Bryan Clayton, Vice President, Strategic Solutions
As a veteran attendee of Arena events for clinical outsourcing and clinical supply management, I always look forward to the variety of topics and perspectives offered at these conferences. Taking in presentations, round tables and panel talks, conference discussion at OCT New England reinforced that the road to new clinical research innovation is still paved with a “crawl/walk/run” approach.
Giovanni Abbadessa, Head of Isatuximab Non Myeloma Development at Sanofi provided a backdrop for this theme in his informative case study, Predicting Immuno-oncology (IO) Efficiency. He reminded the audience about the utility of incremental innovation when describing the progress of precision medicine. Using comparisons to the history of chemotherapy, and parallels with new technology adoption, Giovanni charted incremental achievements of industry efforts to advance response prediction and study design optimization. The takeaway? While significant work remains, precision medicine is moving at a much faster rate than chemotherapy, which took 45 years of experimentation before its use in clinical settings.
Ken Getz of the Tufts Center for the Study of Drug Development presented findings from the latest research on sponsor outsourcing practices, and how most companies approach outsourcing. With a firehose of information to digest, the following trends stood out:
- The contracting segment overtook other areas of clinical development, driven by healthy pipeline growth. (Infrastructure and staff and investigator site services comprised the other segments.)
- The use of outsourcing models doesn’t differ significantly from five years ago. Sponsors tend to employ a mix of models, ranging from transactional (to supplement capacity) full service (involving multiple clinical services, such as monitoring, project management, data management, biostatistics and medical writing) and functional service providers (focused on the provision of one functional area, such as clinical monitoring or data management).
- Of the three most commonly-used models, full-service remains the most popular.
- Outsourcing performance satisfaction yielded mixed results. Overall, sponsors cited satisfaction with accuracy and completion, but not so much with cost and cycle time expectations.
Other survey insights suggested there’s plenty of opportunity for outsourcing practices to evolve:
- KPIs often measure areas outside of CRO control, and most companies are not working with metrics developed collaboratively with partners.
- Optimal communication and governance remain a perennial challenge; with ambiguity around escalation and integration communication coordination.
- Relationship oversight tends to focus on compliance and risk mitigation. This focus, and the associated challenges are tactical in nature, suggesting that strategically-focused outsourcing is still more of an intent than reality.
Future areas of research to look for from Tufts include best practices for operational efficiencies and vendor qualification.
Within the Clinical Trial Technology and Innovation stream, we heard from Adrian Orr of Anika Therapeutics and Matthew Kratz of UBC about effective digital patient recruitment strategies. Again, there were no “magic bullet” revelations, as patient recruitment is arguably still the biggest bottleneck to successful clinical trials. Both presenters offered considerations on optimal channel use, and concluded that in spite of micro-targeting precision, significant cost advantages and flexibility when compared to traditional media, digital patient recruitment works best as part of an integrated, holistic approach.
The culture of clinical research continues to shift to the needs of the patient, albeit slowly. On this theme, Beth Zaharoff offered insights how to involve patients in early drug development, using Tesoro’s oncology program as a use case. Working with advocacy groups, patient feedback was used to inform:
- Recruitment barriers, protocol feasibility (acceptability of procedures, frequency and duration of visit schedules)
- Potential areas of additional support, (education, adherence or transportation)
- Participation concerns (risk v. benefit)
- ICF clarity (ease of comprehension)
Beth’s advice for managing expectations involved setting clear guidance for review, as well as prompt replies to questions, and detailed explanation about why certain protocol elements can’t be changed, while others can. Importantly, this presentation suggested that basic communication principles can go along way in building relationships and trust with patient groups.
Direct-to-patient and comparator trials featured in Michelle Novak’s discussion of novel clinical supply approaches. Representing Rx Solutions, she summarized a new clinical supply model that uses pharmacy cards to provide unblinded and commercially available product, procured through a pharmacy network. As a replacement for traditional reimbursement models and bulk purchases, key benefits of this approach (according to Michelle) are nearly zero waste.
GCP inspection readiness is a topic of nearly all clinical technology forums, and for good reason, as global regulatory scrutiny continues to rise with accelerated adoption of eClinical technologies. Kevin Anderson of Alexion offered perspectives for common themes and areas of divergence across FDA, MHRA and EMA priority areas, offering flashes of useful insights such as the European regulatory focus on process, compared with a US focus on study level detail. Using eTMF as an example, he advised the audience to pay greater attention to documentation, story boards to describe how a study was conducted, (and more importantly, how big-ticket issues were resolved) and sponsor inspection preparation. As a best practice, teams need to be well versed in describing how a process was followed, and be prepared to show evidence of ostensibly mundane tasks, such as document review and training.
Round table discussions closed out the conference. Rinaldo Dorman of Shire, who led the future technology assessment discussion offered welcome news to providers when stating that when evaluating clinical technologies, cost savings should be secondary. As a clinical procurement lead, Rinaldo’s priority is to find technology solutions that allow the company to get more out of their clinical investment. Discussion topics within this group included a range of topics, including the complement of wearables with ePRO assessments, BYOD, cloud-based procurement, an digital protocol platform for sites that contains an instant searchable engine. While discussion centered on the time-saving benefits of new technology, the group conceded that meaningful data on these time-intensive tasks is largely absent but needed for future technology assessments.
The overall conference takeaway? Clinical research and outsourcing look poised to remain alive and well for the foreseeable future, with plenty of opportunities for incremental and disruptive innovation.