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Updated: Jul 17, 2026

Enabling High Grayscale Resolution Displays and Accurate Response Time Measurements on Conventional Computers
Published on: February 29, 2012
Measuring response in a post-RECIST world: from black and white to shades of grey
Laura C Michaelis1, Mark J Ratain
1Section of Hematology/Oncology, University of Chicago, 5841 S. Maryland Avenue, MC 2115, Chicago, Illinois 60637, USA.
Abstract:
The unprecedented pace of therapeutic development in oncology has created a climate in which the traditional methods of evaluating agent activity might no longer be adequate. How is the field transitioning to new endpoints in early drug development and what are the difficulties in this transition? Here, we will explore the historical context for the current criteria for tumour response evaluation and some of the pitfalls in using these standards when testing newer anticancer agents for activity. We will argue that the current drug development environment dictates different outcome measurements and therefore more imaginative and rigorous early-phase trial designs.
Insights
The rapid advancement of cancer therapies necessitates new ways to measure drug effectiveness in early development. Traditional methods are inadequate, requiring more innovative trial designs for novel anticancer agents.
Area of Science:
- Oncology
- Drug Development
- Clinical Trials
Background:
- The rapid pace of therapeutic innovation in oncology challenges traditional methods for evaluating anticancer agent activity.
- Current criteria for tumor response evaluation may be insufficient for assessing novel therapeutic agents.
- There is a need to adapt early drug development strategies to the evolving landscape of cancer treatment.
Approach:
- This analysis examines the historical context of current tumor response evaluation standards.
- It explores the difficulties and pitfalls associated with using these traditional standards for newer anticancer agents.
- The study advocates for revised outcome measurements and more imaginative early-phase trial designs.
Key Points:
- Traditional endpoints for evaluating anticancer agent activity may no longer be adequate due to rapid therapeutic advancements.
- The transition to new endpoints in early drug development faces significant challenges.
- Existing criteria for tumor response evaluation present limitations when applied to novel anticancer agents.
Conclusions:
- The current drug development environment demands different outcome measurements for anticancer agents.
- More imaginative and rigorous early-phase trial designs are essential for accurately assessing novel therapies.
- Adapting evaluation methods is crucial for effective oncology drug development.
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