臨床試験を登録する
Kay Dickersin1, Drummond Rennie
1Center for Clinical Trials and Evidence-based Healthcare, Brown Medical School, Providence, RI 02912, USA. kay_dickersin@brown.edu
JAMA
|July 24, 2003
まとめ
すべての臨床試験が登録されていることを保証することは,出版バイアスを防止し,患者の信頼を維持するために非常に重要です. 総合的な臨床試験登録は,データのアクセシビリティを改善し,医学知識を向上させることで,患者,医師,研究者に利益をもたらします.
科学分野:
- 医学研究倫理 医学研究倫理
- 臨床試験の管理について
- 科学的な出版物 科学的な出版物
背景:
- 開始された臨床試験に関する不完全な情報は,世界的な懸念事項です.
- ポジティブな結果がネガティブな結果よりも優れている出版バイアスは,医学的な証拠を歪曲します.
- 総合的な臨床試験登録の欠如は,患者,研究者,倫理委員会間の信頼を損なう.
研究 の 目的:
- 総合的な臨床試験登録の必要性を強調する.
- 未開示の試験データの倫理的影響,特に業界が支援する研究における倫理的影響に対処する.
- 普遍的な臨床試験登録を確保するために,すべての利害関係者からの即時,協調的な行動を提唱する.
主な方法:
- この研究は,概念的分析と倫理的議論である.
- 臨床試験の登録が不完全な結果について検討しています.
- 出版バイアスの役割とその医学知識への影響について考察しています.
主要な成果:
- すべての臨床試験を登録しないことは,医学研究の歪んだ理解につながります.
- 未開示の否定的または不確実な結果は,重大な倫理的違反を意味します.
- 透明性の欠如は,金融利害関係のある業界が後援する臨床試験に特に影響を及ぼします.
結論:
- 総合的な臨床試験登録は,科学的誠実さと公衆の信頼のために不可欠です.
- 研究者,機関,編集者,政策立案者を含むすべての関係者は,普遍的な試験登録を優先しなければなりません.
- すべての試験にユニークな識別子を導入することで,データのアクセシビリティが向上し,出版バイアスと闘い,医療の進歩が加速されます.
関連する概念動画
01:13Data Collection by Experiments
Data collection is a systematic method of obtaining, observing, measuring, and analyzing accurate information. An experimental study is a standard method of data collection that involves the manipulation of the samples by applying some form of treatment prior to data collection. It refers to manipulating one variable to determine its changes on another variable. The sample subjected to treatment is known as “experimental units.”
An example of the experimental method is a public clinical trial...
An example of the experimental method is a public clinical trial...
01:16Clinical 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...
01:16Crossover Experiments
Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
01:11Blinding
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.
01:11Clinical 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...
01:15Bioavailability 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,...