Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research

Morain, Stephanie R.; Mathews, Debra J. H.; Geller, Gail; Bollinger, Juli; Weinfurt, Kevin P.; Jarvik, Jeffrey G.; May, Elizabeth; Sugarman, Jeremy

doi:10.1016/j.hjdsi.2021.100586

Cited by 3 publications

(5 citation statements)

References 24 publications

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“…Qualitative research suggests that many researchers view the management of collateral findings as an inappropriate intrusion into clinical care and better viewed as the responsibility of clinical and operational systems. 5 Yet, early reports suggest a lack of agreement about responsibility for collateral findings, raising concern that important clinical signals discovered through ePCTs might be overlooked. 5 Finally, managing collateral findings may present a resource issue for ePCTs that are large in scale, resulting in considerable costs for health systems, as well as burdens on their clinicians.…”

Section: Challenge 2: Collateral Findings In Pctsmentioning

confidence: 99%

“…5 Yet, early reports suggest a lack of agreement about responsibility for collateral findings, raising concern that important clinical signals discovered through ePCTs might be overlooked. 5 Finally, managing collateral findings may present a resource issue for ePCTs that are large in scale, resulting in considerable costs for health systems, as well as burdens on their clinicians. These clinicians might be tasked with consulting affected patients about the implications of collateral findings (despite those clinicians not being involved in nor potentially even aware of that research).…”

Section: Challenge 2: Collateral Findings In Pctsmentioning

confidence: 99%

“…3 Elsewhere, we have provided guidance about the importance of prospective planning for collateral findings. 5 While there is no one-size-fits-all solution, several factors should be considered, including the clinical relevance and medical actionability of the findings, the amount of time between data collection and collateral finding identification, whether the information is uniquely known by the study team, the system-level impact of disclosure and any subsequent clinical management, and whether prospective consent was obtained. 5 Given the implications for the health care systems into which ePCTs are embedded, health care system leadership must be key partners in planning for and responding to collateral findings.…”

Section: Challenge 2: Collateral Findings In Pctsmentioning

confidence: 99%

See 2 more Smart Citations

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials

Propes,

O’Rourke,

Morain

2024

Circ: Cardiovascular Quality and Outcomes

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Section: Challenge 2: Collateral Findings In Pctsmentioning

confidence: 99%

Section: Challenge 2: Collateral Findings In Pctsmentioning

confidence: 99%

Section: Challenge 2: Collateral Findings In Pctsmentioning

confidence: 99%

See 1 more Smart Citation

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials

Propes,

O’Rourke,

Morain

2024

Circ: Cardiovascular Quality and Outcomes

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“…The challenges presented by sharing data from clinical trials, including those involving genetic and genomic data, as well as the ethical challenges associated with the design and conduct of PCTs have been extensively explored. [7][8][9][10][11][12][13] Yet the particular challenges for PCT data-sharing efforts are not widely recognized. While most trials are neither fully explanatory nor fully pragmatic, but instead lie on a spectrum, 14,15 there are nevertheless some features common to many PCTs that raise distinct considerations for data sharing.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements

Morain

Bollinger

Weinfurt

et al. 2023

Learning Health Systems

Self Cite

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IntroductionNumerous 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.MethodsWe 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.ResultsWe 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.ConclusionOur 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.

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Ethical considerations for sharing aggregate results from pragmatic clinical trials

Morain,

Brickler,

Ali

et al. 2024

Clinical Trials

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A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no prior work has examined these issues in the context of pragmatic clinical trials. Several characteristics of pragmatic clinical trials may complicate both the ethics and the logistics of sharing aggregate results. Among these characteristics include that pragmatic clinical trials may affect the rights, welfare, and interests of not only patient-subjects but also clinicians, meaning that results may be owed to a broader range of groups than typically considered in other research contexts. In addition, some pragmatic clinical trials are conducted under a waiver of informed consent, meaning sharing results may alert participants that they were enrolled without their consent. This article explores the ethical dimensions that can inform decision-making about sharing aggregate results from pragmatic clinical trials, and provides recommendations for that sharing. A central insight is that healthcare institutions—as key partners for the conduct of pragmatic clinical trials—must also be key partners in decision-making about sharing aggregate pragmatic clinical trial results. We conclude with insights for future research.

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Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research

Cited by 3 publications

References 24 publications

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials

Stakeholder perspectives on data sharing from pragmatic clinical trials: Unanticipated challenges for meeting emerging requirements

Ethical considerations for sharing aggregate results from pragmatic clinical trials

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