Clinical trial complexity and demands are rising exponentially for sponsors. Contract research organizations (CROs) also feel the pressure to get clinical trials completed in record time, and as efficiently as possible.
During my years working at CROs, what kept me up at night was trying to identify solutions for issues such as rising costs, process inefficiencies, unrealistic protocol development, and complex patient recruiting requirements, to name a few. After living with these pressures on a daily basis, I found two lessons that led directly to successful clinical trial implementations:
1. The sponsor/CRO relationship must be a strategic, collaborative partnership rather than a transactional, “client vs. vendor” affiliation.
2. The core value of putting “patients over process” must rule the day. This is vital to migrating efforts toward patient-centric drug development.
1. A Focus On Strategic Partnership
Around 70 percent of the time, sponsors complete a protocol for an investigational new drug and then give it to a CRO to implement. In this scenario, the CRO does not have a seat at the table to help develop and discuss the protocol, nor shape it in a way that could make it easier to implement. When a CRO is brought in during the protocol’s development, however, there is time to examine it and find ways to make processes more efficient.
CRO input is valuable at all stages during the life cycle of development from protocol design through study execution, supporting regulatory discussions and decision making, and even commercialization planning. Discussing findings and data milestones can help clarify what decisions need to be made and when.
Partnerships are not formed without give and take. To be at the table and invested in the process, CROs and CRO consultants need to commit to risk sharing arrangements, so they demonstrate they have a stake in the outcome, whether it is patient recruitment, retention goals, or site identification measures.
2. “Patients Over Process” = Patient-Centric Drug Development
Begin with the end in mind. Start with the question, “How do we get the right patients identified, enrolled, and retained for our study?” This approach puts protocol feasibility front and center. When you begin with the patient in mind, you design a protocol that fills a patient need. An example from oncology involves the development of oral therapies for metastatic breast cancer (MBC). A 2011 study notes that oral therapies offer benefits in terms of patient convenience, ease of use, improved quality of life.
A large part of this approach can begin with finding concentrations of patients to populate your study. When you consider that CROs must work to identify 10 patients to randomize just one patient to a trial, the value of technology is evident as it can automate the process of finding the right patients and reduce the screening process.
The proper approach also includes identifying the right sites near those patients. Consider the average cost is $20,000 per site to identify, start up, and communicate with a site during a trial. Another interesting statistic: 20 percent of sites do not enroll any patients. For a study with 100 sites, this can be a $400,000 lost. For larger studies, with 300 sites, you are spending $1.2 million with no useful endpoint.
Inteliquet supports both site feasibility/selection and patient recruitment efforts, so we help CROs provide data and insight. Sponsors see the CRO’s strategic value as a partner that addresses efficiency and cost challenges relating to reliable clinical research site selection. This includes technology to predictably identify high-potential recruitment sites and automated profiling of clinical research sites that benefit from opening a trial for specific diseases. We also optimize inclusion/exclusion criteria to assess possible patients on a per-indication basis. Such efforts reduce mistakes that can lead to poor site selection choices.
Yes, we have the technology to help CROs, clinical consultants, and providers collaborate to successfully enroll patients. Yes, we use real-world data to improve clinical trial design, drive clinical decision support, and control the cost of care. Our approach is to improve the quality of, and access to, more and better clinical trials for all patients.
Because, at the end of the day, it’s all about the patients.
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