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Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Blinding01:11

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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...
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...
Hazard Ratio01:12

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial evaluating a...

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Related Experiment Video

Updated: May 8, 2026

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
10:27

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Published on: July 25, 2020

Navigating Evidence Standards: Stakeholder Perspectives on External Controls and Randomization in Cancer Trials.

Sarah E Heynemann1,2, Wendy L Lipworth3, Sue-Anne McLachlan4,5

  • 1Sydney Health Ethics, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

Asia-Pacific Journal of Clinical Oncology
|May 7, 2026
PubMed
Summary
This summary is machine-generated.

Randomized controlled trials (RCTs) are challenged by cancer subtype complexity and cost. External controls offer potential but raise bias concerns, necessitating careful balancing of evidence trustworthiness, efficiency, and fairness in oncology decision-making.

Keywords:
control groupexternal controlsoncologyrandomized controlled trialsreal‐world evidence

Related Experiment Videos

Last Updated: May 8, 2026

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
10:27

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Published on: July 25, 2020

Area of Science:

  • Oncology
  • Clinical Trials Methodology
  • Health Economics

Background:

  • Randomized controlled trials (RCTs) are the gold standard for cancer therapy evidence but face challenges like increasing cancer subtyping, high costs, and ethical issues.
  • External controls, using real-world data for comparative analyses, are gaining attention as an alternative when RCTs are infeasible.
  • Concerns exist regarding potential bias and data veracity with external controls, and regulatory guidance varies globally.

Purpose of the Study:

  • To explore stakeholder perspectives on the utility and challenges of using external controls in oncology clinical trials.
  • To understand the balance between methodological rigor and practical considerations in cancer evidence generation.

Main Methods:

  • Qualitative study involving 52 semi-structured interviews.
  • Interviewees included diverse stakeholders: trialists, statisticians, ethicists, ethics review board members, industry representatives, and regulatory and reimbursement body representatives.

Main Results:

  • Stakeholders expressed support for randomization but acknowledged its limitations in certain contexts.
  • There was consideration of the potential utility of external controls in oncology.
  • The relationship between external controls and public decision-making processes was explored.

Conclusions:

  • The generation of evidence for cancer therapies involves inherent values beyond technical considerations.
  • Further research is needed to systematically identify, articulate, and balance the values of trustworthiness, efficiency, and fairness in using external controls.