Related Experiment Video

Updated: Jul 9, 2026

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)
04:11

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)

Published on: June 9, 2026

[Randomised phase II trials in oncology]

Pascal Piedbois1

  • 1AstraZeneca, 1, place Renault, 92844 Rueil-Malmaison Cedex. pascal.piedbois2@astrazeneca.com

Bulletin Du Cancer
|December 7, 2007
PubMed

Insights

Phase II trials aim to detect drug efficacy signals. This paper explores randomized Phase II trial designs to mitigate bias and prevent premature drug development termination.

Area of Science:

  • Oncology
  • Clinical Trials
  • Drug Development

Context:

  • Phase II trials are critical for identifying early drug efficacy signals.
  • A significant risk in Phase II studies is falsely concluding a drug lacks efficacy, halting promising treatments.
  • Oncology increasingly utilizes randomized Phase II trials over non-randomized designs.

Purpose:

  • To describe various randomized Phase II trial designs.
  • To explain the principles, strengths, and limitations of these designs.
  • To address the pitfall of erroneous conclusions regarding drug activity.

Summary:

  • Randomization in Phase II trials helps control patient selection bias, a common issue in non-randomized studies.
  • Patient selection bias can skew results by chance, recruiting populations with unexpectedly high or low response risks.
  • The paper details different randomized Phase II trial methodologies and their associated benefits and drawbacks.

Impact:

  • Improving the reliability of early-phase drug evaluation in oncology.
  • Reducing the risk of discontinuing effective cancer therapies due to flawed trial design.
  • Providing a framework for designing robust and informative randomized Phase II trials.

More Related Videos

Heterogeneity Mapping of Protein Expression in Tumors using Quantitative Immunofluorescence07:54

Heterogeneity Mapping of Protein Expression in Tumors using Quantitative Immunofluorescence

Published on: October 25, 2011

Related Concept Videos

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...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Treatment Resistent Cancers02:56

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Treatment Resistant Cancers02:56

Treatment Resistant Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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...
Cancer Survival Analysis01:21

Cancer Survival Analysis

Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...