利用患者报告的结果措施,在早期癌症试验中选择最佳剂量
Bill Byrom1, Anthony Everhart1, Paul Cordero2
1Science and Medicine, Signant Health, 785 Arbor Way, Blue Bell, PA, 19422, United States, 44 20 4526 1340.
JMIR cancer
|February 28, 2025
概括
患者报告的结果对于早期瘤学试验至关重要,以了解剂量毒性并选择最佳药物剂量. 这篇论文主张在早期药物开发中将它们纳入并收集电子数据.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 患者报告的结果
背景情况:
- 患者报告结果测量 (PROM) 是第三阶段试验的标准,但在早期阶段研究中未得到充分利用.
- 患者的观点对于评估剂量毒性和确定最佳药物剂量至关重要.
- 早期瘤学药物开发往往缺乏全面的患者报告数据.
研究的目的:
- 审查将患者报告的结果数据纳入早期瘤学试验的理由.
- 概述在早期瘤学中收集患者报告的结果数据的实际方法.
- 讨论电子数据收集对患者报告结果的好处.
主要方法:
- 这是一篇观点论文,而不是一项初级研究.
- 它包括对早期瘤学的PROM进行现有文献和专家意见的审查.
- 讨论重点是PROMs的战略实施.
主要成果:
- 早期阶段的试验可以从患者报告的结果数据中显著受益.
- 整合PROM有助于更全面地了解剂量限制性毒性.
- 电子数据捕获为PROMs提供了效率和更好的数据质量.
结论:
- 患者报告的结果应在早期瘤学试验中系统地收集.
- 患者的经验提供了超越传统临床评估的关键见解.
- 电子方法提高了在药物开发早期收集患者报告的结果数据的可行性和价值.
相关概念视频
Clinical Trials: Overview
2.7K
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...
2.7K
Combination Therapies and Personalized Medicine
4.8K
Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
4.8K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
111
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,...
111
Cancer Survival Analysis
319
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
319
Clinical Trials
6.6K
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...
6.6K


