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The Challenge of Extraneous Procedures in Study Design

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Journalists in the trade and popular press seized on the most sensational conclusion from the results of a recent Tufts Center for the Study of Drug Development (Tufts CSDD) study, which looked at the frequency and economic impact of collecting extraneous protocol data. The headlines that ran shortly after the results were presented at the DIA 2012 Annual Meeting in Philadelphia tell it all: “Unnecessary trial procedures cost up to US$5 billion a year”; “Clinical Trials Waste Billions of Dollars Through Unnecessary Procedures”; and my personal favorite, “Clinical Trials Can Waste How Much Money?

The real takeaways from this groundbreaking study are far more compelling, though journalists may have a harder time coming up with pithy headlines. The results provide concrete insight into ways that research sponsors can simplify their protocol designs. In so doing, sponsors can really move the needle in improving clinical trial performance while substantially lowering costs. How often has the clinical research enterprise seen billion-dollar opportunities to save money while improving quality, operating efficiency, and patient recruitment and retention?

First, here’s a little background. We analyzed 117 Phase II and III protocols and more than 22,000 individual procedures based on actual data provided by 15 pharmaceutical companies. Medidata Solutions sponsored the study, provided a custom-made data collection solution and contributed data from its PICAS database of negotiated investigator grants.

Now the punch line: we observed that protocols have more endpoints than previously realized and a large proportion of data—and expenses—associated with extraneous procedures. Each protocol had an average 13 endpoints with half of them being tertiary and exploratory in nature. One out of every four procedures performed was classified as “non-core.” And the average direct cost to administer these ancillary and extraneous procedures was $1.1 million per protocol, or 18% of the total. Given all active Phase II and III protocols conducted worldwide each year, we’re looking at between $3 billion and $5 billion in total direct cost to perform “non-core” procedures annually. This conservative estimate doesn’t include indirect costs for personnel and infrastructure required to capture, monitor, clean, analyze, manage and store tertiary and exploratory procedure data.

So what can—and should—research sponsors do with the Tufts CSDD study results? The economic enormity of the problem demonstrated in this study is already playing a part in attracting attention. And that is an important first step. The approach developed in this study can serve as a useful framework for sponsors to identify and understand the amount of extraneous protocol data that they’re collecting. It can also serve to scrutinize, weigh the value and cost of, and—in some cases—remove less essential procedures not tied to a primary or key secondary endpoint.

Ultimately, through simplifying their protocol designs and removing some less essential procedures, research sponsors can dramatically improve data quality and study volunteer recruitment and retention rates. This in turn can accelerate study timelines and lower study costs. Now that’s a sensational conclusion!

Guest Blogger Ken Getz is a senior research fellow and the Director of Sponsored Programs at the Tufts Center for the Study of Drug Development (CSDD).

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