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Related Concept Videos

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.
Regression Toward the Mean01:52

Regression Toward the Mean

Regression toward the mean (“RTM”) is a phenomenon in which extremely high or low values—for example, and individual’s blood pressure at a particular moment—appear closer to a group’s average upon remeasuring. Although this statistical peculiarity is the result of random error and chance, it has been problematic across various medical, scientific, financial and psychological applications. In particular, RTM, if not taken into account, can interfere when researchers try to extrapolate results...
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
Blind Procedures02:07

Blind Procedures

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...
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: Jul 12, 2026

Determining and Controlling External Power Output During Regular Handrim Wheelchair Propulsion
08:55

Determining and Controlling External Power Output During Regular Handrim Wheelchair Propulsion

Published on: February 5, 2020

Disability as Mere-Difference and What It Means for Randomized Controlled Trials.

Andrew J Barnhart1, Matthias Braun1

  • 1University of Bonn.

The American Journal of Bioethics : AJOB
|July 9, 2026
PubMed
Summary
This summary is machine-generated.

People with disabilities are often excluded from randomized controlled trials (RCTs) due to explicit and implicit criteria. This study argues for anti-ableist research practices and regulatory changes to ensure disability inclusion in clinical trials.

Keywords:
Disabilityclinical equipoiseethicsrandomized controlled trialsregulations

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Area of Science:

  • Clinical Research Ethics
  • Health Equity
  • Disability Studies

Background:

  • Systematic exclusion of people with disabilities from randomized controlled trials (RCTs) is prevalent, often due to explicit or implicit criteria.
  • Many disability-related exclusions in RCTs could be addressed through reasonable design adaptations.
  • Exclusionary practices stem from methodological oversight and ableist assumptions within research, regulations, and clinical equipoise.

Purpose of the Study:

  • To critique the 'mere-difference' view of disability within research ethics.
  • To analyze global clinical trial regulations concerning disability.
  • To propose modifications to clinical equipoise and research protocols to enhance disability inclusion.

Main Methods:

  • Critique of the 'mere-difference' view using power relations and standpoint epistemology.
  • Comparative analysis of clinical trial regulations in 10 countries/regions (US, EU, UK, Canada, Japan, Singapore, China, Kenya, Nigeria, Brazil).
  • Examination of how the 'mere-difference' view can inform clinical equipoise and research protocols.

Main Results:

  • Claims of value-neutrality in disability require explicit anti-ableist commitments to address structural injustice.
  • Disability lacks mandatory inclusion reporting or exclusion justification requirements in global regulations, unlike gender, age, or race/ethnicity.
  • Modified 'mere-difference' view can reshape clinical equipoise by incorporating disabled voices and establishing genuine uncertainty.

Conclusions:

  • Clinical trial protocols must mandate explicit justification for disability-based exclusions.
  • Global harmonization efforts, such as ICH E6(R3) guidelines, should include explicit language promoting disability inclusion.
  • Addressing ableist assumptions is crucial for equitable participation in clinical research.