Rapid Dermatology Clinical Trial Start Up

We helped our client get the right vendors on the right things for a rapid start up, and their trial ran faster!

A sponsor needed to ensure that enrolment was completed for their dermatology study by a certain time to ensure funding to continue research for the product the following year. A bid defence was completed in late January and subsequently awarded the study the first week in February. At this time, no protocol was available, however the protocol would be available by mid-March. The goal was to identify and recruit 40 sites to enrol 200 subjects, enrolment to be completed by Oct to have 6-month data for interim analysis by the following March.

A protocol synopsis with Inclusion/Exclusion criteria, schedule of assessments, and IP information was initially available. Sites with experience in that specific disease were prioritized and tiered based on enrollment in previous trials and start up speed. Outreach to those sites began immediately and it made clear that the first Site Initiation Visit would be early April. Sites were also quickly followed up to determine interest. In addition, vendors that were required (central lab, photography, rater training, and central advertising) were all contacted upon study award.

For vendors, they typically will not start without a solid draft protocol. It was understood that as soon as that became available in early, March, they would begin working on set-up for the study. The sponsor agreed to cover costs for any changes. Regular calls were scheduled with vendors to review set-up requirements, vendor specific documents, etc. to speed up process, and ensure sites readiness by mid-April

Due to the commitment of the sites, the vendors (who set-up in approximately 6 weeks), and team working on this trial, the first site was initiated by early April with patient enrolment starting immediately. At that time, approximately 30% of the sites were ready to start. With this quick start of a significant number of sites from the beginning and the use of central advertising, patient numbers were quickly achieved and enrolment ended ahead of schedule for this study.

First patient enrolment in 3 months from project award.

Costs are based on project requirements.