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Clinical Trials01:16

Clinical Trials

10.1K
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...
10.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.5K
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...
4.5K
Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.7K
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

848
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...
848
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

380
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,...
380
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.1K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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関連する実験動画

Updated: Jan 8, 2026

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

Published on: September 20, 2019

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スペインにおける低介入臨床試験：進捗しているか？

Claudia Erika Delgado-Espinoza1,2,3, Mayro J Cortés Pestana1,2,3, Kristopher Amaro1,2,3

  • 1Department of Pharmacology and Therapeutics, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.

British journal of clinical pharmacology
|December 17, 2025
PubMed
まとめ

スペインにおける低介入臨床試験（LICT）は、依然として研究全体のわずかな割合を占めており、主に非商業的で承認済み薬剤を評価している。そのデザインはより堅牢になる可能性があるが、最近の規制変更はLICT活動に影響を与えていない。

キーワード:
臨床試験低介入臨床試験非商業的臨床研究規制

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Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
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関連する実験動画

Last Updated: Jan 8, 2026

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E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
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科学分野:

  • 臨床薬理学; 規制科学; ヘルスサービスリサーチ

背景:

  • 低介入臨床試験（LICT）は、承認済み医薬品の実践的な研究である。非商業的臨床試験（NCCT）を支援するために2014年に簡略化された規制が導入された。2023年の臨床試験情報システム（CTIS）の実装は、LICTの実現可能性に影響を与える可能性がある。

研究 の 目的:

  • 2014年から2023年にスペインで承認されたLICTの特性を記述すること。規制変更とCTISがLICTに与える影響を評価すること。

主な方法:

  • LICTの横断記述的分析。スペイン臨床試験登録（REec）（2014-2023）からのデータソース。

主要な成果:

  • LICTは全試験登録の3.8%（322/8497）を占めた。ほとんどのLICTは非商業的にスポンサーされ、第IV相、単施設で、承認済み薬剤を評価した。有効性/安全性は主な目的であり、薬経済学と生物学的同等性はまれであった。デザインはしばしばランダム化されたが、盲検化またはプラセボ対照はまれであった。

結論:

  • LICTは実世界のエビデンスにとって重要であるが、スペインの試験全体では依然として少数である。LICTのデザインは、堅牢性の点で改善の余地がある。CTISの実装は、2023年のLICT活動に影響を与えなかったようである。