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Related Concept Videos

Randomized Experiments01:13

Randomized Experiments

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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
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Clinical Trials01:16

Clinical Trials

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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.
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Blinding01:11

Blinding

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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.
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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,...
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Hazard Ratio01:12

Hazard Ratio

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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...
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Ethics in Research01:56

Ethics in Research

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Updated: May 9, 2025

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SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.

An-Wen Chan1, Isabelle Boutron2,3, Sally Hopewell4

  • 1Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.

Plos Medicine
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Summary

The updated SPIRIT 2025 guidelines enhance randomized trial protocols with new items on open science and patient involvement, improving transparency for all stakeholders.

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Area of Science:

  • Clinical Trials
  • Research Methodology
  • Scientific Reporting

Background:

  • Randomized trial protocols are crucial for study planning, conduct, and reporting.
  • Existing protocols often lack completeness in key design and conduct elements.
  • The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was established in 2013 to improve protocol completeness.

Purpose of the Study:

  • To systematically update the SPIRIT recommendations for minimum items in randomized trial protocols.
  • To ensure the SPIRIT guidance remains current with evolving evidence and best practices.

Main Methods:

  • A scoping review and project-specific database were used to identify potential changes to the SPIRIT checklist.
  • Recommendations from SPIRIT/CONSORT extensions and other reporting guidelines were incorporated.
  • A three-round Delphi survey with 317 participants and a consensus meeting with 30 experts were conducted.

Main Results:

  • The SPIRIT 2025 statement includes 34 evidence-based minimum items for trial protocols.
  • Key updates include a new open science section, enhanced focus on harms and comparators, and patient involvement.
  • A new item addresses patient and public involvement in trial design, conduct, and reporting.

Conclusions:

  • The updated SPIRIT 2025 statement aims to improve the transparency and completeness of randomized trial protocols.
  • Widespread adoption can benefit investigators, participants, funders, and regulatory bodies.
  • Enhanced protocols facilitate better study planning, conduct, reporting, and external review.