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Chris Coffey, professor of biostatistics, will present "We Built This Network: How NeuroNEXT Increases Innovative Design in Academic Trials." A reception will follow the lecture.

The traditional approach to clinical trials tends to be large, costly, and time-consuming. Correspondingly, there is a need for more efficient clinical trial design, which has recently led to substantial interest in the use of innovative trial designs.

For example, adaptive designs allow reviewing accumulating information during an ongoing clinical trial to possibly modify trial characteristics. Although there are a large number of proposed adaptations, regulatory groups support the notion that all changes should be based on pre-specified decision rules. This often requires research groups to condbuct properly designed simulation studies in order to confirm that the proposed adaptations preserve the integrity and validity of the study.

To address this issue, there has been an industry movement towards creating in-house teams primarily responsible for planning and conducting such simulations. Greater barriers exist for implementing this same type of infrastructure within the academic clinical trials environment. For example, the simulations would need to be conducted before the design is finalized – which must occur well before a typical grant submission to support funding for a proposed trial. For researchers who are completely grant-funded, few mechanisms exist to support these complex simulation studies.

As a result, there is a growing divide between the practicality and feasibility of conducting adaptive designs in industry compared to academia. Since acceptance of adaptive designs in general will depend on increasing their use across all types of clinical trials, infrastructure-building efforts are needed within the academic clinical trials environment in order to help further advance the use of adaptive designs.

One recent example of such an effort is the creation of the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). The Network infrastructure provides support for a group of senior statisticians with a great deal of experience in protocol and grant development for clinical trials. This infrastructure dramatically increases the feasibility for using more novel trial designs – including adaptive designs.

In this presentation, Dr. Coffey will provide a summary of the NeuroNEXT experience to date and illustrate how initiatives like NeuroNEXT greatly increase the practicality of using adaptive designs in an academic trials setting.