Related Experiment Video
Updated: May 13, 2026

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
Published on: June 21, 2018
Omics-based clinical trial designs
1International Drug Development Institute, Louvain-la-Neuve, Belgium. marc.buyse@iddi.com
Purpose Of Review:
The derivation of signatures using -omics technologies is increasingly integrated in the design of clinical trials in oncology. In this review, we investigate the clinical trial designs for the validation of prognostic and predictive signatures.
Recent Findings:
Using real-life breast cancer trial examples, we highlight the pros and cons of clinical utility designs for prognostic signatures. For predictive signatures, we first review alternative procedures to test the effect of treatment in the overall population as well as in the signature-positive or signature-negative subgroup. We proceed to show why the recent literature on signature-based strategy designs discourages the use of this design. We conclude by discussing adaptive signature designs to identify and validate a signature in a single trial using cross-validation techniques.
Summary:
Use of -omics technologies should not be an add-on to clinical trials, it must become an integral part of their design.
More Related Videos
13:24Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
Published on: April 11, 2016
10:27Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
Published on: July 25, 2020
Related Concept Videos
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Clinical Trials
There are four phases in a clinical trial. A phase one...
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Study Designs in Epidemiology
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
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...