The CNS Summit has become a bellwether event for clinical research innovation as sponsors, CROs, sites, tech providers, and others gather each year to discuss the latest applications across research, trial operations, and the patient experience. This year’s event was a gravitational force for change, with thoughtful updates on decentralized clinical trial (DCT) progress, novel ways to ensure equitable access for patients, and a challenge to attendees for “more action and less talk” on patient support and engagement. Several standout themes and take-away messages included:
The bridge between research and care: Patients are beginning to have more participation opportunities through primary care, retail pharmacies, and other community-based settings, but adoption is slow. Across all research stakeholders, we must collaborate to optimize the ecosystem comprised of both research and care. Ramita Tandon, Chief Clinical Trials Officer at Walgreens, reinforced the need for collaboration when emphasizing that retail pharmacies are not trying to take patients away from medical practices or healthcare organizations. I agree that apprehension to community collaboration is rooted in fear of competition, but if we start with what is best for the patient, the industry could offer more choices for them without the fear of how this will impact the bottom line for all players in the ecosystem.
The evolution of DCTs: The industry has learned a great deal since the pre-COVID days of DCT “1.0”. Much of the infrastructure was already developed but not understood or adopted. The accelerated pandemic-era accelerated adoption (referred to as DCT “2.0” in Saturday’s DCT Town Hall) led to a number of different — and clunky approaches. As we move into DCT “3.0,” adoption rates are dropping again due to lingering operational challenges and patient burdens. For participants, it has frequently become an additional technology burden that oftentimes erodes the benefit. Unintended consequences range from unexpected participation dropouts to data collection problems resulting in many decisions to drop DCT study arms from studies. There’s also growing recognition that DCTs as a term is a misnomer because sites remain central to the conduct of clinical trials. DCTs were originally designed to bring more inclusivity into trials for participants who could not travel to sites. For many sites, it has been misconstrued by many as a means to cut them out of the way. Medable CEO Michelle Longmire captured the current state of DCT evolution by stating that “DCT is not a change in technology but rather in methodology.” David Coman, CEO of Science 37, emphasized the increasing importance of optionality when commenting that DCTs drive inclusivity so participants have a choice to participate at the site, home, a doctor’s office, a pharmacy, etc. instead of a single option. A lingering challenge for sponsors, CROs, vendors, and sites is creating an operational model that efficiently integrates research stakeholders and balances what the patient truly wants and needs. As Ramita from Walgreens stated, sites will pursue the use of technology, but if it makes the life of their participants harder, they will walk away, as protecting their patients is a paramount goal. We all need to apply Ramita’s concept to what we choose to implement and how to do it.
Diversity and inclusion themes were again interwoven into many of the keynotes and spotlight sessions. Carol Ferguson of Organon and Bayer’s Imran Nasrullah, MS, JD, had a powerful conversation on why we must all invest more in #womenshealth. In spite of the advances in technology, data science, and applications of behavioral health in research, patient outreach and education engagement needs to be micro-targeted and culturally relevant. Medidata and Circuit Clinical held interesting panel discussions on ways to benchmark diversity progress. As an industry, we’re only beginning to make meaningful progress, but there’s so much potential to advance health equity through more inclusive research. For sponsors and CROs, site partnerships are an effective way to connect with local communities in authentic and impactful ways (Tune into a Dec 6 webinar for more discussion on this topic from Parexel, UCB, ACRO, and me).
Impact of recent legislation. Discussions among CRO and pharma leaders provided an interesting forum on the impact of the Inflation Reduction Act on clinical development activity. Reflecting on the increased cost of capital, Parexel CEO Jamie Macdonald suggested that oncology and rare disease pipelines may be most impacted if a disincentive to conduct additional research beyond an initial product materializes. Another biopharma executive predicted an increase in licensing activity, complementing existing biotech productivity. Industry insiders are united in the belief that this legislation will serve as a catalyst for much-needed standardization and more efficient clinical development operations. We’re also likely to see more research efforts at scale, from formal collaborations to the expansion of site networks where the benefits of centralization can be achieved.
While the CNS Summit discussions rarely disappoint, in future conferences, I’d like to hear more about how research stakeholders are collaborating earlier in clinical development and supporting sites in light of increased pipeline activity, study complexity, additional technology, and staff shortages. This is a growing challenge that demands novel solutions.
Author: Carlos E. Orantes, Chief Executive Officer