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一般医学雑誌に掲載されている治験報告の議論セクション
Mike Clarke1, Phil Alderson, Iain Chalmers
1UK Cochrane Centre, National Health Service Research and Development Programme, Summertown Pavilion, Middle Way, Oxford OX2 7LG, England. mclarke@cochrane.co.uk
JAMA
|June 1, 2002
まとめ
制御試験の結果の解釈には,同様の研究からの文脈が必要です. 2001年の研究では,主要な医学雑誌の報告は,既存のシステマティック・レビューと並行して,新しい発見について議論することに失敗し,1997年以降の進展を示していないことが判明しました.
科学分野:
- 医学研究方法論 医学研究方法論
- 根拠に基づいた医学は,証拠に基づいた医療です.
- クリニック・トライアル・レポート
背景:
- コントロール試験の結果の解釈には,既存の研究との文脈化が必要である.
- 1997年の以前の研究では,この文脈化における欠陥が特定されました.
- この研究では,進捗状況を評価するために同じジャーナルを再評価しました.
研究 の 目的:
- 制御試験の報告が,他の制御試験からの証拠の総和を考慮して,新しい結果について議論する程度を評価する.
- 1997年から2001年の間に試験結果の文脈化が改善されたかどうかを判断する.
主な方法:
- 33件のランダム化試験報告の議論セクションの分析.
- 2001年5月に5つの主要な一般医学雑誌に掲載されました.
- 結果は,1997年5月の同様の評価と比較した.
主要な成果:
- 新しい研究問題を論じた報告書は3つしかなかった.
- 残りの30件の報告のうち,新しい試験結果と更新されたシステマティック・レビューを統合したものはありませんでした.
- 27の報告では,事前の証拠に含まれる発見を文脈化するための体系的な努力が示されていない.
結論:
- 1997年から2001年の間に改善は認められなかった.
- 一般医学雑誌の報告では,最新のシステマティックレビューの文脈で,新しい試験結果について十分に議論されませんでした.
関連する概念動画
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...
01:11Clinical 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...
01:19Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:23Types 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...
01:23Toxicity Testing in Animals
Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
01:12Hazard Ratio
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 evaluating a...
For example, in a clinical trial evaluating a...