(Durham, N.C.; March 19, 2013) — Implementing the optimum strategy for patient randomization and drug management though the use of interactive response technology can greatly reduce waste and improve efficiency in blinded clinical trials. However, IRT can increase the risks of partial unblinding unless those risks are minimized through careful design of the drug supply/resupply and patient/drug assignment aspects of the system.
In a new, on-demand webinar, Stefan Duerr, associate director of project management at Cenduit LLC, describes ways unblinding can occur during a study and warns that even partial unblinding can seriously compromise data.
Titled “Avoid Unblinding Risks when Defining Drug Supply Strategy in an IRT System,” the webinar points out that investigators or other site staff often unwittingly obtain information that enables them to guess the treatment of a patient with higher probability than if based on chance alone.
“The difficulty is that an investigator with some unblinding clues may, consciously or unconsciously, begin to look for corroborating evidence, and over time the accuracy of his or her guesses improve,” Duerr said.
Duerr’s recommendations in the webinar include taking steps to ensure that communications reach their intended audience and making certain that the treatment group list and the medication list are kept separate and randomly assigned.
“Particularly when drugs are being resupplied to a site or supplied in response to a specific event, dispensing based on the same sequence as the kit list can easily give investigators clues that can potentially lead to biased behavior,” Duerr said.
The webinar is free and can be viewed at any time by clicking this link or by visiting the Cenduit website at www.cenduit.com.
About Cenduit LLC
Cenduit provides interactive response technology (IRT) - driven services for clinical trials around the world. Cenduit’s IRT solutions deliver optimized clinical supply chain management and facilitate precise control over patient randomization and drug administration to enable more efficient, compliant trials. With expert personnel located around the globe, Cenduit’s unprecedented level of support currently covers more than 16,000 sites in more than 100 countries. Focus on trials, not tribulations, with Cenduit. For more information or to connect with Cenduit, visit www.cenduit.com.