ClinPhone Webinar Reveals Increasing Industry Focus on Adaptive Trial Design
ClinPhone’s latest educational webinar entitled “Re-designing Drug Development: Practical Application of Adaptive Trials” was attended by over 400 biopharmaceutical professionals indicating the increased industry attention and interest in these techniques. The live webinar featured case studies and discussion from Dr. Paul Saunders of Pfizer Ltd., illustrating the benefits of adaptive trials in optimal dose finding and accelerating decision making and drug development timelines.
A study design is called ‘adaptive’ if statistical methodology allows the modification of a design element, such as sample size or randomization ratio, at an interim analysis. While the use of interim analyses is not new, the option to make design modifications within a formal framework that is accepted by regulators is. Use of such designs can speed up drug development without lowering regulatory standards, but to execute them well requires good planning and the ability to maintain control of the process involved.
Centralized randomization and trial supply management using Interactive Voice Response (IVR), and data capture using EDC have a major role to play in facilitating the delivery of complex trial designs. IVR technology enables the rapid implementation of design modifications that affect the randomization of future patients. In addition IVR enables the supply chain to be automatically re-evaluated following a design change, so that sufficient medication for the remaining treatment arms is ensured at each site.
By employing a technology solution with a central distribution method – most commonly by applying an IVR system to manage trial supplies and randomization – the knowledge of any change to the allocated treatments can be kept hidden from the investigators. Thus there is no potential for bias and no reason to expect any observed differences between the before and after a design modification – something the regulators will be specifically looking for.
Dr. Bill Byrom, Product Strategy Director at ClinPhone, comments: “The framework within which we conduct clinical trials is changing, and adaptive trials offer exciting opportunities to enhance the way drug development is conducted. Technology plays a vital role in delivering these new kinds of studies, and ClinPhone is leading the way in delivering integrated products with the enhanced functionality required by these complex designs.”
