01 Feb 2021
Diabetic Retinopathy Case Study
TFS was selected as the rescue CRO to provide services for a biotech/clinical research center collaboration, to develop topical therapy for neurodegeneration, as an early event in the pathogenesis of diabetic retinopathy (DR). Eligible patients were randomized in a 1:1:1 ratio to one of three treatment arms. The randomization was fully masked for the central reading center, to reduce bias, but open label for one IMP arm for investigators and patients.
A study with a usual complex design and procedures: Color Fundus Photography, Visual Field Test, SD-Optical Coherence Tomography (SD-OCT), Multifocal Electroretinography, BCVA, VFQ-25, vendor management. TFS was the CRO of choice based on extensive experience and delivery of ophthalmology studies.
- Study Phase: II-III
- Indication: Diabetic Retinopathy
- Sites: 11
- Services: Project management, site management, regulatory, TMF and medical writing
- The study was behind schedule in some countries, including submissions and enrollment. Enrollment forecasts particularly with some KOL sites were initially unrealistic. Additionally patient retention was at risk owing to the study duration and complex procedures.
- Roles and responsibilities between TFS and the sponsor and associated departments were unclear causing inefficiencies.
- The site management and communication was poor.
- OCT technician turnover was very high at some sites. Resulting in poor or inconsistent quality imaging, late imaging and the need for repeated assessments to be performed, also leading to many protocol deviations.
- Site adherence to protocol was somewhat compromised due to complex procedures and training deficiencies.