PDF(Pubmed)
Abstract：
UNASSIGNED: Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trial data. However, data sharing in pragmatic clinical trials (PCTs) presents ethical challenges. While prior scholarship has described aspects of PCTs that raise distinct considerations for data sharing, there have been no reports of the experiences of those at the leading edge of data-sharing efforts for PCTs, including how these particular challenges have been navigated. To address this gap, we conducted interviews with key stakeholders, with a focus on the ethical issues presented by sharing data from PCTs.
UNASSIGNED: We recruited respondents using purposive sampling to reflect the range of stakeholder groups affected by efforts to expand PCT data sharing. Through semi-structured interviews, we explored respondents\' experiences and perceptions about sharing de-identified, individual-level data from PCTs. An integrated approach was used to identify and describe key themes.
UNASSIGNED: We conducted 40 interviews between April and September 2022. Five overarching themes emerged through analysis: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding PCT patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing PCT data; and (5) diverse views about the likely benefits resulting from sharing PCT data.
UNASSIGNED: Our data indicate unresolved tensions in how to fulfill the expectation to broadly share de-identified, individual-level data from PCTs, and suggest that those promulgating and implementing data-sharing policies must be sensitive to PCT-specific considerations. Future work could inform efforts to tailor data-sharing policy and practice to reflect the challenges presented by PCTs, including sharing experiences from trials that have successfully navigated these tensions.
UNASSIGNED: We recruited respondents using purposive sampling to reflect the range of stakeholder groups affected by efforts to expand PCT data sharing. Through semi-structured interviews, we explored respondents\' experiences and perceptions about sharing de-identified, individual-level data from PCTs. An integrated approach was used to identify and describe key themes.
UNASSIGNED: We conducted 40 interviews between April and September 2022. Five overarching themes emerged through analysis: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding PCT patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing PCT data; and (5) diverse views about the likely benefits resulting from sharing PCT data.
UNASSIGNED: Our data indicate unresolved tensions in how to fulfill the expectation to broadly share de-identified, individual-level data from PCTs, and suggest that those promulgating and implementing data-sharing policies must be sensitive to PCT-specific considerations. Future work could inform efforts to tailor data-sharing policy and practice to reflect the challenges presented by PCTs, including sharing experiences from trials that have successfully navigated these tensions.
摘要：
■已经提出了许多关于广泛共享去识别的论点，参与者级别的临床试验数据。然而,务实临床试验(PCT)中的数据共享提出了道德挑战。虽然先前的奖学金描述了多氯三联苯的各个方面，这些方面引起了数据共享的不同考虑，没有报告说，在多氯三联苯的数据共享努力方面处于领先地位的人的经验，包括如何应对这些特殊挑战。为了解决这个差距，我们采访了主要利益相关者，重点是分享多氯三联苯的数据所带来的道德问题。
■我们采用目的性抽样的方式招募了受访者，以反映受扩大PCT数据共享影响的利益相关者群体的范围。通过半结构化面试，我们探索了受访者关于分享去识别的经验和看法，来自PCT的个人数据。使用综合方法来确定和描述关键主题。
■我们在2022年4月至9月间进行了40次采访。通过分析出现了五个主要主题：（1）在放弃或更改同意下共享收集的数据方面的挑战；（2）关于PCT患者对数据共享的偏好的观点相互矛盾；（3）确定超出同意的尊重促进做法；（4）对共享PCT数据的风险或负担增加的担忧；（5）关于共享PCT数据可能带来的好处的不同观点。
■我们的数据表明，在如何实现广泛共享去识别，来自PCT的个人数据，并建议那些颁布和实施数据共享政策的人必须对PCT特定的考虑敏感。未来的工作可以为调整数据共享政策和做法的努力提供信息，以反映多氯三联苯带来的挑战，包括分享成功应对这些紧张局势的试验经验。
■我们采用目的性抽样的方式招募了受访者，以反映受扩大PCT数据共享影响的利益相关者群体的范围。通过半结构化面试，我们探索了受访者关于分享去识别的经验和看法，来自PCT的个人数据。使用综合方法来确定和描述关键主题。
■我们在2022年4月至9月间进行了40次采访。通过分析出现了五个主要主题：（1）在放弃或更改同意下共享收集的数据方面的挑战；（2）关于PCT患者对数据共享的偏好的观点相互矛盾；（3）确定超出同意的尊重促进做法；（4）对共享PCT数据的风险或负担增加的担忧；（5）关于共享PCT数据可能带来的好处的不同观点。
■我们的数据表明，在如何实现广泛共享去识别，来自PCT的个人数据，并建议那些颁布和实施数据共享政策的人必须对PCT特定的考虑敏感。未来的工作可以为调整数据共享政策和做法的努力提供信息，以反映多氯三联苯带来的挑战，包括分享成功应对这些紧张局势的试验经验。
