Bracket, a clinical trial technology and specialty services provider, has randomized its first patient using Precision Block Design (PBD) technology integrated in its clinical IRT platform, including its mobile application. The first RTSM provider to develop and utilize the novel PBD method, Bracket is minimizing selection bias, reducing predictability of treatments and improving patient randomization by balancing known and unknown prognostic factors across comparative groups.
“The statistics group at Bracket is committed to generating the highest quality randomization lists and the development of Precision Block Design is a true testament to their dedication,” said Jeff Kinell, CEO at Bracket. “This technology ensures block patterns are uniform and we look forward to maintaining the integrity of controlled clinical studies through this innovative solution to patient randomization.”
Randomization is a core component in the design and implementation of RTSM in clinical trials and Bracket developed PBD for sponsors who want or need to utilize block pattern distribution in their randomization lists when using Bracket RTSM. Randomization designs including those with a high number of strata or low number of slots lend themselves best to the utilization of this method.
To ensure equal representation across all permutations, PBD guarantees a uniform distribution of block patterns within each stratum. As a result, PBD does not require acceptance tests nor does it add additional time or costs to the creation of the randomization list. These benefits make PBD a win-win solution as it reduces selection bias and predictability while maintaining time and cost efficiencies.
“At Bracket, we’ve created new programming standards, crafted training, updated standard system requirements, and modified our SOPs. Maintaining the maximum level of integrity in our randomization technology is our highest priority,” said Dr. Scott Hamilton, principal biostatistician at Bracket.
To date, PBD has been successfully utilized by Bracket in four separate clinical trials.