Implementing a Study Design Change Late in a Trial for Breast Cancer Indication
This eligibility study for a breast cancer indication began as a single-read model with six radiologists assigned. Based on the data submitted, the sponsor identified favorable results when the trial was well underway.
Consequently, the sponsor sought a more robust approach, requiring a trial design change involving a double radiology read with adjudication. Now on a fast track, with an interim analysis delivery date in about two months, the study’s regulatory submission goal was far sooner than originally anticipated.
You can also download a related podcast entitled “Rescue Studies: Key Considerations for Getting Your Study Back on Track” with the below link.