在炎症和免疫学中制定总体协议和其他创新的试验设计,以加快临床药物开发
Elena Peeva1, Anindita Banerjee1, Christopher Banfield1
1Pfizer Inc., 1 Portland St, Cambridge, MA 02139, USA.
Drug discovery today
|March 9, 2024
概括
主协议设计,如雨和篮子研究,现在用于炎症和免疫学试验. 这些创新方法为患者提供了成本节约和更快的药物开发.
科学领域:
- 临床试验的设计
- 药理学 药理学是指药理学的学科.
- 免疫学 免疫学 免疫学
背景情况:
- 在瘤学中建立了总体协议设计,包括和篮子研究.
- 这些设计允许在一项研究中同时评估多种化合物或患者群体.
- 传统的随机对照试验可能是资源密集型和耗时的.
研究的目的:
- 探索超越瘤学的主协议设计的应用.
- 详细介绍瑞在炎症和免疫学研究中对这些设计的实施.
- 突出潜在的好处,如节省成本和加快时间表.
主要方法:
- 审查瑞公司最近使用主协议设计的临床研究.
- 专注于在炎症和免疫学治疗领域的实施.
- 分析成本和资源优化机会.
主要成果:
- 证明总体协议设计在非瘤学环境中的适用性.
- 确定显著的成本和资源效率.
- 有证据表明,新疗法评估的时间表已加快.
结论:
- 主协议设计为炎症和免疫学中的传统试验设计提供了可行的和有益的替代方案.
- 这些设计可以加速向患者提供新型治疗方法.
- 瑞的经验展示了实施主协议的实际优势.
相关概念视频
Clinical 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
Preclinical 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
Inflammatory Bowel Disease IV: Pharmacological Management
127
Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
Pharmacologic...
Pharmacologic...
127
Clinical 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
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
163
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
163
Drug 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


