The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) is hosting a two-day virtual workshop titled “Optimizing Oversight of Implementation Science Clinical Trials: Sharing Best Practices & Lessons Learned in a Virtual Workshop” on Wednesday, December 6th, from 11:00am – 4:00 pm and Thursday, December 7th, 2023,from 11:00am – 4:00 pm US EasternTime.
As the field of Implementation Science (IS) enters its third decade as a formalized science, there is sufficient evidence and experience to suggest that its targets and focus are substantively different than clinical trials for which existing oversight guidelines were established. Clinical trials to advance Implementation Science typically test strategies to integrate evidence-based interventions (EBI) targeting different participants (e.g., providers, care teams, community organizations) to achieve outcomes related to the EBI delivery. This workshop is crucial for convening experienced academic health center and community partners in surfacing the unique challenges and opportunities to inform the oversight requirements, operationalization, dissemination, and execution of IS clinical trials. The information gained could help accelerate the refinement of policies and procedures developed by NHLBI and other Institutes, Centers, and Offices. To this end, this workshop is instrumental in laying the foundation for future development of standardized procedures for providing focused oversight of IS clinical trials that ensure the safety of study participants and the accuracy of data acquired, particularly in low resource settings (Bauer et al., 2015).
Workshop Objectives:
The goal of this workshop is to advance the field of Implementation Science (IS) by sharing best practices and lessons learned in the oversight of IS clinical trials. Central to our mission is the unwavering commitment to participant safety and the integrity of data, recognizing that these elements are the bedrock upon which trust in clinical research is built. Such trust is vital when transitioning EBIs from research settings into routine clinical and public health practice. Our specific objectives are :
1) To engage partners including principal investigators, clinicians, ethicists, community leaders, policy makers, and funders in a comprehensive dialogue about the unique challenges and opportunities associated with IS clinical trials oversight to foster active participation in solutions.
2) To explore the aspects of IS clinical trials that might warrant a different monitoring/oversight approach than traditional efficacy/effectiveness clinical trials due to the unique nature of IS through the following sessions:
- Session 1: Implementation of Science Monitoring Plans and Oversight
- Session 2: Implementation Science Trial Designs and Protocol Development Considerations
- Session 3: Implementation of Science Clinical Trials in Low Resource Settings
- Session 4: Defining Adverse Events, Serious Adverse Events, & Unanticipated Problems
*This workshop is private and will be recorded for the use of the NIH Community only
Accommodations
Individuals with disabilities who need Sign Language Interpreters and/or reasonable accommodation to participate in this event should contact Deidre O'Neill at NHLBIWorkshopSupport@nih.gov. Requests need to be made five (5) days in advance.
Contact
For logistical questions, email Deidre O’Neill at NHLBIWorkshopSupport@nih.gov. For programmatic questions, email Workshop Organizer Veronica Tonwe veronica.tonwe@nih.gov and Cara C. Lewis at cara.lewis@nih.gov
