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.
Bracket, with seven offices and more than 500 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs. Learn more about Bracket at www.bracketglobal.com.