Chief Operating Officer
January 24, 2023
Cohort management in early phase oncology trials can feel like a complicated dance. These trials enroll sick patients who are in the end stages of their disease or have experienced failures with other treatments. They often see early phase oncology trials for new therapies as a last hope. Many oncology patients point to the story of Emily Whitehead, a six year-old with acute lymphoblastic leukemia, who hadn’t responded to any chemotherapy treatments. Her parents were told the cancer was terminal, but they were able to enroll her into an early phase CAR-T cell therapy trial. The therapy had never been tested on children before. By her seventh birthday, she was completely cured.
Emily’s success highlights the amazing innovation occurring in oncology research today, and it gives cancer patients hope that a groundbreaking new therapy could be right around the corner.
It also makes opportunities to get into these early phase oncology trials so important to patients who have few other treatment options to pursue.
However, early phase oncology research is a unique environment. These phase I trials are designed to test varying dosages and treatment toxicity. To find the optimal dosage, sponsors will only recruit a few patients at a time to test each dose level before escalating to the next dose.
These early phase oncology trials often have short start-up timelines, and may have very specific inclusion / exclusion criteria, which puts pressure on study coordinators at the sites to find and vet patients as quickly as possible. At the same time those coordinators have to be sure that a spot is still available before promising it to a patient. If a sponsor is using multiple sites for the trial – and most of them will be – each site could be recruiting for the same opening at the same time.
The simultaneous pressure to find suitable patients, without giving them false hope of a trial that is already full, puts a strain on sites, patients and their caregivers.
5 elements of effective cohort management
To ease that pressure, Aperio works with sponsors to create a cohort management plan prior to the start of each early phase oncology trial. This plan ensures recruitment aligns with study parameters and establishes a flow of communication to keep all sites and study coordinators up-to-date on current enrollment.
To build that plan, we consider the following:
- Goals and Objectives. In order to successfully operationalize a trial, it’s critical that the CRO takes the time up front to establish a clear understanding of the sponsor’s objectives and goals for the trial. What trial design has the sponsor chosen (adaptive, 3+3 or rolling 6?) and why? Are there preferences for slot allocation, timing or the need to balance equitable assignment of spots (e.g., a ‘batter up’ approach versus competitive)? Does the sponsor have a specific site strategy, such as managing thought leader expectations and publication strategy? Are there drug supply limitations or other challenges the CRO needs to manage?
- Number of sites. As part of the planning process, sponsors and their CROs should determine how difficult the trial will be to recruit patients and how many sites will be required to meet their goals. This will be based on past experience recruiting the targeted patient population and intelligence on competing oncology trials recruiting from the same population. There should also be a strategy for layering in sites as the study transitions from escalation to expansion phase.
- Real-time updates. Every site should have access to real-time data about trial dates, number of open slots in the current cohort, number of sites recruiting and whether any patients are being considered for those openings. Information about trial recruiting can change daily, so having a real-time system of communication – regardless of time zones – will encourage sites to be aggressive in finding patients without fearing that they are making promises they can’t fulfill.
- A single point of contact. It’s a common misconception that a site can “hold” a spot in a trial for a potential patient they haven’t seen yet. This can create confusion if multiple sites each have promising candidates vying for a single trial opening. It may also cause sites to pre-emptively secure spots for patients who haven’t yet definitively met inclusion criteria, only to have them drop out when the data doesn’t match. Having a single point of contact who is always available, knows whether spots are still open, and has final say over who is accepted based on demonstrated patient data will reduce confusion and ensure only patients who qualify are confirmed.
- Accelerated data review. Prioritizing real-time data review in early phase oncology trials will speed understanding of the safety and efficacy of the current dose, which benefits current patients and gives site coordinators more time to find and vet participants for the next cohort, if one is needed. Prioritizing data collection and review is key to completing this critical phase of early research.
Many sponsors in the oncology space are working in emerging and mid-sized biotechs and may have little experience managing the complexities of enrollment in early phase oncology trials. Working with a partner, like Aperio, can help them implement best practices for cohort management and recruiting patients while making sure patients have the optimal opportunity of being accepted into an early phase oncology trial that could dramatically impact the rest of their lives.
In our next blog post, we will talk about how working with smaller, community-based sites can reap great dividends when conducting competitive oncology trials.
Want to learn more about Aperio’s expertise and approach to oncology trials? Contact us to speak with an Aperio expert today.