From February 12th to the 15th, more than 1,500 industry professionals from all over the country and the world gathered in Orlando, Florida, to attend this year’s Summit for Clinical Ops Executives (SCOPE). Leaders from pharma, biotech, clinical research organizations (CROs) and technology partners joined together to discuss the most pressing topics impacting the current state of clinical development.
There were a few common themes that kept bubbling to the top throughout the various sessions. These included: innovation, patient centricity, real world data/real world evidence, wearable devices/mHealth, Blockchain, and AI/machine learning. The common denominator across all of these increasingly relevant topics was the challenge of how to incorporate each piece into the context of the clinical development lifecycle. In fact, the SCOPE conference structure was organized around tracks that reflected the lifecycle, and these topics were “sprinkled” in that context among those tracks.
Wearable Devices, the Ever-Growing Technology Category
It was interesting to hear the pros and cons of incorporating, wearable devices -- a prevalent theme across many tracks -- into trials and their impact on the patient, investigator sites, sponsor/ CROs, and the trial itself. On the positive side, wearable devices provide a wealth of patient data and provide a convenient way for patients to participate in a trial. But on the other hand, they introduce a new set of challenges including:
The discussions showed that this is the direction clinical trials are moving. However, it was also noted that devices alone won’t be the future of clinical development. Devices will be used in addition to traditional methods of patient data collection and will provide additional, valuable insight.
Real World Data and Real World Evidence
In addition to the increasing volume of data from mHealth devices, there was significant discussion around the incorporation of real world evidence and real world data into the clinical development process, and how these additional data streams can help facilitate the advanced use of AI and machine learning in the clinical trial lifecycle. It’s an exciting time because there is now enough data out there to leverage this type of technology. But, there are still questions around how to incorporate real world evidence/data into the trial process. As the convergence of clinical and real world data becomes more of a reality, AI and machine learning will take on a bigger role.
At the core of most discussions was the vital importance of patient centricity. As technology advances, data sources grow, and processes change, ensuring that the human element of the clinical trial process is preserved. This perspective rang loud and clear. During one session, there was a discussion about not just using technology for its own sake (i.e. mobile devices and mHealth devices), but that the patient experience must be considered before adopting new technologies too quickly. Admittedly, some sponsor company representatives said they were quick to use mobile devices before thinking about the patient/user experience and that adoption of the devices was low or that patients opted out of their use. The bottom line was clear. The patient must be at the center of the plan, and technology is only great, if it is used.
The Blockchain topic was also related directly to the patient centricity theme. What if patients can collect their own EMR & EHR data from their healthcare providers? In essence, the patient would be curating his/her own healthcare data (see February 2018 Life Sciences newsletter for Apple Health App). Then they would opt-in to a clinical research Blockchain in which their data would be pushed and de-identified. The research community s managing that Blockchain, would perform many types of analysis against all the patients in that Blockchain.
Analyses such as: protocol feasibility, patient recruitment, outcome for payer reimbursement, needs assessments, and many other real world data use cases can be driven successfully from such a treasure trove. A key question is, why would patients opt-in to the Blockchain? While there are many motivational approaches, at the core it will likely involve some type of payment.
What if a patient could submit his/her healthcare data, and the data could be analyzed for its “value” to the clinical research consortium before the patient commits? What if the amount a patient will be paid could be a function of his/her agreement to provide the data over various periods of time? There are many interesting approaches that can be taken here. Something to remember is that the average cost of recruiting a patient for a Phase 2 or 3 Clinical Trial is approximately $40,000. So, there is money out there that can be used to motivate participation.
Scope 2018, a Great Platform for Learning
There are very exciting things happening across the clinical development lifecycle, and the future holds the possibility of bringing life-changing drugs/devices to market faster and more effectively. But, with these exciting developments comes some very difficult challenges to overcome.
The good news is that the industry leverages events like SCOPE to share ideas, best practices, key learnings, and thoughts on the future of clinical development. As a result, everyone benefits from these valuable discussions.
Overall, Scope 2018 enabled some very dynamic and interesting discussions. The entire Oracle Life Sciences team looks forward to seeing what the future holds at next year’s conference.
Greg Jones is Enterprise Strategy Architect, Life Sciences, for Oracle Health Sciences.