SCORE2 Report 1: Techniques to Optimize Recruitment in Phase III Clinical Trials of Patients with Central Retinal Vein Occlusion

• Published in: American journal of ophthalmology 2016-10, Vol.170, p.25-31
• Main Authors: Scott, Ingrid U., MD, MPH, VanVeldhuisen, Paul C., PhD, Ip, Michael S., MD, Blodi, Barbara A., MD, Oden, Neal L., PhD, Figueroa, Maria, MBA
• Format: Article
• Language: English
• Subjects: Angiogenesis Inhibitors - therapeutic use; Bevacizumab - therapeutic use; Clinical trials; Communication; Drug therapy; Edema; Enrollments; Health Communication - methods; Humans; Intravitreal Injections; Likert scale; Macular Edema - drug therapy; Ophthalmology; Patient Participation; Patient Selection; Patients; Pharmaceutical industry; Receptors, Vascular Endothelial Growth Factor - therapeutic use; Recombinant Fusion Proteins - therapeutic use; Retinal Vein Occlusion - drug therapy; Retrospective Studies; Studies; Vascular endothelial growth factor; Vascular Endothelial Growth Factor A - antagonists & inhibitors
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2016.07.011

Abstract Purpose To investigate recruitment rates of patients with central retinal vein occlusion (CRVO) into phase III clinical trials evaluating intravitreal pharmacotherapy for treatment of macular edema in the United States, describe recruitment techniques in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2), and assess which SCORE2 recruitment techniques were most useful to principal investigators and clinical coordinators. Design Retrospective survey within a randomized clinical trial. Methods Recruitment rates of the Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE)-CRVO trial, CRUISE Study and SCORE2 were calculated. Techniques employed to facilitate recruitment in SCORE2 are described, and a survey was sent to the principal investigator and primary clinical coordinator of each SCORE2 site to assess the usefulness of recruitment techniques. Results In SCORE2, the recruitment rate of 0.39 participants/month/site was higher than in SCORE-CRVO (0.10 participants/month/site) and CRUISE (0.23 participants/month/site). For study design factors in SCORE2, investigators and coordinators rated provision of standard of care treatments to all study participants as having a major positive impact on recruitment. A monthly e-newsletter to site staff and communication by physician members of the SCORE2 Executive Committee to sites upon each randomization were perceived as effective means to help site staff focus on recruitment. Conclusions The SCORE2 recruitment rate compares favorably to previous clinical trials investigating intravitreal pharmacotherapy for treatment of CRVO-associated macular edema. Study design factors, methods of communication with sites and recruitment techniques implemented in SCORE2 were well received by investigators and coordinators and may be helpful in future clinical trials.