Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Randomized Experiments01:13

Randomized Experiments

6.6K
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...
6.6K
Clinical Trials01:16

Clinical Trials

6.6K
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...
6.6K
Blinding01:11

Blinding

2.3K
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.
2.3K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

106
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,...
106
Hazard Ratio01:12

Hazard Ratio

64
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...
64
Ethics in Research01:56

Ethics in Research

22.8K
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.
22.8K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Author Correction: The STARD-AI reporting guideline for diagnostic accuracy studies using artificial intelligence.

Nature medicine·2026
Same author

Measurement of ethnicity in clinical trials: Delphi survey and consensus statement.

BMJ (Clinical research ed.)·2026
Same author

Helping Underdeveloped Lungs with Cells (HULC-2): mesenchymal stromal cells in extreme preterm infants at risk of developing bronchopulmonary dysplasia - a study protocol of a phase 2 multicentre double blind randomised controlled trial in Canada.

BMJ open·2026
Same author

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

Lancet (London, England)·2026
Same author

Updated International Patient Decision Aid Standards (IPDAS version 5.0): modified Delphi, evidence informed consensus process.

BMJ (Clinical research ed.)·2026
Same author

Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration.

BMJ (Clinical research ed.)·2026

Related Experiment Video

Updated: May 9, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
00:04

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

Published on: September 20, 2019

10.6K

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, ON, M5S 1B2, Canada anwen.chan@utoronto.ca.

BMJ (Clinical Research Ed.)
|April 28, 2025
PubMed
Summary

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

More Related Videos

Virtual Prism Adaptation Therapy: Protocol for Validation in Healthy Adults
06:12

Virtual Prism Adaptation Therapy: Protocol for Validation in Healthy Adults

Published on: February 12, 2020

6.7K
Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
08:22

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

8.0K

Related Experiment Videos

Last Updated: May 9, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
00:04

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

Published on: September 20, 2019

10.6K
Virtual Prism Adaptation Therapy: Protocol for Validation in Healthy Adults
06:12

Virtual Prism Adaptation Therapy: Protocol for Validation in Healthy Adults

Published on: February 12, 2020

6.7K
Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
08:22

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

8.0K

Area of Science:

  • Clinical Trials Methodology
  • Research Integrity and 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 developed in 2013 to improve protocol completeness.

Purpose of the Study:

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

Main Methods:

  • A scoping review and evidence database were used to identify potential changes to the SPIRIT checklist.
  • Recommendations from SPIRIT/CONSORT extensions and other reporting guidelines were integrated.
  • A three-round Delphi survey involving 317 participants and a consensus meeting with 30 experts refined the proposed modifications.

Main Results:

  • The updated SPIRIT 2025 statement includes 34 evidence-based minimum items for trial protocols.
  • Key changes involve a new open science section, enhanced focus on harms and comparators, and a new item on patient and public involvement.
  • The update also features a revised checklist, a schedule diagram, an expanded checklist, and an explanation/elaboration document.

Conclusions:

  • Widespread adoption of the SPIRIT 2025 statement can significantly improve the transparency and completeness of randomized trial protocols.
  • Enhanced protocols benefit investigators, participants, funders, ethics committees, journals, and policymakers.
  • The updated recommendations aim to bolster the reliability and utility of clinical trial evidence.