Bryan Clayton, Vice President, Strategic Solutions

CBI’s Annual IRT Conference opened to a packed house on Monday, Oct 22. Conference Chairman Craig Mooney kicked off the two-day event with a summary of emerging trends, as well as calls to action for sponsors and vendors. Hot topics and themes at this year’s conference included:

  • New approaches to supply chain management
    • Imran Shakur from Biogen and Chad Sklodosky from Pfizer discussed how blockchain technology can effectively address clinical supply chain challenges, notably opacity, inefficiency and mistrust. Sharing findings from the Clinical Supply Blockchain Working Group (with broad representation from sponsors, CMOs, CROs, academic sites and one courier), the initial project focused on developing a workflow from warehousing to clinical sites. The long-term vision of this group (extending to 2023) is to provide end-to-end visibility to the patient, and full interoperability for all supply chain stakeholders.
    • IRT functionality to support drug pooling strategies and supply management by program, for the ability to easily allocate supplies across multiple trials and to support multiple types of trials. Drug pooling offers benefits of simplified logistics and cost savings, among others.
    • Temperature Management. Jon Paras discussed Amgen’s exploratory use of kit-level monitors to enhance supply chain visibility. Stating that 80% of the company’s product portfolio is refrigerated, he concluded that early results have been promising, and bluetooth-enabled temperature monitors provide an easy way to check drugs via mobile app before drug dispensation. This promises to be an effective replacement for a complex, manual process. The future roadmap includes the ability to support direct-to-patient shipments.
  • Flexibility and configurability. Protocol amendments are the new normal, as is the need to support ever-expanding protocol complexity, and the ability to make changes quickly. For most drug developers, speed is equally important as flexibility. There was a lot of talk about agile methodologies (including my presentation). We learned how agile methodologies support configuration, and how configuration supports agile methodologies. During panel discussions, there was broad consensus on the notion that while no system is 100% configurable, configurability is extremely valuable for its ability to save time, reduce cost and lower risk. Megan Dunham of Genentech advised the audience to keep an open mind with customization, as protocol complexity often requires some level of customization.
  • Connected data. There is a clear recognition of the need to move away from IRT as a monolithic system into a unified platform of all clinical trial data, that allows for a single source of truth. Many presenters reinforced how connected data allows for better forecasting, more visibility, less duplication of data and fewer errors. While some conceded that other eClinical data, such as eCOA have not overlapped with IRT, better integration is future-state imperative (especially considering the rapid adoption of eCOA).   Looking to the future, Imran Shakur and Chad Sklodosky concluded that blockchain advancements require interoperability.
  • Increasing regulatory scrutiny. In his call to action to sponsors and vendors, Craig Mooney’s regulatory imperatives included:
    • the ability to produce on-demand human readable audit trail reports,
    • data review needs to be ongoing, vs. taking place after the study

Regulatory considerations were frequently cited as the drivers behind new technology exploration, especially for more complete audit trail reporting and the ability to provide more data transparency.

Lastly, I was pleased to see the thoughtful discussion on vendor-sponsor relationship building, the recognition of the long-term value of partnerships and suggestions for onboarding, operational standards effective governance. Overall, the industry is ready for change and IRT technology has to keep pace with the demands of next-generation clinical research.