Industry Standards Research

Industry Standard Research has recently released its 3rd annual "CRO Quality Benchmarking Report." The report not only profiles the delivery quality of leading CROs, but also provides a wealth of information that relates to larger industry trends, including the value of recruitment speed.  

After three consecutive years of collecting data, a critical mass to reflect upon has been collected. The basic statistics class axiom: "It takes three data points to make a trend," has been met.  

Source: ISR Reports: Survey participants were asked to indicate their preference for one benefit over the other. n=160 (2009); 150 (2010); 169 (2011)			

After examining the data, it is clear and undeniable: sponsors are expressing an unmet need for faster recruitment. It's not difficult to make sense of this. Project manager job appraisals and compensation are tied to trial speed. In addition, the rule-of-thumb is that for each day's delay in getting a drug to market, the manufacturer loses a million dollars in revenue. Perhaps to some readers this qualifies as a "duh" take-away, but the magnitude of the disparity remains interesting—price is important too.  

Patient recruitment continues to be a source of consternation in the industry, and service providers are constantly measured against this metric. The ones that do it well will establish loyalty among their customers and the ones that do it poorly will struggle. 

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Industry Standard Research has recently released its 3rd annual "CRO Quality Benchmarking Report." The report not only profiles the delivery quality of leading CROs, but also provides a wealth of information that relates to larger industry trends, including the value of recruitment speed.

Value of Time and Money

The perennial sponsor complaint: "Outsourcing costs too much." The perennial CRO response: "If you didn't assign so much internal resource to manage us, it would be cheaper."  			

Well, it's true and both groups acknowledge it. Over 90% of sponsor and CRO respondents indicate that resources are assigned to oversee outsourced studies. While CROs and sponsors agree that oversight may be excessive, they do not agree on the consequences. In ISR's 

 report, 78% of CROs believe that oversight increases the amount of time necessary to complete a clinical trial compared to only 25% of sponsors. Sponsors hold what may be considered contradictory beliefs regarding their oversight of CROs. They believe their own oversight to be excessive; however many believe there are benefits too. Nearly half of the sponsor respondents indicated oversight reduces time; 53% believe it either reduces costs or has no impact on costs; and 77% believe it increases data quality.  

From ISR's perspective, the size, global scope, and complexity of today's clinical trials are justification enough for a degree of oversight. Pharma's business challenge is identifying when enough is enough; the point when investing in more oversight no longer returns a better clinical trial. Service providers' business challenge is to better understand why sponsors insist on oversight, and then develop systems, training, and people to arrive at the right balance.  

This is an evolving issue and having a better understanding of development outsourcing models as well as sponsor and service provider oversight rationale are important first steps to increasing trial efficiency and lowering industry clinical development spending. Achieving the right oversight balance can have profound effects on both individual development programs and companies.  

The perennial sponsor complaint: "Outsourcing costs too much." The perennial CRO response: "If you didn't assign so much internal resource to manage us, it would be cheaper."

Industry Standards Research

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Value of Time and Money

Sponsor Oversight of CROs