By: Kimberly Ray | February 03, 2017
Why targeted oncology research requires a more precise approach to clinical trial design.
World Cancer Day is fast approaching and there is a lot of reason to celebrate. Over the past few years, precision medicine has revolutionized cancer care, giving hope to millions of patients. Advances in immunotherapies, targeted therapies, and diagnostics are transforming the standard of care and significantly improving survival rates for these patients.
At the heart of many of these innovations is the ability to target niche patient populations with treatments designed to address a unique tumor type. It is an exciting step forward for patients and the biopharma industry, but it has also added an extra layer of complexity to the clinical research process – finding very specific patients.
Patient recruitment is already one of the most expensive and difficult-to-predict aspects of clinical research, and the highly targeted inclusion criteria for a precision treatment leads to a higher screen failure rate. Even the very best sites that have access to the right patient populations and the best tools and staff to drive recruitment, are sometimes not able to enroll because the inclusion criteria is so restrictive. According to a Tufts Center for the Study of Drug Development (CSDD) report 11 percent of sites in any given trial fail to enroll a single patient, and more than a third fail to meet their recruitment targets in the desired timeline. This is even more of a concern with precision medicine.
This high degree of failure demands a better approach — and at QuintilesIMS we’ve come up with one. Precision Enrollment shifts the recruiting paradigm by bringing the trial to wherever we find the patients, which will speed recruiting, lessen the time and cost of research and, most importantly, make trials more accessible to the patients most likely to benefit.
In a traditional trial, CROs and sponsors identify a limited number of trial sites, spend roughly 30,000 dollars to initiate each site, and then approximately $1,500 a month to maintain it in hopes that they will be able to recruit the necessary number of patients. This is a great model if a company is developing a treatment for a common ailment, like diabetes or heart disease, but it’s a shot in the dark in the field of precision oncology research, where targeted patient populations are small and scattered. Additionally, a recent study from MD Anderson Cancer Center showed that even when oncology patients were eligible for a genomically-matched clinical trial, only one-in-ten went on to participate. Many cited distance to the trial site or timing of participation as their reason for declining.
Precision Enrollment addresses these issues by turning the site selection process on its head. Rather than choosing a select few sites and investing heavily in their preparation, we’ve established a network of 135 investigative sites across the U.S., all experienced in oncology research and eager to work in this new paradigm. In the rapid enrollment model, a site is only opened after a patient is identified, which eliminates the risk of investing in facilities that won’t find participants, and it opens the trial to patients across the nation. This model also rapidly speeds start-up at the site. By using master contracts, a centralized IRB and aligned processes, every oncology site in the Precision Enrollment network can be up-and-running within 21 days. This is a significant improvement compared to the over 240 days (pre-study visit to site initiation), on average, that Tufts reported it takes to start-up a site in a traditional model.
This innovative approach benefits sponsors, sites, and patients—cutting time and cost from research, ensuring sites are successful, and enabling more patients the opportunity to participate in trials that could benefit them.
For this network to function optimally, we must move away from traditional thinking on how trial networks are established and how to contract with sites. While working in a new way can be tough for some, the potential savings, both in time and cost, make it worthwhile.
Precision medicine is the future of oncology research. To embrace this trend and bring leading-edge products to market, we must overcome the recruiting obstacles that stand in our way. We believe this enrollment model is an important tool in that effort.