trends & perspectives in clinical research

goBalto Chromosome

ChromoReport: Focusing on Economies of Scale in Study Startup

by Craig Morgan

Standardized performance metrics that are actionable drive transparency and process improvement

goBalto December 2017 ChromoReport

goBalto, announced today the December release of the ChromoReport, a quarterly analytical discussion on study startup (SSU), representing over 70 percent of clinical trial sites in phase II & III of the Top 25 pharma companies.

The benefits from clinical research are indisputable. Addressing important scientific questions with efficient trial design and execution attracts new subjects, the latest cutting-edge technologies, high-caliber key opinion leaders and subject matter experts, as well as additional revenue sources.

The trend to outsource clinical trial operations to contract research organizations (CRO) is rooted in intense competition to improve productivity, driving sponsors to contain operational and infrastructure costs while completing projects better, faster and more efficiently. These external service providers can achieve economies of scale unavailable to individual firms when they combine the volumes of multiple companies.

With an anticipated 7.4% compound annual growth rate for the CRO market through 2019, market penetration may reach a hefty 72% by the end of the decade. A recent survey by Worldwide Clinical Trials reveals that 62% of respondents are more likely to engage a CRO partner for clinical research than they were five years ago, demonstrating the increasingly vital role CROs are playing in modern drug development, and the importance of partnering with a CRO that offers medical and scientific expertise - subject matter experts which are more likely to be found on the CRO team, pooling their expertise with that of others.

This transition is important because CROs can offer sponsors a broad array of therapeutic areas combined with savvy project managers – having the expertise, experience and resources to successfully navigate challenges in study startup, such as the Silo Phenomenon. In a recently completed comprehensive study conducted by Tufts Center for the Study of Drug Development (CSDD), Start-up Time And Readiness Tracking (START) II, 2017, found that CROs are investing more in technology and report shorter cycle times across all stages of study startup (i.e., site identification, feasibility assessment, selection and activation) compared to their sponsor counterparts.

Irrespective of organizational structure – expertise, experience and project management are equally important to both groups who face similar challenges and see the same opportunities for improvement.

Economies of scale and scope in R&D are an important determinant of the economic performance of the pharmaceutical industry. One interpretation of the recent wave of mergers in the pharmaceutical industry is that firms are attempting to realize advantages conferred by size in the conduct of R&D.

But what do the industry metrics have to say about economies of scale in clinical trials?

Jeff Kasher
Patient's Can't Wait
"Turning big data into big insights requires analytics that are actionable. Performance metrics must be data-driven, standardized across studies, indication, and therapeutic areas, and timely. They must also, importantly, facilitate a forum for discussion."

Jeff was formerly VP Clinical Innovation and Implementation at Eli Lilly and Company
Jae Chung
President and Founder
goBalto, Inc
"Utilizing overarching cycle times within your own company or team is only the beginning of creating the best results for your company. To truly begin to move toward 'best in class' or 'industry leading' you need to consider your processes and cycle times from a bottleneck perspective, as well as industry standard. By thoroughly understanding the data you will support your teams to make the best decisions to improve study startup, ensuring that the goal of getting protocols to patients faster is achieved, which represents the first step in competing a study on or ahead of schedule."

The ChromoReport is complimentary and can be downloaded from here. For earlier releases of the ChromoReport please visit goBalto's Resource Center.

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