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ChromoReport: Focusing on Authorship and Review in Contract Timelines in Study Startup

by Craig Morgan
08Oct2018

Standardized performance metrics that are actionable drive transparency and process improvement

goBalto September 2018 ChromoReport

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

The clinical trials sector is awash in metrics, and while early ones generally made broad determinations, such as which sites are top enrollers, the trend is toward more precise metrics that are actionable and help predict where bottlenecks may occur. This is a radical change for stakeholders looking to resolve one of study startup's most enduring challenges – improving budget and contract cycle times.

For years, this laborious step has ranked as the lengthiest of study startup activities, and recent data suggest it remains the primary cause of site activation failure. Some 50.5% of sponsors and 54.3% of contract research organizations (CROs) cite it as the main culprit. Further evidence of contracting problems stems from earlier research, which found that the time period from pre-site visit to contract and budget execution represents the majority of study startup cycle time, 76%, and can average eight months. In addition, a study in which 20,000 contracts were analyzed suggested that site contract cycle times have doubled in recent years. The industry median jumped from 1.5 months in 2010-2011 to more than three months in 2014-2015. With the pharmaceutical industry's intense focus on better performance, stakeholders are ready to embrace strategies that identify and help shorten long contract cycle times.

Fundamental to this change are the growing numbers of forward-thinking organizations who understand how older metrics, often based on a single start and stop time, fail to appreciate what each step entails. To correct this problem, many stakeholders are looking to industry initiatives to break down key benchmarks into their components – the sub-steps – better identify where bottlenecks might occur. Addressing the budget and contract cycle involves moving away from the single data point approach, such as "time from pre-site visit to execute all site level contracts". This is not a useful metric unless it is based on its sub-steps, such as:

  • When site contract language is ready
  • When first contract language package is sent
  • First contract language review
  • Cycle duration and frequently
  • When last contract language is ready for execution
  • Completion of regulatory submissions and approvals
  • When all contracts are executed

Measuring these sub-steps is critical to building prediction models that identify processes causing bottlenecks. With a predictive capability, grounded in workflow-based metrics, it becomes possible to condense contract cycle times, presenting a significant opportunity for optimizing clinical trial operations.

What do industry metrics say about the review durations of the investigative sites vs. sponsors/CROs?

Site level contract configuration

Figure 1. Site level contract configuration

Jeff Kasher
JEFF KASHER
President
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
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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