Of adaptive and factorial designs

A biostatistician’s interpretation of last week’s ODAC

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Donald A. Berry, PhD
Professor and founding chair, Department of Biostatistics, Founding head, Division of Quantitative Sciences, MD Anderson Cancer Center; Senior statistical consultant and founder, Berry Consultants, LLC
Table of Contents

YOU MAY BE INTERESTED IN

Congress settled the FY26 question in February, with NCI receiving $7.352 billion, an increase of $128 million over the prior year. After a year in which cancer center directors spent an extraordinary share of their leadership attention defending the research enterprise, that outcome deserves to be called what it was: a win.
OST-HER2-treated patients showed statistically significant benefit in an interim three-year overall survival data analysis when compared with a combined published historical control arm being used for regulatory interactions. The analysis is from the company’s phase IIb trial for the prevention or delay of recurrence in patients with fully resected, pulmonary metastatic osteosarcoma (the “Metastatic Osteosarcoma Program”).
FDA approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. 
Donald A. Berry, PhD
Professor and founding chair, Department of Biostatistics, Founding head, Division of Quantitative Sciences, MD Anderson Cancer Center; Senior statistical consultant and founder, Berry Consultants, LLC

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login