Optimizing Recruitment in Clinical Trials of CRVO
American Journal of Ophthalmology, October 2016
The investigators in the SCORE-CRVO trial had found timely recruitment of adequate numbers of patients to be challenging. Thus, to improve recruitment for the subsequent study (SCORE2), Scott et al. evaluated recruitment in other trials of intravitreal pharmacotherapy for central retinal vein occlusion (CRVO) and implemented techniques to optimize enrollment. They found that the recruitment rate in SCORE2 was higher than that in SCORE-CRVO (0.39 vs. 0.10 participants/month/site, respectively) and that it compared favorably to rates in previous clinical trials of intravitreal pharmacotherapy for macular edema associated with CRVO.
In addition to calculating recruitment rates, the researchers conducted a survey of the SCORE2 principal investigator and primary clinical coordinator at each study site as to the perceived impact of 4 study design features related to recruitment. These features were rated on a 5-point scale (ranging from 1 = major hindrance to 5 = major positive impact). The utility of specific communication methods also were ranked on a 5-point scale (ranging from “not at all” to “extremely” helpful/useful).
Of the 75 sites, 69 (92%) completed at least 1 survey. Mean scores showed that principal investigators and site coordinators felt positively about all 4 design features evaluated. Of these, provision of standard-of-care active treatment to all patients (i.e., no placebo group) received the highest rating (4.76), followed by SCORE supply of the study drug (4.53), ability to screen and randomize in 1 day (4.53), and allowing enrollment of patients with previous anti-VEGF treatment (4.15).
The most effective tools to aid enrollment goals included a monthly e-newsletter to site staff and congratulatory/motivational communications by physician members of the SCORE2 Executive Committee to site investigators and coordinators upon site activation and randomization.
The authors concluded that 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 optimizing recruitment in future clinical trials.
The original article can be found here.