The combination of ever more personalized medicine as well as complex adaptive study designs means that oncology developers can now run successful clinical trials with smaller, more targeted subsets of patients. However, with the benefits, personalization and adaptive design also bring new challenges, with greater competition for patient access and increased complexity for sites. Matching the right sites to the right trials is therefore more important than ever for oncology trials.
This is where the Oncology Site Network for Precision Oncology comes in. Established by Dr Tandy Tipps, the network is focused on optimizing study start-up at both academic and community-based sites across North America and Europe. With 25-years’ experience in biotech, pharma, CROs and healthcare, Dr Tipps took the role of Vice President of the Precision Oncology Site Network having previously overseen the world’s largest phase 1 program for cancer research and treatment at the MD Anderson Cancer Center.
In this exclusive interview, we asked her about the critical factors and strategies for choosing the right site and how that decision can help reduce trial risk and expedite study start up.
How are oncology clinical trials changing due to advancements in personalized medicine and complex adaptive study designs?
TT: 'Individual, personalized, and patient-centric medicine represents the future of oncology research. This means we could be targeting quite small and highly defined patient populations. We need to be sure to recruit sites with timely access to these patient populations in order to achieve enrollment success.
When we recruit for our trials, we know it is important to identify sites that have a commitment to personalized medicine and are practiced at conducting potentially complicated sample collection that could involve blood or tissue or both. Sites are energized by targeted study designs because they can offer a clear advantage to a defined subset of patients.
As targeted therapies that are highly successful become more prevalent, patients will have a greater incentive to participate in clinical trials that are specific to them. We are also aware that, although the site may be highly experienced, the staff within the site can vary in its knowledge and skill sets. Our teams are practiced at developing tools and training as part of our standard site support, to help ensure things are done consistently across all centers.'
What is the role of the Oncology Site Network for Precision Oncology and how is it helping tackle these challenges?
TT: 'Our entire focus is on personalized approaches to the treatment of cancer. Not every site is skilled at conducting this type of trial—it can be complex and challenging. We found we kept going back to the same core group of sites to conduct key trials and decided to formalize this core into the global Precision Oncology Site Network.
Our highly skilled sites are experienced in working with novel compounds, understand complicated sample collection requirements both in tissue and in blood, and have broad access to patients across every tumor type. With over 50 current sites and pending expansion into the Asia-Pac region, this network allows us to have ready access to appropriate sites to facilitate feasibility and selection as well as a consistent and predictable study start-up time frame.
Additionally, our network sites have established a precedent of performance both in enrollment and in data quality that reduces execution risk. Challenges are further mitigated as a result of network sites being selected with an emphasis on geographic expanse and diversity in order to provide novel therapies to patient populations that might otherwise not have such treatment options.'
How can you reduce trial risk by working with the right sites?
TT: 'Risks are mitigated and reduced by knowing the strengths and weaknesses of each respective site and ensuring there is a match between site capabilities and interests with the goals and needs of the sponsor and the protocol. High familiarity, strong relationships, and proven performance in similar trials help reduce risk of failure.
What are the main challenges with study start-up for complex oncology trials?
TT: 'Oncology clinical trials involving targeted agents and other compounds either as monotherapies or in combination with other agents are of high interest. The number of skilled research centers capable of conducting complex trials with access to a broad number of patients is limited. Therefore, there is an increasing issue with the number of competing clinical trials at the major academic centers in the United States and in Europe. Careful evaluation of competing populations must be conducted with each opportunity, and broader geographic reach may be required to access appropriate patient populations for enrollment.'
How can study start-up for these complex, targeted oncology trials be expedited?
TT: 'Ready access to skilled oncology research centers for robust feasibility is essential to expedited start-up. Sites must be evaluated not only for patient access but also for staff availability to ensure facile processing of start-up documents. Profiling the start-up process and prequalifying critical “go-to” sites that routinely perform well in a broad number of trials will help facilitate start-up. Establishing relationships in advance allows for standardized general content for contracts, budgets, and regulatory requirements to be generated and serves as a baseline for swift study-specific adaptation. Strong site relationships that are built on repeat work and a basis of trust and transparency will differentiate performance and commitment.'