AI Article Synopsis
- Donor interventions can potentially improve the quality and quantity of transplantable organs, but there's limited high-quality evidence due to ethical, practical, and regulatory challenges.
- A workshop of experts from Canada and the UK aimed to create guidance for conducting randomized controlled trials (RCTs) in this area, focusing on identifying stakeholders and unique challenges in donor intervention research.
- Key challenges include navigating research ethics, standardizing outcome data, and addressing regulatory issues, but addressing these can lead to better organ transplantation outcomes through well-designed donor intervention RCTs.
Article Abstract
Background: Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs).
Methods: With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field.
Results: Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations.
Conclusions: Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs.
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| http://dx.doi.org/10.1097/TP.0000000000004983 | DOI Listing |
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