Mark Maietta, President and Chief Commercial Officer
Each day, 40,000 people worldwide are diagnosed with cancer. The current pipeline represents the greatest opportunity for cancer patients, but how can we do better as an industry in delivering breakthrough therapies, and how can we do it faster? How can we make trials not just acceptable to patients and sites, but easy and convenient? How do we prepare for the future? These were some of the questions raised at The Society for Clinical Research Sites (SCRS) 2nd annual Global Oncology Site Summit.
This two-day event explored the direction of oncology clinical research, the role of technology and innovation, and the best practices emerging from evolving cancer care delivery and treatment possibilities. Key themes and select highlights included:
Cancer Care and Clinical Trials are Rapidly Changing
Oncology clinical research of 2020 looks nothing like it did 10-15 years ago. In the last 20 years, cancer care has moved from the blunt instrument approach of surgery, radiation and chemotherapy to targeted and immunotherapies, which now represent 90% of the oncology pipeline.
Master/umbrella trials offer significant benefits to patients, with the increased probability of inclusion in a trial targeted to their mutation as the most important. As many as 30 studies or more may be included in a master protocol. They also offer the ability for researchers to gather immense data across a patient population.
Drugs are approved faster, as early phase studies are now registrational. In 2018 alone, 12 drugs were approved based on a single study.
Changes to drugs and study designs are driving record number of approvals. If 2014 was a watershed moment with the first PD-1 checkpoint inhibitor approval, the floodgates opened soon after. The past five years have seen an unprecedented accelerated pace in the number of new oncology drugs entering the market.
Technology and Innovation
The role of technology is central to the future of oncology research to ease the burden on sites, speed execution and make it easier for patients to participate in clinical trials by improving recruitment, retention and participant diversity. Technology, if designed and implemented thoughtfully, can drastically reduce the amount of time that site staff spend on redundant activities. Breakout discussion supported more data standardization in start-up activities and the use of a shared investigator platform. As one example, current trials supported by the Leukemia and Lymphoma Society rely on an embedded pipe from EMR to EDC systems, and are rapidly moving away from all manual data transcription.
Trial complexity – in the form of multiple endpoints, increased eligibility criteria, more systems and specialized procedures, among many other criteria – continue to place an undue burden on site staff.
The rise of precision medicine and companion diagnostics make it harder to recruit patients. Sites must be more strategic at reaching patients at the right path in their journey, employing a mix of digital outreach, physician referral efforts and patient-friendly communications.
Site representatives’ voices were united in their desire to reduce time spent on perfunctory activities to allow more time to focus on patient care. Two key challenges involved the amount of systems needed to support a single study and integration into the workflow.
- System fatigue was a commonly-expressed sentiment. It’s not unusual for a single study to involve nearly a dozen systems and for a coordinator to manage up to 20 studies concurrently. What’s more, the systems are archaic and lack interoperability, which requires an estimated 40% more time from site staff for double data entry, ongoing training for multiple system requirements and login credential management.
- 60% of coordination time is spend on regulatory documentation.
With the increased volumes of data, the acceptance of risk-based and flexible monitoring approaches help sites focus on the issues that are critical to patient safety and regulatory submission.
Virtual or decentralized trials are a core component of SCRS’ digital innovation initiative. On the surface, decentralized trials may not seem like a perfect fit for the hands-on nature of oncology research, but interest is thriving, and there are scores of operational models flexible enough to meet the needs of today’s cancer patient. Virtual trials also help address the dearth of diversity in participation by removing transportation barriers. Models involve a mix of telemedicine or home health visits from nurses and phlebotomists to offset the need for frequent clinic visits, and as an incentive to participate in an otherwise burdensome study. The use of central pharmacy, remote biometric data collection and home devices are common operational elements of these trials.
Important Gaps to Fill: Patient and Site Voices
Breakout discussion constructively addressed continuous improvement in patient awareness, trial access and technology solutions.
Awareness and Access: Trials should always be discussed as a care option. As treatment evolves, it’s important to bring research into early discussions of patient care, to expand awareness of all treatment options and available clinical trials. This also brings more research into early stage disease, instead of resorting to clinical trials as a last hope. While patients who begin treatment on a clinical trial can move to other treatments later, the inverse scenario is not always the case, due to restrictive eligibility criteria.
Patient Convenience: As a research community, we must continue working to make trials easy and enjoyable for patients to participate. Survey data revealed that most patients surveyed want to participate in research, but conditions of eligibility are often too restrictive, or they are unaware or where to look or whom to ask. 30% more patients are willing to participate in mobile vs. traditional trials. Patients are also willing to use all types of data collection from mobile apps to bodily fluid diagnostic devices, but not in the absence of face-to-face interactions with care delivery teams. Breakout discussion focused on how to balance high tech with high touch solutions to offer more face time in patient care. One example focused on virtual trials suggested allowing patients determine which visits should be remote vs. in-clinic. Other examples emphasized the need for information-sharing on trial progress and results.
Technology Solutions are acknowledged as well-intentioned by site representatives but often miss the mark and have the opposite effect. This was discussed at length during many of the breakout sessions. Len Rosenburg of the Leukemia and Lymphoma Society advised technology providers to take the time to integrate technology (vs. overlay) technology into existing workflows, and take the time to understand the patient pathway before deconstructing the workflow. There’s a common perception that many technology providers don’t consider where a given solution fits into the overall workflow and interacts with other systems.
A key takeaway for technology providers was the reminder to work with sites during the design stage. For example, it’s practical to allow sites the use of some of the traditional workflow elements to which they are accustomed while introducing new technology is important, so staff aren’t forced to radically change processes and behavior while piloting new solutions.
Technology is critical to support the complexities of stratification, umbrella trials and virtual trials but early involvement and education with sites is essential to success. A site representative offered the example of eConsent. She explained that some site staff felt threatened by their perception of its functionality – as a replacement instead of a complement to start-up tasks. In parallel, many of the same perceptions are evident with the adoption of AI. Engagement on the front end and follow through brings value to everyone in the ecosystem was the consensus of a discussion on Site Innovations with Transformation Digital Technologies.
Measures that Matter: Dr. Deborah Patt, MD, PhD, MPH, MBA, FASCO concluded her discussion on Paradigm Shifts in Cancer Care by expressing excitement for progress in adoption of ePRO/eCOA with wearable and sensors. She referenced the work of Dr. Ethan Basch of the UNC Gillings School of Public Health who concluded that PROs in the care delivery kept patients on treatment longer, and contributed to improved outcomes.
Wrapping up in time for the Super Bowl (Go Chiefs!), this productive weekend meeting served as a call to action for sponsors, investigators, academia and service providers, reinforcing that great work is taking place, with a bright future but we have a lot of work to do as a research community.