The Clinical Trials Transformation Initiative (CTTI) released the recommendations at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, which took place last week in Florida.
CTTI was co-founded by Duke University and the US Food and Drug Administration (FDA).
The new recommendations focus on four areas:
- Developing site-based research infrastructure and staff
- Optimizing trial execution and conduct
- Improving site budget and contract negotiations
- Discovering additional trials to conduct
Gerrit Hamre, project manager at CTTI said the evidence-based solutions can be implemented across the clinical trial enterprise, including sponsors, contract research organizations (CROs), as well as the site investigators.
“By creating a supportive clinical research ecosystem—one that provides adequate infrastructure and staff, continuous training, clear operational and financial procedures, and a climate of mutual respect—investigators will feel more engaged and empowered to continue working in the clinical research space,” he told Outsourcing-Pharma.com.
A balancing act
Many investigators leave clinical research due to a difficulty balancing workload, time requirements to conduct trials, data and safety reporting burdens, and financial issues, Hamre explained.
“However, the professional and personal rewards of conducting research are also evident, and the ability to overcome challenges associated with clinical research is clearly articulated,” he added.
The goal of the new recommendations is to provide “a roadmap to address these challenges and, ultimately, decrease the number of ‘one and done’ investigators,” said Hamre.
The project was funded in part by the US FDA grant.