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Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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...

Clinical Trials

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...

Blinding

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.

Clinical Trials: Overview

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...

Randomized Experiments

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...

Hazard Ratio

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: Jun 23, 2026

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

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

Published on: September 20, 2019

International Stakeholder Guidance for Improving Informativeness of Randomized Clinical Trials.

Sarah R Prowse¹, Miriam Brazzelli¹, Heidi R Green²

¹Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom.

JAMA Network Open

|June 22, 2026

Summary

Improving randomized clinical trials (RCTs) requires stakeholder input on trial importance, design, feasibility, integrity, and reporting. Key insights include enhancing design review, statistical expertise, patient partnerships, and skills-based training to reduce research waste and boost public trust.

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Last Updated: Jun 23, 2026

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

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Published on: September 20, 2019

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

Area of Science:

Clinical Research
Biostatistics
Health Services Research

Background:

Randomized clinical trials (RCTs) are crucial for evidence-based medicine but often suffer from poor design, unaddressed questions, and inadequate reporting, leading to research waste.
Understanding stakeholder perspectives is essential to identify and address persistent issues affecting the informativeness of RCTs.

Purpose of the Study:

To explore global stakeholder perspectives on improving RCT informativeness.
To identify actionable strategies within a 5-point framework: trial importance, design, feasibility, integrity, and reporting.

Main Methods:

A qualitative study involving semistructured, one-on-one interviews with 55 international professionals involved in RCT funding, design, sponsorship, and oversight.
Interviews were conducted online between October 2024 and March 2025.
Thematic analysis was employed, using a deductive framework refined by inductive coding.

Main Results:

Stakeholders emphasized the need for enhanced scientific design review post-peer review and pre-funding, alongside requiring qualified trial statisticians.
Building trust requires early patient partnerships, and ensuring trial integrity necessitates skills-based training beyond Good Clinical Practice.
Feasibility, particularly robust recruitment and retention plans, is critical for reliable research question answering.

Conclusions:

International stakeholder interviews provide valuable insights for improving RCT pre-funding, peer review, design, and conduct.
Implementing these improvements is vital for ensuring RCTs consistently yield reliable health evidence and strengthen public trust in science.