Running clinical trials that include multiple sites but very few patients brings unique challenges. The trials are often the crucible from which scientific discovery emerges, but can be challenging to manage.
The Small Trials Program (STP) offers a “one-stop shop” for trials that involve two to 10 research sites and fewer than 100 participants.
The STP brings together a team of experts to guide these specialized research efforts, from design to regulatory submission. The overarching goal of the STP is to create a cost-effective and feasible platform for efficiently conducting such trials.
Resources provided by the Small Trials Program include:
- Development of novel study designs
- Data capture and management
- Analytic expertise
- Project management
- Site management and monitoring
- Safety assessment
- Regulatory submissions and publications.
STP team members are cross-trained in all aspects of small trial conduct, ensuring an efficient and effective experience for investigators. A DCRI Business Development representative manages project budgets to provide financial oversight and accountability.
To contact the STP program about a proposed research project, email DCRI-PMC@dm.duke.edu or call Anthony Cunningham at 919-668-8320.