関連する実験動画
Updated: Jun 8, 2026

07:50
Establishment of a Clinic-based Biorepository
Published on: May 29, 2017
6.9K
BMJに提出された臨床試験における非見通し試験登録の分析:観察研究
David Blanco1, Elizabeth Loder2,3, Sophie Cook3
1Department of Physiotherapy, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Barcelona, Spain dblanco@uic.es.
まとめ
国際医学雑誌編集者委員会 (ICMJE) に将来的に登録されていない多くの臨床試験は,後に影響力のある雑誌に掲載されました. 著者は,ICMJEのガイドラインに従っていると主張したにもかかわらず,しばしば登録の欠陥を明らかにしなかった.
科学分野:
- 臨床試験の登録と公表 倫理学
- 医学雑誌のポリシーとコンプライアンス
背景:
- 臨床試験の将来的な登録は,透明性と科学的誠実性にとって極めて重要です.
- 国際医学雑誌編集者委員会 (ICMJE) は,将来的な登録を推奨しています.
研究 の 目的:
- BMJに提出された臨床試験の予期しない登録に関連する要因を特定する.
- 登録の欠陥,開示の慣行,およびそのような試験の公表状況を調べる.
- 将来の登録に関する著者の主張を評価する.
主な方法:
- BMJ (2019-2023) に提出された239件の未予備登録試験と239件の予備登録試験を比較した観察研究.
- 分析には,登録状況,欠陥,登録の遅延,およびその後の公表の詳細が含まれていました.
- 将来の登録とICMJEの勧告へのジャーナル遵守に関する著者の主張は評価されました.
主要な成果:
- 非将来性登録の減少に関連する要因には,より大きなサンプルサイズ,オセアニアからの著者,より多くの著者,CONSORTの言及,最近の提出,および資金調達が含まれています.
- アジア出身の著者は,将来性のない登録の確率が高い.
- 予備登録されていない試験のうち,83パーセントが予備登録 (中位193日遅延),13パーセントが予備登録されなかった. その多くは後にインパクトファクター誌に掲載され,しばしばICMJEの遵守を主張し,登録問題を明らかにしなかった. 83%の著者が誤って将来の登録を主張した.
結論:
- 予期しない登録を理由にBMJによって拒否された試験は,影響力の高いジャーナルで他の場所で頻繁に掲載されました.
- これらのジャーナルはしばしばICMJEの遵守を主張したが,著者はしばしば登録の欠陥を明らかにしなかった.
- これは,臨床試験登録政策の遵守と執行におけるギャップを強調しています.
関連する概念動画
Observational Studies
Observational studies are a type of analytical study where researchers observe events without any interventions. In other words, the researcher does not influence the response variable or the experiment's outcome.
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One example of...
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One example of...
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...
There are four phases in a clinical trial. A phase one...
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...
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...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Study Designs in Epidemiology
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.

