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1 Introduction
Pages 1-8

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From page 1...
... The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing.
From page 2...
... c The public workshop will feature invited presentations and discussions to: • Consider the value and the potential risks and costs of sharing clinical trial data for key stakeholders, including clinical trialists, sponsors, pri mary and secondary researchers,a and patients; • Review the current landscape of clinical trial data sharing and reuse across public and private sectors (e.g., policies, platforms, collabora tions, data-sharing culture, published research output) ; • Examine use cases and trends from across public and private sectors when it comes to success, failure, lessons learned, and value; • Consider the perspectives and expectations of primary and secondary researchers, clinical trial participants, patient organizations, research sponsors (pharmaceutical companies and nonprofit organizations)
From page 3...
... The fourth recommendation called for an ongoing, multi-stakeholder process to address the structural and logistical elements of data sharing. PROGRESS MADE IN CLINICAL TRIAL DATA SHARING SINCE THE 2015 INSTITUTE OF MEDICINE CONSENSUS STUDY REPORT To reflect on progress made in clinical trial data sharing since the release of the 2015 IOM consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, Drazen said that data collected during randomized controlled clinical trials were originally considered to
From page 4...
... As data science and technology have evolved to better enable researchers to analyze large volumes of data, discussions regarding data ownership and the need for data sharing have continued to advance. Today, Drazen said, the focus is on finding ways to share clinical trial data for the benefit of key stakeholder groups: the clinical trial participants who put themselves at risk, the skilled clinical trialists who gather the high-quality data, and the data scientists who mine and analyze the data for new insights.
From page 5...
... For example, sharing data from a large-scale, multi-center, pivotal clinical trial that was designed to impact clinical practice could be of high value. There are also opportunity costs that should be recognized and quantified, Lo concluded (e.g., external parties may beat investigators to conducting planned secondary analyses as a result of trial data being simultaneously released with publication, and may be a disincentive in clinical research)
From page 6...
... Most clinical trials appear to be registered, she said, although about one-third of these trials were registered late (more than 3 months after the start of the trial)
From page 7...
... , the first three workshop panels considered the current landscape for clinical trial data sharing and reuse. Panelists shared their perspectives on current data-sharing policies in practice (Chapter 2)
From page 8...
... . The next three panels considered some of the key challenges to clinical trial data sharing and reuse.


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