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Correlating Study Setup Metrics: eCRF Design Time and Reuse

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In our March contribution to the Data Analysis blog on Applied Clinical Trials, we tried our hands at correlative data analysis. And, boy, were we surprised by the lack of correlation! We looked at two metrics key to the study setup process. As you may know, eCRF standardization and reuse have been important initiatives at many R&D organizations in recent years to increase efficiency in the study setup process. Two important measures are expected to be improved through increasing the reuse of eCRFs:

  • Study team resources in general and clinical data management resources in particular
  • Cycle time for study setup and deployment—which is generally considered to be on the critical path to study execution

By looking at industry benchmarks from the Medidata Insights metric warehouse, which draws data from more than 1,800 studies across 50+ sponsors, we identified a clear pattern of increased eCRF reuse over the past five years—from about 10% in 2007 to just under 60% in 2011. However, what stood out to us in trying to correlate the data is the apparent lack of similar progress in reduced eCRF design periods. While the overall trend shows a somewhat shorter eCRF design period—from 15.1 weeks in 2007 to 13.9 weeks in 2011—the reduction is not nearly as demonstrable as the increase in eCRF reuse. There are a number of possible explanations for this, including, but not limited to, the following:

  • While the number of study-specific eCRFs needing design work is lower, review cycles for these eCRF forms may be constrained by limited availability of key stakeholders such as the lead physician and biostatistician.
  • Gaps in study setup process improvements may prevent the full realization of the benefits of reuse. This may include drawn-out "confirmatory" review cycles for the standard eCRF forms for each study, in addition to the study-specific eCRF design reviews. It may also include an insistence on retesting standard eCRFs as part of each new study build.

I am very interested to hear your take on these observed trends. Have you seen increased eCRF reuse? Has it corresponded to shorter design periods? How has your study setup process been impacted? Have you seen other benefits, including reduced effort and resources required? Are there process improvement initiatives you’ve undertaken related to eCRF efficiency? What’s been successful?

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