trends & perspectives in clinical research

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ChromoReport: Focusing on Study Startup Performance by Therapeutic Areas

by Craig Morgan

Standardized performance metrics that are actionable drive transparency and process improvement

goBalto releases industry's first study startup performance metrics report

goBalto, announced today the June 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.

Therapeutic area as well as the number and types of clinical procedures involved are key drivers of costs in Phase I - IV clinical trials. According to research by the U.S. Department of Health & Human Services, the therapeutic area with the highest clinical research burden across all phases is respiratory system followed by pain and anesthesia and oncology trials.

Lengthy timelines directly contribute to lower revenues over the course of a drug's lifecycle, increasing the financial burden of drug development. The cost to develop a new pharmaceutical drug now exceeds $2.5B, with the average cost of developing a drug having risen at a rate 7.4 percent higher than inflation over the past two decades, mostly due to rising clinical trial costs. Costs also tend to increase as a drug candidate progresses through each phase, with Phase III becoming "extraordinarily expensive."

There are a number of factors contributing to the length of clinical trials, the industry's focus on treatments for chronic and degenerative diseases (e.g., arthritis, dementia, and cardiac diseases) creates a need for long trials to demonstrate safety for drugs that are meant to be taken over an extended term. These trials face additional challenges with patient and investigator retention, which can in turn cause costly holdups. Numerous administrative and regulatory barriers also create delays that protract the clinical trial approval process. Additionally, the "as needed" nature of trial organization contributes to long trial initiation timeframes, as investigators, staff, study sites, and other resources are retained for the purposes of a single trial and then disbanded.

Another significant trend contributing to higher clinical trial costs is the increased use of health care cost containment strategies where drug sponsors choose to devote more of their clinical research budgets to trials that compare their drug to a competitor drug, as opposed to trials that compare their drug against a placebo. This can lead to increased expenses, as larger trial sizes are needed to demonstrate statistical significance in comparisons of multiple drugs.

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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