Background

The time required from receipt of a finalized protocol at a clinical trial site to enrollment of the first study subject is often unnecessarily prolonged. Assessment and attempts to reduce the time required for study start-up (SSU) activities are complicated by the lack of standard, industry-wide metrics and scarce data on the variability of performance across sites and study types. Standardized SSU metrics could be used by sites to compare their performance against others and to improve their internal processes. Study sponsors could use the information to compare and select sites to participate in clinical trials. Public reporting of these metrics also could drive improvement through competition across facilities.

 

Goal

Identify, standardize, and quantify components of SSU activities, with the larger goal of reducing the time required to enroll study participants.

 

Methods and Results (updated November 2011)

Workstream 1

Workstream 2

Workstream 3

Team Organization
 

Funding and Other Support

Financial support provided by the CTTI general project fund and grant U19 FD003800 from the U.S. Food and Drug Administration (FDA). Volunteer time and donated resources provided by Duke University, Pfizer Inc., and Rx Trials Inc.

 

Contact Information

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