Related Experiment Video
Updated: Jun 10, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Controversies in design and interpretation of adjuvant clinical trials
1Cancer Research UK, Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary, University of London, UK. j.cuzick@qmul.ac.uk
Abstract:
Although aromatase inhibitors are widely used as adjuvant endocrine treatment for hormone-sensitive early breast cancer, the optimal treatment strategy is controversial. Differences in trial design, endpoint definitions, and patient populations preclude straightforward trial comparisons. Standardized, consistent endpoint definitions, focused on efficacy outcomes (e.g., time to recurrence, time to distant recurrence), would allow for more meaningful comparisons. Disease-free survival and overall survival should be secondary endpoints, since they include deaths without recurrence, which can dilute and confuse efficacy evaluations. Distant metastasis is an excellent surrogate for breast cancer death and is available a few years earlier. These changes should lead to more rapid and reliable introduction of improved therapeutic strategies.
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Dosage Regimens: Designs and Approaches
Bioavailability Study Design: Healthy Subjects Versus Patients