Randomization is a core component in the design and implementation of RTSM in clinical trials. Two of the most important elements to the integrity of a controlled clinical study are the patient randomization and the treatment blinding, and the RTSM system is the backbone supporting these controls. In the February issue of Applied Clinical Trials, Bracket’s Dr. Scott Hamilton contributes to an article describing the results of a simulation study comparing a novel randomization procedure with a more traditional procedure. In this case, the authors compared two forms of utilizing block pattern distribution, which can minimize selection bias in a randomization scheme.
Bracket developed Precision Block Design™ for sponsors who want or need to utilize block pattern distribution in their randomization lists when using Bracket RTSM™. The use of Precision Block Design™ does not add additional time nor cost to the creation of the randomization list. For more information about selection bias and/or Precision Block Design™ you can download our brief whitepaper on the topic here, or contact Bracket for more details.
Full article here.
FULL CITATION: A Comparasion of Techniques for Creating Permuted Blocked Randomization Lists.Applied Clinical Trials. 2016 Feb 12.
JOURNAL: Applied Clinical Trials
AUTHORS: Carol Shum, Scott Hamilton, PhD, Kim Hung Lo
The International Society for CNS Clinical Trials and Methodology (ISCTM) 12th Annual Scientific Meeting takes place February 16–18 in Washington, DC. Bracket is a Sustaining Member of the society, which is “devoted to promoting advances that address strategic clinical, regulatory, methodological and policy challenges that arise in the development and use of CNS therapeutic agents.” At this year’s meeting, Bracket will be presenting new research related to our eCOA and Quality Assurance work. You can find more information about the agenda here.
Below are the scientific posters Bracket is presenting for ISCTM.
Wednesday, February 17
Poster Session (6:00pm to 8:00pm)
Early Indicators of Poor Data Quality in Schizophrenia Clinical Trials
Alan Kott, David Daniel
What blinded raters don’t see: Relapse events in a bipolar study detected by Site-based raters versus a Computer Simulated Rater
Gary Sachs, Amy Peters
Bracket is pleased to announce that the company will be participating in two conferences this February – Dpharm Europe in London and Outsourcing in Clinical Trials – West Coast in California. Information regarding both conferences can be found by clicking on the links below.
2nd Annual DPharm Europe: Disruptive Innovations to Advance Clinical Trials in London, UK
The 2nd annual DPharm Europe: Disruptive Innovations to Advance Clinical Trials will be taking place the 9th of February to the 10th at the St. Pancras Renaissance Hotel in London, United Kingdom. This conference will cover many topics that will ultimately transform drug development and the industry. On the first day of this conference, Adam Butler, will present a brief case study on utilizing a BYOD mobile app to ensure patient safety, improve site efficiency, and give patients the flexibility to report data using their own smart phones.
If you are interested in attending, our referral code for registration is BRKT25. Please be sure to come see us at booth 9! More details on the conference here.
Outsourcing in Clinical Trials – West Coast in San Mateo, California
Bracket is exhibiting at the Outsourcing in Clinical Trials – West Coast event in San Mateo, California on the 10th of February to the 11th. This two-day conference will be held at the San Mateo Event Center and will cover the latest challenges, trends and innovation in clinical operations, outsourcing and development. If you plan on attending, stop by booth 84 to see what we are offering!
More information on the conference here.