Related Experiment Video

Updated: Jun 5, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

Making the investigational oncology pipeline more efficient and effective: are we headed in the right direction?

Patricia M LoRusso1, Aparna B Anderson, Scott A Boerner

  • 1Karmanos Cancer Institute, Wayne State University, Detroit, Michigan 48201, USA. lorussop@karmanos.org

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|December 21, 2010
PubMed

Insights

Novel oncology therapeutics require innovative clinical trial designs. Early-phase trials (Phase I and II) are crucial for defining endpoints and patient subpopulations to optimize drug development.

Area of Science:

  • Oncology
  • Molecular Biology
  • Clinical Pharmacology

Background:

  • Advances in cancer biology have led to targeted oncology therapeutics.
  • Clinical drug development is resource-intensive and time-consuming.
  • Traditional efficacy endpoints may not fully capture the value of novel targeted agents.

Purpose of the Study:

  • To highlight the necessity of novel clinical trial designs for targeted oncology therapeutics.
  • To emphasize the importance of identifying patient subpopulations early in development.
  • To underscore the role of early-phase trials in optimizing drug development pathways.

Main Methods:

  • Review of current challenges in oncology drug development.
  • Discussion of the limitations of traditional clinical trial endpoints.
  • Emphasis on the strategic use of Phase I and II clinical trials.

Main Results:

  • Novel clinical trial designs are essential for efficient drug development.
  • Nontraditional endpoints and early subpopulation identification are critical.
  • Phase I and II trials provide vital data for prioritizing promising agents.

Conclusions:

  • Innovative clinical trial designs are necessary to navigate the complexities of targeted oncology drug development.
  • Early identification of patient benefit and risk through Phase I/II trials is vital.
  • Rethinking trial paradigms can accelerate the delivery of effective cancer therapies.

More Related Videos

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies13:24

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies

Published on: April 11, 2016

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo09:19

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo

Published on: February 6, 2015

Related Concept Videos

Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
Combination Therapies and Personalized Medicine02:50

Combination Therapies and Personalized Medicine

Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...