产品开发伙伴关系,制药行业和研究人员启动的临床试验之间的操作差异
Eric I Nebie1,2,3, Peter van Eeuwijk1,4, Hélène N Sawadogo3
1Swiss Tropical and Public Health Institute, Kreuzstrasse 2, CH-4123 Allschwil, Switzerland.
Tropical medicine and infectious disease
|March 27, 2024
概括
优化临床研究效率需要了解药物,合作伙伴关系和研究者发起的试验之间的操作差异. 早期的现场参与和量身定制的质量方法是改善临床操作性能的关键驱动因素.
科学领域:
- 临床研究操作临床研究操作
- 药物开发效率 药物开发效率
- 医疗保健管理的管理
背景情况:
- 药物开发是一个漫长,复杂的过程,监管要求越来越高.
- 试验复杂度的增加可能导致药物开发效率下降,产量下降和成本上升.
- 临床试验的替代操作模式存在于传统的药品赞助之外.
研究的目的:
- 为了比较制药行业赞助的试验,产品开发伙伴关系试验和研究人员发起的试验之间的操作差异.
- 确定临床研究操作中低效率的关键驱动因素.
- 探索提高临床试验性能和减少过程负担的潜在策略.
主要方法:
- 一个探索性的混合方法研究,涉及利益相关者:临床试验赞助商,合同研究组织 (CRO) 和研究人员.
- 在布基纳法索,马里和瑞士,通过40次半结构面试,12次研究文档审查和工作影像收集定性数据.
- 通过对临床研究专业人员的在线调查进行定量数据三角化.
主要成果:
- 运营差异被分类为试验启动,研究复杂性,现场结构,研究进行/质量和现场能力加强.
- 早期参与规划和定制质量方法被确定为临床操作绩效的关键.
- 在试验类型之间观察到规划,操作复杂性,质量管理和现场支持方面的差异.
结论:
- 整合质量设计原则可能会减少临床研究中不必要的过程负担.
- 定制的运营策略和早期利益相关者参与对于提高临床试验效率至关重要.
- 了解和解决不同试验赞助模式之间的运营差异可以提高药物开发结果.
相关概念视频
01:11Clinical Trials: Overview
2.9K
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...
2.9K
01:28Preclinical Development: Overview
4.4K
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...
4.4K
01:16Clinical Trials
6.7K
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...
6.7K
01:26Drug Administration and Therapy Phases: Overview
457
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...
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...
457
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
126
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,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
126
01:26Drug Discovery: Overview
7.9K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
7.9K