Sharing Clinical Trial Data Maximizing Benefits, Minimizing Risk (2015) / Chapter Skim
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2 Guiding Principles for Sharing Clinical Trial Data
2 Guiding Principles for Sharing Clinical Trial Data
Pages 31-46
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From page 31... ...
Overview of Key Potential Benefits and Risks Potential Benefits of Data Sharing Sharing of clinical trial data has great potential to accelerate scientific progress and ultimately improve public health by generating better evidence on the safety and effectiveness of therapies for patients. There have been some notable examples of how secondary analyses of shared data have benefited the public, for example, by showing that widely used interventions are ineffective or unsafe (Chan et al., 2014; Doshi et al., 2012; Kaiser et al., 2003; Nissen and Wolski, 2007)
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From page 32... ...
Moreover, sharing clinical trial data could potentially lead to enhanced efficiency and safety of the clinical research process by, for example, reducing unnecessary duplication of effort and the costs of future studies, reducing exposure of participants in future trials to avoidable harms identified through the data sharing, and providing a deeper knowledge base for regulatory decisions (Califf, 2013; Doshi et al., 2013; Eichler et al., 2012; Goldacre, 2013; IOM, 2013; Krumholz et al., 2014; Mello et al., 2013; Ross et al., 2012)
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From page 33... ...
Risks of Data Sharing The potential benefits of sharing clinical trial data and the risks of not sharing need to be weighed against any potential harms from sharing. First, data sharing could put clinical trial participants at increased risk of invasions of privacy or breaches of confidentiality.
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From page 34... ...
If subsequent independent analyses failed to give appropriate recognition to the original investigators, those investigators would not have incentives to conduct clinical trials in the future. Guiding principles The committee offers the following guiding principles as an essential foundation for any approach to sharing clinical trial data.
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The right of patients and the public to the benefits of scientific research is an alternative way of framing the idea that responsible sharing of clinical trial data should be guided by the goal of increasing scientific knowledge that leads to better therapies for patients (Knoppers et al., 2014)
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Respect Through Protections for Research Participants Respect for research participants requires protecting their dignity, integrity, and right to self-determination; this includes, at a minimum, compliance with applicable regulations and ethical standards for the conduct of clinical trials and handling of the resulting data. Respect for research participants has historically been understood to require specific informed consent from participants (including consent for how their data will be used)
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From page 37... ...
For example, additional protections may be needed when participant identifiers cannot be removed from data or must be included in shared data in order to address an important research question. Respect Through Engagement Respect also can be demonstrated and advanced through efforts to engage participants and their representatives in the development of the processes for sharing of clinical trial data, so as to build public trust in the value and importance of data sharing (CTSA, 2011)
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From page 38... ...
. Sharing clinical trial data could enhance public trust by facilitating secondary analyses that could determine whether the final conclusions and summaries of clinical trials are robust, valid inferences from the original evidence, although this must be done in a credible and fair manner (Laine et al., 2007)
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From page 39... ...
Trust in the Data Sharing Process Sharing clinical trial data could carry the risk of undermining public trust in clinical trials under certain circumstances, for example, if multiple analyses were to yield conflicting conclusions (Califf, 2013)
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From page 40... ...
Such mistrust could ultimately lead to seriously flawed clinical care decisions, unwarranted patient concerns about the quality of care, or avoidable patient anxiety. Conduct the Sharing of Clinical Trial Data in a Fair Manner Fairness, broadly articulated, is a core ethical principle that is applicable to the sharing of clinical trial data.
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to share data and to conduct future clinical trials. the Committee's Approach to applying the principles The committee next considered its approach for practical application of the above principles to the issues entailed in sharing clinical trial data.
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If full open transparency of clinical trial data carries on balance more risks than benefits, it does not serve the public good. Rather, the public good is served by policies that seek to attain the benefits of data sharing to advance science and improve clinical care while mitigating its risks to stakeholders.
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From page 43... ...
2013. Clinical trial data sharing and challenges to data sharing: Current and future.
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From page 44... ...
Paper presented at IOM Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting One, October 22-23, Washington, DC. ICH (International Conference on Harmonisation of Technical Requirements for Regis tration of Pharmaceuticals for Human Use)
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2012. The importance of clinical trial data sharing: To ward more open science.
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Paper presented at IOM Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting One, October 22-23, Washington, DC. Terry, S
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