Jove
Visualize
お問い合わせ
JoVE
x logofacebook logolinkedin logoyoutube logo
JoVEについて
概要リーダーシップブログJoVEヘルプセンター
著者向け
出版プロセス編集委員会範囲と方針査読よくある質問投稿
図書館員向け
推薦の声購読アクセスリソース図書館諮問委員会よくある質問
研究
JoVE JournalMethods CollectionsJoVE Encyclopedia of Experimentsアーカイブ
教育
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab Manual教員リソースセンター教員サイト
利用規約
プライバシーポリシー
ポリシー

関連する概念動画

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

こちらも読む

関連記事

共著者、ジャーナル、引用グラフによってこの研究に関連する記事。

並び替え
Same author

The importance of adequate user feedback for developing appraisal tools for evidence synthesis - the case of TACIT (Tool for Addressing Conflicts of Interest in Trials).

Journal of clinical epidemiology·2026
Same author

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

BMJ (Clinical research ed.)·2026
Same author

Factors influencing the trustworthiness of non-randomized studies of interventions: a survey of international experts.

BMC medicine·2026
Same author

Protocol for a SPIRIT extension for reporting pragmatic and explanatory trial protocols designed using the PRECIS tool (SPIRIT-PRECIS).

Journal of clinical epidemiology·2026
Same author

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

Lancet (London, England)·2026
Same author

Unpacking the black box - a questionnaire study of how medical journals identify and manage conflicts of interest of editors and peer reviewers.

Journal of clinical epidemiology·2026

関連する実験動画

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 声明:ランダム化試験のプロトコルに関する更新されたガイドライン

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

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

JAMA
|April 28, 2025
PubMed
まとめ

更新されたSPIRIT 2025声明は,完全なランダム化試験プロトコルのための証拠に基づいたガイドラインを提供します. これは透明性を確保し,すべての利害関係者のために臨床試験の設計と報告の質を高めます.

さらに関連する動画

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
Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

9.8K

関連する実験動画

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
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
Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

9.8K

科学分野:

  • 臨床試験の方法論
  • 研究報告基準

背景:

  • ランダム化試験プロトコルは,研究計画,実施,および報告に不可欠です.
  • 既存のプロトコルには,設計と実行の重要な要素が欠けていることが多い.
  • SPIRIT (スタンダード・プロトコル・アイテム: 介入試験のための勧告) 声明は,プロトコル完結性を向上させるために2013年に作成されました.

研究 の 目的:

  • ランダム化試験プロトコルにおける最低項目のSPIRITの勧告を体系的に更新する.
  • 最新のエビデンスとベストプラクティスを取り入れることで,ガイドラインの有効性を保ちます.

主な方法:

  • SPIRIT 2013のチェックリストの潜在的な変更を特定するために,スコーピングのレビューと証拠のデータベースが実施されました.
  • SPIRIT/CONSORTの拡張と他の報告ガイドラインが組み込まれました.
  • 3ラウンドのデルフィー調査で317人の参加者と30人の専門家によるコンセンサス会議が改訂の基礎となった.

主要な成果:

  • 更新されたSPIRIT 2025の声明には,試験プロトコルに関する最低34の項目が含まれています.
  • 重要な変更には,新しいオープンサイエンスセクション,有害性や介入の説明に焦点を当て,患者/公衆の関与項目が含まれています.
  • 実施のため,拡張チェックリストと説明文書が作成されました.

結論:

  • SPIRIT 2025の更新された声明は,ランダム化試験プロトコルの透明性と完全性を高めることを目的としています.
  • 研究者,参加者,資金提供者,倫理委員会,ジャーナル,政策立案者にとって 広範な遵守は有益である.
  • この改訂は,進化する研究基準と慣行に合わせてガイドラインを更新することを保証します.