A Great Leadership Event for Exploring New Models and Maximizing Value for Clinical Research, Innovation & Digital Health
At SCOPE 2021, the focus was on data for actionable insight, not after-the-fact support. Let Adaptive Clinical Systems help you aggregate and integrate your clinical trial data with Adaptive DataVIEW™ and the Adaptive eClinical Bus.
Wow! – what an inspiring start to the SCDM Live Global Conference! Some 1,500 data professionals around the world joined to share clinical data management experiences and insights after a year of accelerated, COVID-driven change. There were a number of excellent presentations on AI/ML.
Chris Lintott, Professor of Astrophysics, University of Oxford and Sanjay Bhardwaj, Executive Director and Global Head Clinical Technology Strategy & Operations, AbbVie, delivered a fascinating Keynote titled, “The Next Big Step – The Future for Clinical Data.”
The age of big data is here, and drug development is filled with new possibilities. In a positive and refreshing perspective, Chris and Sanjay look to a future with powerful opportunities in which AI/ML works in tandem with human knowledge and intuition.
Other highlights of the conference included these industry changes due to COVID-19:
► The patient has become the focal point for clinical trials going forward. De- centralization and virtual execution will bring studies to the patient in the healthcare ecosphere where the patient lives. Protocol design includes serious consideration to managing if not reducing patient burden.
► Innovation in eClintech and eSource will continue at a rapid pace. The plethora of patient devices brought on by the COVID pandemic has merely scratched the surface of its potential. The emerging inclusion of RWE data will transform both the design and conduct of clinical trials.
► Change is hard and the innovation we’ve experienced this past year still has significant challenges. Decentralization introduces a new set of complexities for integrating, transforming, and operationalizing data that must be addressed for true data interoperability to deliver on its potential.
► Skepticism for continued industry collaboration all but suggests industry will revert to pre-pandemic competitive behaviors. Regulatory acceptance of novel solutions is now established due to the pandemic. Companies are likely to leverage this individually for competitive advantage.
Keeping Momentum in Innovation
The conference kicked off with an amazing plenary session discussion, “Accelerated Drug Development in Response to the Pandemic: Lessons Learned and Key Drivers.” Leonard Sacks, FDA CDER, and Kenneth Getz, Tufts University, discussed how collaboration is expanding with more stakeholders willing to adapt and collaborate including between industry and regulatory. New models were embraced including virtual, remote data capture, and more frequent data capture. The FDA is supportive of decentralized trials (DCT), and more DCT will be applied in the future. Patients being able to provide data from or near their homes and not having to rely on sites may have a lasting impact. This may be a driving force for the industry to change when it has been hesitant to in the past. Panelists cited: better recruitment, and better reach to under-represented groups.
Changes in 2020:
► Stakeholders were more willing to adapt and collaborate; “level of collaboration we have not seen”
► The collaboration included industry participants and regulatory authorities
► New models have been embraced: virtual, remote data capture, more frequent data capture
Will the changes stick?
► Not certain; the industry is complex and change is not easy. Development programs are ever-more complex
► Will require a fundamental re-look due to the industries hesitancy to change
► Patients being able to provide data from or near their homes and not having to rely on sites may have a lasting impact. Better recruitment, better able to reach under-represented groups
► The FDA is supportive of decentralized trials. DCT is likely to be broadly applied in the future
New Models Driving Digital Innovation
Several sessions over the course of the conference focused on digital health and eSource. We found great opportunities and insights for new uses of data.
In a presentation “Digital Health Technologies – Maximizing the Value in Clinical Trials,” Marie McCarthy of ICON stressed that consumer consumption trends provide an opportunity for clinical trials. The growth in digital adoption among adults has exploded.
Some promising metrics:
► 3.5B smartphones world-wide
► 21% of US Adults have a smartwatch or a fitness trackers
► Monitoring device adoption grew from 17% in 2015 to 24% 2017
► US telehealth visits grew from 11% of visits in 2019 to 46% last year
The potential and promise of digital applications are extremely enticing:?
► Passively capture clinically meaningful data in the “wild”
► Obtain both Subjective health and quality data PLUS Objective data
► Added and significant ability to do active outreach
However, McCarthy also cautioned that clinical trials remain a scientific endeavor and many concerns exist regarding new devices and associated data.
Consider the device:
► Privacy requirements
► Device quality and capabilities
► User Experience
►Validation to protocol
► Vendor experience
► Data verification
► Interest and engagement
And then the data itself:
► Missing data
► Source data verification
► Data capture
► Noise and user training
► Quality content
► Sustained engagement
Adaptive Clinical Systems participants really enjoyed the session led by Michelle Yu, MS, Associate Director Total Feasibility Services, WCG, titled “A Perspective on Data-Driven Study Planning: Letting the Numbers do the Work”. Her session was right up our alley and we appreciated her focus on using Use data for actionable insight, not for after-the-fact support.
Many of her examples focused on the three key steps for gaining more data insight — aggregate the data, integrate it, and curate it.
Adaptive Clinical Systems felt an affinity with this session. For more than a decade, our focus has been to improve interoperability for our users.
Digitalized Clinical Development Requires Next Generation Technology?
This session, led by Jason Housley, Global Head Data Standards and Automation, Novartis, and Berrie Nelson, Vice President Digital Clinical Innovation and CSO, Nurocor, focused on the desired business outcome rather than the technology. The presenters expressed concern that technology has not brought the desired efficiencies. Clinical development is still very much a siloed process. Industry is still doing things how we did them before – in a linear fashion with no meaningful transformation. And the presenters questioned, Why? They postulated that two groups are separated by an impenetrable brick wall: The metadata experts are on one side, who know everything about the data. On the other side, the CDR systems, programmers, data managers are on the opposite side. The industry has not figured out “how to move from the left to the right.”
The session leaders propose that a digital platform can enable the common language. This is not just a product solution; and it must involve people, product, and process. This team has found that digital brings significant time savings, “31 1/2 weeks shaved off startup and close out. The actual trial itself will still take time.”
Adaptive Clinical Systems agrees that there are many best of breed solutions that are great technologies. They all don’t necessarily share data or common data sets. Interoperability is where we help break down silos. See our video here for more information.he considerations for the devices themselves as well as EDC systems to support them.
Moving toward Platform Thinking: Creating a More Seamless Front-End and Back-End to Future-Proof and Advance Digital Transformation in Pharma
Thought leaders Adama Ibrahim, Hassan Kadhim, Craig Lipset, Disa Lee Choun, and Mohammed Ali shared keen insights on where we should point our industry. In this session, the panelists noted that COVID has been a reality check for the biopharma industry, and it is evident we should be focused on future proofing. We operate through webs of legacy systems, complex org charts and entrenched “resistance to change” cultures. Platform thinking is the opposite. Imagine a patient or physician able to find, learn about and participate in clinical research like the way we all interact with our own shopping services through apps and sophisticated yet simple technology solutions.
Some interesting takeaways for a better drug development future:
► Create a large, comprehensive registry connecting patients with all clinical development stakeholders – access more, more quickly
► Develop a common validation methodology across diseases – increase pre-competitive sharing
► Utilize technology for aftercare – maintain continuity of care whilst co-purposing data for current development
► Un-fragment the patient experience – streamline access to research as a part of continuous health care in daily life
We found some consistent themes during SCOPE2021! Adaptive Clinical was excited to be a part of the conversation, and we look forward to discussing more trends in our next blog!
About Adaptive Clinical