Setting Up Early Stage Clinical Trials

How much effort do you need to invest upfront in the design of your clinical trial/ Which process are you following to select your sites? How do you ensure compliance?

The number of registered clinical trials has been increasing steadily from 83,000 in 2010 to 210,000 in March 2016 (33,000 of which are Phase 0 and I studies) while R&D spending for clinical trials has not grown as rapidly.

The increasing complexity of clinical trials and of the underlying science suggests that more time, more highly trained personnel, and more sophisticated equipment may be required to conduct a typical study, bringing the cost per clinical trial up. The Bureau of Labor statistics shows that the average annual growth rate for Phase I clinical trial was close to 9% in the period 2000-2011. This resulted in increasing pressure on sponsor companies to run more efficient and faster clinical trials while meeting the stricter regulatory environment and providing higher data quality.

With 17% of registered clinical trials being early phase studies, we asked experts from the sponsor and CRO worlds to share their knowledge on how to best set up and manage early stage clinical trials to meet this difficult environment. They will explore some of the challenges small and start-up biotechs face when launching clinical development programs:

• How to manage the heavy workload and high expectations with limited resources
• How to run efficient clinical trials without having access to all the necessary tools
• How to ensure compliance and data quality while controlling costs
• How to manage the risks associated with being a smaller, early-stage company

Panelists

• Dr. Henk Andre Kroon, Executive VP and Chief Medical Officer, Hallux Inc.
• Thomas M Tremblay, Registered Nurse and Head of Clinical Operations, Apexigen Inc.
• Kristin Crosland, Chief Operating Officer, Experien Group
• Eric Morrie (Moderator), Director of Product Operations, ClinCapture