Case Study

Implementing a Study Design Change Late in a Trial for Breast Cancer Indication

Provided By:

PAREXEL

May 10, 2017

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.

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