's International Clinical Trials Registry Platform before enrolling participants, and −  ommit to releasing the analytic data set underlying published c analyses, tables, figures, and results no later than the times specified in this report; • require that submitted manuscripts using existing data sets from clinical trials, in whole or in part, cite these data appropriately; and • require that any published secondary analyses provide the data and metadata at the same level as in the original publication. Membership and professional societies should • establish as policy that members should participate in sharing clinical trial data as part of their professional responsibilities; • require as a condition of submitting abstracts to a meeting of the society and manuscripts to the journal of the society that clinical trial data will be shared in accordance with the recommendations in this report; and • collaborate on and promote the development and use of common data elements relevant to their members.
From page 7...
... • Explaining to trial participants what data will be shared during the informed consent process and making their own data available to them following study completion and data analysis help uphold public trust in clinical trials. The committee applied these considerations to clinical trial data for trials initiated after this report only, recognizing that sharing data from legacy trials may present greater risks and burdens and thus needs to be deliberated on a case-by-case basis.
From page 8...
... The committee hopes that the evolution of responsible sharing of clinical trial data will be guided by empirical evidence. At the same time, the committee recognized that there will be justifiable exceptions to its recommendations in light of the wide variation in clinical trials.
From page 9...
... The committee believes that this recommendation will set professional standards and establish expectations that clinical trial data should be shared (see also Figure S-1) : Recommendation 2: Sponsors and investigators should share the various types of clinical trial data no later than the times specified below.
From page 10...
... , full statistical analysis plan (including all amendments and all documentation for additional work processes) , and analytic code.
From page 11...
... They are strongly urged to do so for major and significant clinical trials whose findings will influence decisions about clinical care.
From page 12...
... without compromising the usefulness of data sharing for the generation of additional scientific knowledge. Arrangements for determining access to clinical trial data need to balance several goals: protecting the privacy of research participants, reducing the likelihood of invalid analyses or misuse of the shared data, avoiding undue burdens on secondary users seeking access, avoiding undue harms to investigators and sponsors that share data, and enhancing public trust in the sharing of clinical trial data.
From page 13...
... Finally, the committee concluded that the experience of early adopters of the sharing of clinical trial data will undoubtedly offer lessons and best practices from which others can learn. As sponsors try different approaches to data sharing, collecting empirical data that allow comparison of different approaches will provide crucial information on what does and does not work in various contexts.
From page 14...
... • Learn from experience by collecting data on the outcomes of data sharing policies, procedures, and technical approaches (including the benefits, risks, and costs) , and share information and lessons learned with clinical trial sponsors, the public, and other organiza tions sharing clinical trial data.
From page 15...
... Next the committee identified remaining key challenges to responsible sharing of clinical trial data, which include the following: • Infrastructure challenges -- Currently there are insufficient plat forms to store and manage clinical trial data under a variety of access models. • Technological challenges -- Current data sharing platforms are not consistently discoverable, searchable, and interoperable.
From page 16...
... • The costs of responsible sharing of clinical trial data will decrease in the future if data collection and management are designed to facilitate sharing. The committee concluded that a market analysis of the costs of sharing clinical trial data and an economic analysis of options for funding data sharing would provide an evidence base for developing sustainable and equitable models for responsible sharing of clinical trial data.


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