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March 28, 2024

 

More research needs to be done on how to more efficiently recruit centers to participate in RCTs, experts say.

 

Randomized trials may be better equipped to select participating sites if they base recruitment on expertise in treating the condition being studied, according to details from the CREST-2 study that were published online August 2, 2017, ahead of print in Stroke.

CREST-2 investigators, led by Bart M. Demaerschalk, MD (Mayo Clinic, Phoenix, AZ), documented several metrics among the 147 trial sites, including the median time between site selection and authorization to randomize, the median time between authorization to randomize and the first randomization, and the average number of randomizations per site per month.

 

Timing of Randomization and Recruitment

Median Time from Site Selection to Authorization to Randomize (IQR)

9.9 months (7.7, 12,4)

Median Time Between Authorization to Randomize and Randomization (IQR)

4.6 months (2.6, 10.5)

Recruitment Rate (95% CI)

0.26 patients/site/month (0.23-0.28)

 

Next, the investigators examined several factors to determine which might influence timing of randomization and recruitment. These comprised characteristics of the site, specialty of the principal investigator, and site type (eg, presence of affiliated recruitment sites and a full complement of study investigators, membership in StrokeNet, use of a central institutional review board, annual number of carotid endarterectomy procedures performed, potential to enroll women and minorities, type of study approval sought, and participation and actual performance in CREST).

Of these factors, authorization to randomize in only the carotid endarterectomy study was associated with being slower to randomize.

In addition, the following factors were significantly linked with faster recruitment times:

·       Authorization to randomize in both trials

·       Principal investigator specialties of interventional radiology and cardiology

·       Pretrial reported performance > 50 carotid angioplasty and stenting procedures per year

·       Status in the top half of recruitment in the CREST trial

·       Classification as a private health facility

 

Interestingly, participating in StrokeNet was associated with slower recruitment as compared with not being in that network.


A Step Toward Preferential Recruitment

The authors acknowledge that there remains a lack of information on how to preferentially recruit high enrollment sites in clinical trials, but say their study represents a first step.

“These findings suggest that much more needs to be learned about factors associated with sites that will move rapidly to randomization,” they write. “However, powerful factors associated with sites’ early recruitment rate in CREST-2 were identified. Collectively, these observations suggest that the selection of sites for high recruitment may need to be targeted and tailored to the treatment under assessment. Targeting sites in this manner could improve the efficiency of future clinical trials.”

In an accompanying editorial, Robert J. Goldberg, PhD (University of Massachusetts Medical School, Worcester, MA), and Hoa L. Nguyen, MD, PhD (Baylor Scott & White Health, Dallas, TX), also point out that there is a paucity of data describing the site selection process involved in multicenter randomized controlled trials and the factors that influence efficient recruitment.  

“The findings of this article have direct relevance for trial investigators, project management personnel, and funding agencies,” they write, explaining that the results “provide insights into the time course from the time of initial site selection to actual patient randomization and some of the site, as well as investigator, factors associated with early site start-up and patient enrollment.”

The editorialists call for collection of additional data on recruitment, activation, and randomization in different settings and content areas in order to better inform the development future randomized controlled trials.

 


 

Sources:

  • Demaerschalk BM, Brown RD Jr, Roubin GS, et al. Factors associated with time to site activation, randomization, and enrollment performance in a stroke prevention trial. Stroke. 2017;Epub ahead of print.
  • Goldberg RJ, Nguyen HL. Unlocking the keys to site activation and recruitment success in a randomized controlled trial. Stroke. 2017;Epub ahead of print.

 

Disclosures:

 

Demaerschalk, Goldberg, and Nguyen report no relevant conflicts of interest.