Clinical Operations Teams Prepare for the Future with Digital, Patient-Centric Trials
The move to patient-centric, paperless trials was the key theme for the more than 300 clinical operations professionals who gathered at the Veeva Europe 2021 R&D and Quality Summit Connect in mid-May. This year’s clinical operations track featured nine customer-led sessions in which industry experts shared their experiences, insights, and strategies to accelerate clinical research.
The consensus was clear: The industry cannot go back to the old way of doing things. “COVID forced us to use new approaches, and it would be hard to put the genie back in the bottle,” said Amy Kisken, senior director of study start-up and conduct specialists at Bayer, who shared best practices for trial startup and deployment, as well as key lessons learned during the pandemic.
Digital clinical trials
The clinical operations track kicked off with a discussion about the current and future state of the industry by clinical and IT leaders at Roche and TFS Health Sciences. Among the old approaches that must change, speakers agreed, is reliance on outdated, disconnected systems augmented by Microsoft SharePoint and Excel – and processes still requiring physical paper copies. “One question I often have when addressing end-user pain points is: ‘Why are they still using spreadsheets when we have much better tools now?’,” said Peter Bachmann, informatics business partner at Roche. “There is no place for paper anymore,” stated Ronel Steyn, vice president of Clinical Design Services at TFS Health Sciences.
Patients are also driving the move to more modern, digital approaches to clinical trial operations, said Bachmann. As they have become more familiar with new e-health applications, they have come to expect digital apps for clinical trials, he explained, noting that the pandemic created even greater urgency for clinical trials to become more virtual and deliver a safe, convenient patient experience.
Rethinking industry standards
On the technical level, cloud-based models are changing how companies view clinical data and offer them an opportunity to rethink industry standards, Bachmann said. “In the past, sponsors would think in silos, investing in best-in-class technology for each application, without providing much integration between apps. Software as a service changed this picture by integrating and unifying data and providing real-time access to actionable information, both internally and offsite,” he noted.
In the long term, the life sciences industry will need to standardize data and create a digital infrastructure for R&D, as the banking industry did when it enabled electronic transactions, both Steyn and Bachmann agreed. “We’ll need to work with CROs and partners to agree on the best designs, tools, processes, and to share information. Teamwork will be essential,” she said.
Sites and sponsors move to close partnerships
As clinical sites become more important to patient recruitment, sponsors and CROs are abandoning old transactional connections in favor of collaborative partnerships with sites. This trend will continue as therapies and trial designs become more complex and the field becomes more competitive, said Dan Milam, director of Clinical Trial Partnerships at EQRx, in a discussion of evolving site and sponsor relationships. “In the past, pharma companies used to simply dictate their protocols; now they realize that sites are the key to reaching and recruiting patients and making clinical trials more patient-centric and site-centric,” he said.
EQRx, which focuses on bringing therapies, primarily oncology drugs, to the market at radically lower prices, has set up a Strategic Master Site program, establishing close collaborations with key sites for the long haul, Milam explained. In this arrangement, EQRx educates site leadership on its pipeline strategy, overall mission, and how each trial fits into that bigger picture. In turn, the site communicates its needs, and both parties find better ways of working together. One important driver is preventing technology from becoming a burden to sites, Milam said. “SiteVault Free from Veeva is designed to do just that, giving clinical research sites a free, site-owned technology to manage their clinical operations and reduce administrative burden,” he adds.
Improving CRO connections
During the sessions, companies shared lessons they’ve learned and results they’ve seen as they move to unified, more streamlined approaches. In a panel discussion on TMF Transfer, Hélene Clavien, clinical research unit quality manager at Nestlé Research, discussed how the tool streamlines the transmission of documents between CROs and the company. In the past, the hundreds of thousands of documents required for a typical large Phase III study were sent by truck, and later via CDs and flash drives, posing significant data reconciliation and processing challenges. TMF Transfer allows TMF data to be sent directly in digital form from CRO to sponsor in a simple, four-step process.
Sharing best practices for ensuring inspection readiness, panelists Christine Bruun Sanders from Ferring, Marie-Line Laberge Morth from Ipsen, and Pawel Rucki from Base Life Science reviewed risk-based approaches that they take to ensure compliance and completeness of sponsors’ TMF documents. All three companies are using Vault eTMF.
Also sharing a mid-sized CRO’s perspective on change, Magdalena Matusiak, head of data science and document services at KCR, discussed results and best practices from the company’s modernization efforts. The company started with Veeva Vault eTMF in 2014 and continued with the implementation of Vault CTMS and Vault EDC along with other Vault applications. So far, streamlining its approach has enabled KCR to move away from having one manager responsible for all aspects of each trial to a structure in which local functional groups assume more responsibilities for relevant documentation. Since installing Vault eTMF, KCR found that the timeliness and completion of its TMF documentation nearly doubled between 2018 and 2021, with timeliness reaching 95% and completion, 96%, Matusiak said.
GSK consolidates gains; AstraZeneca reduces manual processes
On the sponsor side, Astrid Beriaux, director and head of clinical documentation at GSK, shared lessons learned and results achieved from her team’s implementation of Veeva Vault eTMF across vaccine, pharma, and consumer healthcare divisions. The process has improved alignment both internally, and with CROs and clinical research sites, she says. Astrid and her team developed a role-based training program and established an “ambassador network” to connect end-users to the project, share progress, and capture the voice of the customer.
Also offering insights from the sponsor’s point of view was Debbie Brook, head of global clinical solutions development operations at AstraZeneca’s R&D division, who detailed the company’s efforts to streamline clinical data management. This work began in 2015 with the rollout of Veeva Vault eTMF, and the company later added Vault CTMS and Vault Study Startup modules, which replaced 20-year-old technology, including Microsoft Excel spreadsheets and Word checklists.
The company’s latest Veeva Vault implementation went live in June 2020, Brook noted. So far, modernization has led to a 50% reduction in the time required to write monitor visit reports, saving 100,000 person-hours per year. It also saved 220,000 person-hours per year in the time required for data extraction and reporting. AstraZeneca has also reduced paper document scanning and distribution by 80%, Brook said.
Clinical trials look different post-COVID and are likely to look very different in the future, as the industry accelerates its use of digital technologies to speed clinical trials. Sean Connolly, head of R&D IT, and Anders Persson, transformation leader for digital health, R&D at AstraZeneca, discussed efforts underway to reduce drug development timeframes by 1.5 years.
The many sessions throughout the day reinforced how sustainable innovation is advancing the industry towards better ways of working. Modern cloud technology brings together sponsors, CROs, sites, and patients with a better experience and applications designed precisely for their needs – and enables patient-centric, paperless trials to speed clinical research.
A huge thank you to our many presenters and the 300+ attendees for their participation and knowledge-sharing. View key presentations on-demand from the 2021 Veeva R&D and Quality Summit Connect, Europe.