ARVO Annual Meeting 2018

Topic:

A Vertically-Integrated Delivery Model for Retina Clinical Studies

Abstract:

It is well-documented that clinical studies are regularly completed behind schedule. Research programs are plagued by protracted study startup, “one-and-done” investigators or sites that do not enroll sufficient subjects and unpredictability for subject recruitment, all leading to material overruns in study timelines and costs. For clinical research in retina and complex ophthalmic indications, these results are further compounded by the added entry qualifications for study sites – ocular imaging, facility certifications, masking procedures, etc. – and relatively low enrollment per site, often 6 or fewer patients per enrollment year. We have developed a unique delivery model that aims to address these challenges by integrating services among high performing study sites, a global ocular imaging reading center, a central IRB and the CRO servicer. Through this unique ‘Catalyst” model, we have achieved faster study startup and completion compared to non-integrated studies. The Catalyst program is by invitation only, study sites with a proven track record of delivering on time and quality are considered for the model which includes pre-agreed service, contractual, and financial terms. Through these deep and proven relationships, the ‘Catalyst’ model provides improved predictability for study Sponsors with the highest levels of quality. This presentation aims to further explain the makeup and value of this ‘Catalyst’ model.

Presenters:

Nicholas Spittal, MBA, PMP, Vice President Clinical Development Dr. Sonia Pal, Project Director, CNS