Unexpected Interim Analysis

Oncology Study

Unexpected Interim Analysis

SPONSOR

A biopharmaceutical company, partnered with a multinational pharmaceutical company, focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options.

PROJECT

A Phase 3 multinational prostate cancer trial, enrolling 1200 patients worldwide, including 395 patients in North America.

CHALLENGE

How do you rapidly adjust when the sponsor unexpectedly asks all vendors to prepare for an interim analysis and gives very short timelines for data collection? Fortunately, the ProTrials monitoring team was completely up to date on monitoring and data collection, which allowed our team to react quickly to the request. In addition, the team was resourced appropriately so we could be flexible and add additional site visits and communication time for queries as needed.

RESULTS

ProTrials exceeded the database readiness goals by having an average of 98% of the data entered, 95% of the data monitored, and less than two queries per patient. By having the database clean, up to date, and the ability to react quickly, the ProTrials team ensured that at any moment the sponsor could conduct an analysis and be confident of the results!

SPONSOR FEEDBACK

“We have worked with ProTrials for years across multiple programs and value their expertise, flexibility and responsive customer service. ProTrials’ seasoned professionals have contributed both domestically and internationally, in-house and in the field, whatever our needs have been ProTrials has been our solution!”

-Sponsor, Sr. Director, Clinical Operations