Streamline Study Startup with Improved Site Selection & Feasibility
Site selection for clinical trials is often one of the biggest headaches for pharmaceutical sponsors and contract research organizations (CROs). Even with enough due diligence, activated sites can still fail to recruit the desired number of study participants. Reliable industry estimates peg the cost of these under-accruing sites to the pharmaceutical industry at between $600,000 to eight million dollars per day of trial delay. Besides the cost to sponsors, with new therapies taking between 10 – 15 years to reach patients, aligning with the top-performing sites is critical to minimizing this agonizingly long cycle time.
Identifying the top-performing sites for a study is essential to success. Sponsors and CROs may benefit from evaluating their current site selection and trial feasibility practices, and question whether they are resulting in optimal alignment with productive sites or could stand to be enhanced.
The Current State of Trial Opportunity and Selection (2022)
Using Better Data to Identify the Right Sites
Identifying the most appropriate and efficient sites is crucial and can prove to be a daunting task. Even if you manage to identify the perfect sites on paper, they may still struggle with a study due to staffing issues, limited resources, the protocol’s complexity, or a myriad of other factors resulting in subpar enrollment performance. Adding to this challenge is the likelihood of therapeutic and physical capabilities or facilities changing. Trial site organizations – like any business – want to continuously improve and update their facilities and expand their therapeutic capabilities to be able to manage trials across more indications and conditions.
Additionally, there are market forces at play, reshaping site-level organizations in the U.S. and globally – making it even more imperative for sponsors and CROs to possess the ability to have the most current data on site capabilities. Specifically, site sector consolidation largely fueled by private equity is resulting in the expansion of wholly owned site networks and integrated research organizations (IRO). Single investigative sites and smaller multi-center organizations are being acquired and merged into larger enterprises. As a result, a research site organization scaling through acquisition may not have say, a pediatric research capability today but, if they are acquired by an IRO or site network with that expertise, they might tomorrow.
By the same token, across Europe, the Middle East, Africa, and Asia in particular, the site landscape is dominated by site management organizations (SMOs), which sponsors and CROs are dependent upon and must funnel their new clinical trial opportunities through to access capable investigative sites across the globe. Those SMOs are constantly expanding and changing, adding sites and investigators with new and varied therapeutic capabilities given pharmaceutical sponsor pipeline migrations towards oncology and rare diseases, especially of late. At the same time, the “one and done” new investigator who does not continue to engage in clinical trials beyond an initial study, plus simply the low survival rate of smaller research sites just like any small business, means the trial sites each SMO can access on behalf of sponsors and CROs is always changing and evolving.
It is certainly not possible to mitigate all of the risk inherent in site selection. However, as in business and in life, past performance can often be indicative of future outcomes. Therefore, in the business of clinical trials, an examination of historic research site performance metrics data is an excellent starting point for sponsors and CROs to make more informed decisions on which sites have the capabilities to achieve success with a clinical trial.
Access to historic and current site performance metrics trends drastically improves decision-making, allowing teams to narrow in on potential risks and hurdles sites and study teams may face. Instead of relying on assumptions or potentially over-inflated, hard-to-validate site feasibility survey responses, the research operations professionals responsible for site selection or trial delivery and execution can access reliable, tangible site performance metrics. Research professionals and executives can make more informed decisions when selecting sites for a particular study by leveraging key performance indicators such as:
- Startup cycle times (aka “turnaround times”)
- Screening and enrollment performance
- Therapeutic expertise
- Physical site capabilities
- Patient recruitment techniques
- Protocol adherence
Collectively, study-critical information which could be stored and then called up and viewed as a type of site scorecard would help in assessing potential sites in the protocol-development stage, well before the formal trial feasibility process even kicks off.
Managing all this disparate site performance metrics data is clearly a challenge. If the sheer volume of data were not enough, a trove of site performance and capabilities data is often siloed in disparate systems and locations. A data-driven software as a service (SaaS) platform like Devana Solutions’ PROPEL technology acting as a centralized datahub when seamlessly integrated with other key components of a research organization’s technology stack such as Advarra’s Clinical Conductor clinical trial management system (CTMS) can help a research organization do the heavy lifting when it comes to storing, accessing, and displaying critical data to report and analyze site capabilities and performance metrics. Integrated, complimentary systems such as the PROPEL – Clinical Conductor CTMS combination allow clinical research operations professionals to capture, analyze, and share actionable data across their network or institutional footprint, including with decentralized site-based clinicians and study teams.
Clinical trial protocols are only increasing in complexity. As a result, more scrutiny and pressure are placed on sponsors, CROs, and sites alike in terms of patient diversity, shortened timelines, and overall clinical trial performance and reliability. Luckily, the industry is responding to these demands with improved tools and insights to better align the right trials with the right sites. By leveraging the latest technology solutions and methods at your disposal to better identify and manage site selection, feasibility, study startup, and trial execution will also become more streamlined and efficient due to performance data transparency between the levels of clinical trial stakeholders. Ultimately, however, decreased trial cycle times and faster delivery of new therapies means patients are the real winners.
About Devana Solutions
Devana Solutions is an innovative cloud-based clinical trial software company that supports real-time collaboration between central research operations professionals and decentralized clinicians serving patients in diverse communities. Our platform bridges the technology access and data divide by seamlessly and securely connecting decentralized researchers to other mission-critical clinical trial systems.
Devana Solutions is an Advarra API Gold Partner that integrates seamlessly with Advarra’s Clinical Conductor CTMS. Learn more about Clinical Conductor CTMS, Devana Solutions, and other Advarra partners.