To ensure patient safety, efficacy and data integrity, we have seen a growing emphasis placed on the statistical monitoring of clinical trials. Currently, data safety monitoring boards (DSMBs) play a key role in monitoring safety and scientific rigor throughout the course of a trial. Increasingly DSMBs are also tasked with reviewing interim analyses of efficacy to uncover evidence of overwhelmingly effective or ineffective treatment outcomes. Unearthing the efficacy profile of a drug early on during a trial can allow for trial modifications that can lead to reassignment of patients to the more effective treatment groups or elimination of ineffective treatment groups, which can ultimately benefit patients and help sponsors avoid unnecessary research expense.
As a non-profit independent research organization, we provide impartiality in our mid-trial statistical services, which is vital to maintaining the integrity of the trial. We maintain an academic orientation to research where scientific credibility and ethical standards guide our work. Our biostatisticians all hold graduate degrees and are well-versed in both fundamental and advanced statistical methods, so your data will be analyzed correctly. Below you will find more information about our mid-trial statistical support services.
Adaptive Design Statistical Support
Adaptive study designs are gaining support within the industry and the FDA. Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the FDA, said at the 2006 Conference on Adaptive Trial Design, “These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments, and resulting in clinical trials that may not only be more efficient but are more attractive to patients and their physicians to enroll in. FDA is taking some new steps right now to help facilitate the continued development of these newer, more adaptive clinical trials, and the opportunity couldn’t be riper.” In mid-2006, the FDA committed to drafting official guidance documents on the topic of adaptive designs, which can provide a number of benefits, including:
Earlier drug safety and efficacy information
Greater chance for effective drugs to benefit more people faster, both during the trial and post-approval
Less chance for patient exposure to ineffective or unsafe experimental medications
Ethical and cost benefits
More safety information on the more effective treatment
Better understanding of efficacy between patients and proper dosing levels
Our expert biostatisticians can provide independent interim analyses for your adaptive clinical trials to ensure unbiased results. We help you design adaptive trials, analyze interim data, provide guidance on next steps and assist regulatory and interim reporting of the analyzed results.
Statistical Analysis Support to DSMBs
Regardless of the trial design, whether adaptive or group sequential, we can provide interim analysis to DSMBs. This will allow your statisticians to remain blinded to interim results. We can provide all the analyses pre-specified by the DSMB and respond to their requests for additional analyses.
