Applied Clinical Trials
This Monday morning session was packed with attendess and offered them the reasons why clinical trial technology integration is important, as well as case studies and a look at adaptive trials.
Bill Byrom, PhD, Senior Director of Product Strategy for Perceptive Informatics, and session chair, noted the current challenges of the current ways that data is collected and managed. By way of example, he cited a Belgium site that was running seven trials and using 17 different pieces of technology to support those trials. Currently, CTMS, RTSM, EDC, MI, and ePRO can have different log-ins, different databases, different navigations and a different look and feel, making it extremely difficult to integrate the information.
To get more value from the data, and to inform actual decisions within a trial, Becky Wilgus, Project Lead, Clinical Research Informatics for Duke Clinical Research Institute, looked at why and how implementing decision support tools are important to clinical research. Basically, timely resolution of issues within the trials improves data quality. Her example outlined a global Phase III study of 1,100 patients with seven monitored visits per patient. These included managing 17,000 lab results and used 4,000 computer assisted recommendations. In their decision support tool implementation, she said one of the lessons learned was to have expert clinician participation at every stage. In sum, "A well-designed EHR-style decision support can support increasingly complex monitoring requirements of patient-centric trial designs."
Closing out the session was Maulik Shah, Senior Vice President of MaxisIT, who offered that adaptive trial design can drive dose or treatment-plan decisions earlier in the process and the success of an adaptive trial is dependent on many factors-a key factor being timely, accurate, authoritative, and confirmed data. The challenges currently in the successful use and/or implementation of adaptive clinical trials is with people, process, and platform. Meanwhile, FDA has issued a draft guidance on adaptive trial design that Shah says emphasizes documentation and controlled communication. He also said that FDA looks that each decision needs to be supported by strong evidence and offer a prospective plan that indicates the why, what, who, when, and how of an adaptive trial.