Last month, I had the great pleasure of attending the PhUSE US Connect 2018 conference in Raleigh, NC. It’s the first time the conference has been held in North America, and it was great to see new faces in the inaugural gathering of a US audience.
PhUSE is an organization that began as a European biostatistics user group and has since grown into an independent, not-for-profit organization with a global membership. It provides a platform for discussing topics related to the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals.
PhUSE has focused on actively engaging with its community, from the Accenture-sponsored Annual Connect conference in Europe and hosting of Single Day Events, to participating in the annual Computational Sciences Symposium and other Working Groups. To me, PhUSE is particularly important because it fosters open, non-competitive collaboration across healthcare and life sciences—much like our own Life Sciences Cloud Coalition.
At this year’s first US conference, a couple of things really stood out for me:
Regulator participation. The FDA had a strong presence at this year’s conference. Leading working groups and presenting on various topics, it’s clear that regulators have become involved in everything the industry is doing. I also noticed their enthusiasm for collaboration. This strikes me as particularly important because they can provide insight into what goes on inside the FDA when they receive submissions and, as we look at making changes to the way we operate or the technology we use, they can give us input, long before testing new initiatives during the submission phase.
The drive to achieve technology standards. This year there were many presentations on technology and technology standards—with a particular focus on minimizing duplication of data and the number of steps it takes to move through the clinical trials process. People are struggling to find suitable platforms or a way of working that suits all R&D stakeholders. What is needed is a single source of truth—perhaps even a single industry clinical trials database. Many are also in favour of providing regulator access to final study data to reduce the need for filing separate submissions—this would also give the regulators the exact same data in exactly the same view that the Pharma company uses—and vice versa!
The dialogue and ideas from the PhUSE US Connect fully align with the goals and vision we have for the Accenture Life Sciences Cloud (ALSC) for R&D platform, which we have designed to be a single repository of data for clinical trials, with visualizations of studies and analytics that can help the industry from research to commercial development. This supports our ultimate vision of providing access for regulators to view final study data, replacing the need for companies to file submissions separately.
During the conference, I was fortunate to be able to participate in the executive summit and see my colleague Jeff Elton present on the future of healthcare, exploring what healthcare will look like in the 2027/2028 timeframe. For many pharma companies, it was an eye-opening view of the things payers and providers are investing in, including:
The use of sensors and wearables
Different ways of conducting business that put the patient in control of their data
Because payers and providers are looking this far into the future and beyond, we cannot continue to use outdated technologies or ways of conducting research in the clinical trial space. We need to recognize how a trial can affect a patient’s regular standard of care if we expect to get the level of participation in clinical trials needed to be successful. Fortunately, Accenture can help bridge the gap between healthcare and life sciences, and bring real-world knowledge back to pharma.
My congratulations to the PhUSE organisers for a sold-out event and for bringing industry influencers and decision-makers together. I’m always impressed with how PhUSE organizes themselves and their loyal following, and this inaugural US event was no exception.