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Despite Warnings, Protocols are Still Getting More Complex

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Complexity is not a new topic for this blog. We’ve discussed eCRF complexity before and trial complexity has been a hot topic in industry trade publications for years. But as we at Medidata have moved to a “concept to conclusion” view of the clinical process, we’ve come to realize that the protocol plays a primary role in trial complexity. Unnecessarily complex protocols can significantly impact downstream processes and operational risks, and while some protocols need to be complex there are too many that have extraneous procedures and assessments.

Until recently, there was no easy way to view protocol complexity across the industry or across an entire organization at any given point in time. But thanks to a recent update to Medidata Insights, we can.

So to better understand protocol complexity, we dug into the Medidata Insights metrics warehouse to highlight this trend across the industry. Not surprisingly, the Phase II and III data found there show that clinical studies have grown significantly more complex over the past decade. What caught our attention was that after the large increase in the metric in the first half of the past decade—and despite continued warnings from experts on the topic—complexity continues on an upward, though admittedly less steep, trend.

So what’s the impact of increased protocol complexity?

  • According to the Tufts Center for the Study of Drug Development, increased execution burden on sites can lead to more costly clinical trials and potentially greater issues with site training and performance.1
  • 15–30 percent of data collected during the average clinical trial process is never used in a New Drug Application.

This increase in added complexity without corresponding added value increases direct costs while negatively impacting patient recruitment and retention. This happens as increased procedure frequency and invasiveness negatively impact the patient experience in clinical trials:

  • The screen-to-complete ratio was 52 percent from 1999 to 2002 and dropped to 28 percent from 2003 to 2006.2
  • Screen failure rates are significantly costly for sponsors; we estimate the average cost per failure across the industry to be roughly $1,200.3

As discussed in previous posts, data from the Insights metrics warehouse indicate that three other key metrics are also steadily rising: eCRF complexity, number of on–site monitoring days and the amount of source document verification (SDV) performed during each on-site day. A correlation among these measures is a reasonable conclusion–it is apparent that an increase in protocol complexity is driving an increase in eCRF complexity and design timelines, monitoring costs and the burden on both sites and patients.

Despite the significant amount of discussion on the topic at hand, the trend of increasing protocol complexity continues. Given the pressure to control costs and streamline trials, organizations need to focus on the protocol design process more than ever, ensuring that all of the prescribed procedures and assessments are necessary to support key study objectives.

1 Assessing the Impact of Protocol Design Changes on Clinical Trial Performance, Tufts Center for the Study of Drug Development, Tufts University, Boston, MA

Trends and Implications of Increasingly Complex Protocol Designs, Tufts Center for Study of Drug Development, 2009

3 Medidata CROCAS® database, 2012 More about Stephen Young

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