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

Ingrid U. Scott, Paul C. VanVeldhuisen, Michael S. Ip, Barbara A. Blodi, Neal L. Oden, Maria Figueroa

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)25-31
Number of pages7
JournalAmerican Journal of Ophthalmology
Volume170
DOIs
StatePublished - Oct 1 2016

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Retinal Vein
Retinal Vein Occlusion
Phase III Clinical Trials
Research Personnel
Macular Edema
Standard of Care
Communication
Clinical Trials
Drug Therapy
Therapeutics
Random Allocation
Patient Selection
Adrenal Cortex Hormones
Randomized Controlled Trials
Physicians

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

Scott, Ingrid U. ; VanVeldhuisen, Paul C. ; Ip, Michael S. ; Blodi, Barbara A. ; Oden, Neal L. ; Figueroa, Maria. / SCORE2 Report 1 : Techniques to Optimize Recruitment in Phase III Clinical Trials of Patients With Central Retinal Vein Occlusion. In: American Journal of Ophthalmology. 2016 ; Vol. 170. pp. 25-31.
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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.",
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SCORE2 Report 1 : Techniques to Optimize Recruitment in Phase III Clinical Trials of Patients With Central Retinal Vein Occlusion. / Scott, Ingrid U.; VanVeldhuisen, Paul C.; Ip, Michael S.; Blodi, Barbara A.; Oden, Neal L.; Figueroa, Maria.

In: American Journal of Ophthalmology, Vol. 170, 01.10.2016, p. 25-31.

Research output: Contribution to journalArticle

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AU - Ip, Michael S.

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AU - Figueroa, Maria

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N2 - 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.

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