Increased eCRF Reuse Not Impacting Cycle Times?

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-03-01-2012, Volume 21, Issue 3

Medidata

In the ongoing search for resource and timeline efficiencies, Clinical R&D organizations have paid particular attention over the years to data standards and reuse. This has included the standardization and reuse of case report forms (CRFs) and more recently EDC-based CRFs (eCRFs). 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 eCRF set-up and deployment—which is generally considered to be on the critical path to study execution.

The graph illustrates that clinical R&D organizations have indeed realized dramatically higher levels of eCRF reuse over the past five years—from about 10% in 2007 to just under 60% in 2011. The data was compiled from the Medidata Insights database comprising close to 1,800 studies from 52 contributing sponsors. As evidenced in this data, and bolstered by first-hand feedback from customer-facing teams, there is a broad industry trend toward greater reuse.

However, somewhat unexpected is the apparent lack of corresponding progress in reduced eCRF design periods. The graph shows that the overall trend is somewhat lower—from 15.1 weeks in 2007 to 13.9 weeks in 2011. However, 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 less, review cycles for these eCRF forms may be strained due to limited availability of key stakeholders such as the lead physician and biostatistician.

  • Gaps in 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 re-testing standard eCRFs as part of each new study build.

Medidata is interested to hear your take on these observed trends. Have you seen increased eCRF reuse? Has it corresponded to shorter design periods? Have you seen other benefits including reduced effort and resources required? Continue to stay tuned to this blog as we'll be delving further into the Insights metric data throughout 2012.

—Medidata Solutions, www.mdsol.com