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Related Concept Videos

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.
Bias in Epidemiological Studies01:29

Bias in Epidemiological Studies

Biases can arise at various stages of research, from study design and data collection to analysis and interpretation. Recognizing and addressing these biases is essential to ensure the validity and reliability of epidemiological findings.Broadly speaking, biases in epidemiology fall into three main categories: selection bias, information bias, and confounding. A more detailed description of possible biases is:
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...
Bias01:22

Bias

Bias refers to any tendency that prevents a question from being considered unprejudiced. In research, bias occurs when one outcome or answer is selected or encouraged over others in sampling or testing. Bias can occur during any research phase, including study design, data collection, analysis, and publication.
In statistics, a sampling bias is created when a sample is collected from a population, and some members of the population are not as likely to be chosen as others (remember, each member...
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...
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...

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Related Experiment Video

Updated: Jul 5, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

[PCPT trial: expected bias and their management].

J Irani1

  • 1Service d'Urologie de l'Hôpital La Milétrie, Université Poitiers, CHU Poitiers, France. j.irani@chu-poitiers.fr

Progres En Urologie : Journal De L'Association Francaise D'Urologie Et De La Societe Francaise D'Urologie
|September 26, 2008
PubMed
Summary
This summary is machine-generated.

The Prostate Cancer Prevention Trial (PCPT) evaluated finasteride for prostate cancer prevention. Methodological challenges were addressed to ensure accurate results, concluding systematic biopsies are the most reliable endpoint.

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E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

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Last Updated: Jul 5, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

Published on: August 1, 2019

Area of Science:

  • Urology
  • Oncology
  • Clinical Trials

Background:

  • The Prostate Cancer Prevention Trial (PCPT) investigated finasteride's efficacy in preventing prostate cancer.
  • The trial faced methodological challenges requiring adjustments to minimize bias.

Purpose of the Study:

  • To compare prostate cancer incidence between men receiving finasteride and those receiving a placebo.
  • To address and mitigate potential biases within the study protocol.

Main Methods:

  • Adjusted Prostate-Specific Antigen (PSA) thresholds due to finasteride's 50% reduction effect.
  • Modified biopsy protocols to prioritize lateral peripheral cores, accounting for reduced gland volume.
  • Accounted for patient adherence and placebo arm contamination.

Main Results:

  • Identified and analyzed various sources of bias, including increased rectal exam sensitivity and prostatic resections in the placebo arm.
  • Implemented strategies to manage identified biases, ensuring a more accurate assessment of finasteride's effect.
  • Systematic end-of-trial biopsies emerged as the most robust endpoint for analysis.

Conclusions:

  • Despite methodological difficulties, the PCPT trial implemented solutions to minimize bias.
  • The study highlights the importance of robust endpoint selection in clinical trials.
  • Systematic end-of-trial biopsies provide a reliable measure for evaluating prostate cancer incidence.