Related Experiment Video
Updated: Jun 30, 2025
A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Developing Guidance for Donor Intervention Randomized Controlled Trials: Initial Discussions From the Canada-United
Marat Slessarev1,2,3, Katie L Bain2, John Basmaji1
1Department of Medicine, Western University, London, ON, Canada.
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.
Insights
Donor interventions can improve organ transplantation but require guidance. A Canadian-UK expert workshop identified challenges and developed a research agenda for donor intervention randomized controlled trials (RCTs).
Area of Science:
- Transplantation research
- Medical ethics
- Clinical trial design
Background:
- Donor interventions can improve organ quality and quantity for transplantation.
- Limited high-quality evidence exists on donor intervention effectiveness due to ethical and practical challenges.
- Lack of guidance hinders the conduct of donor intervention randomized controlled trials (RCTs).
Purpose of the Study:
- To develop authoritative guidance for conducting donor intervention RCTs.
- To identify stakeholders, challenges, and research priorities in donor intervention research.
- To inform future work in enhancing organ donation and transplantation outcomes.
Main Methods:
- Convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation.
- Focused on ethics, research, and policy related to donor interventions.
- Identified stakeholders and explored unique challenges in the field.
Main Results:
- Donor intervention trials must consider diverse stakeholder perspectives.
- Key challenges include research ethics (consent, harm-benefit), data standardization, and regulatory issues.
- A research agenda was developed to address these identified challenges.
Conclusions:
- Donor intervention RCTs offer potential benefits for organ transplantation.
- Unique ethical, data, and regulatory challenges must be addressed.
- The workshop represents a first step toward developing Canada-UK guidance for donor intervention RCTs to improve organ quality and availability.
More Related Videos
06:16Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
Published on: June 6, 2020
09:34Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease
Published on: April 4, 2018
Related Concept Videos
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:13Randomized Experiments
Simple randomization
Simple...
01:11Blinding