现实世界的数据:在癌症临床试验中的应用和相关性
Andrew J Gross1, Courtney E Pisano1, Chachrit Khunsriraksakul2
1University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, OH.
Seminars in radiation oncology
|September 8, 2023
概括
随机对照试验 (RCT) 是比较有效性研究 (CER) 的黄金标准,提供了强有力的证据. 来自国家癌症数据库的现实世界数据 (RWD) 补充了研究癌症流行病学和护理模式的RCT.
科学领域:
- 在瘤学瘤学.
- 医疗保健服务研究 医疗服务研究
- 生物统计学 生物统计学
背景情况:
- 随机对照试验 (RCT) 是比较有效性研究 (CER) 的黄金标准.
- 随着大型国家癌症数据库的日益普及,研究提供了真实世界数据 (RWD).
- 本综述探讨了RCT和RWD在瘤学CER中的作用和局限性.
研究的目的:
- 审查RCT在瘤学比较有效性研究中的确定的作用.
- 评估来自国家癌症数据库的现实数据的实用性和局限性.
- 为了比较RCT与RWD在生成癌症护理可靠证据方面的优缺点.
主要方法:
- 在瘤学中使用RCT和RWD的研究的文献综述.
- 对CER每个数据源的方法论优点和局限性的分析.
- 讨论RWD在流行病学,护理模式和差异等领域的应用.
主要成果:
- 对于CER,RCT是首选的,因为它减少了混和偏差,确保了高的内部有效性.
- 区域实验室面临时间,资源,概括性和外部有效性方面的挑战,可能会排除特定人群.
- RWD对于癌症流行病学,护理模式,差异,质量评估以及评估RCT在被排除在外的群体中的适用性有价值.
结论:
- 由于其严格的设计,RCT仍然是CER中确定因果治疗效果的黄金标准.
- RWD提供了对现实世界癌症护理的补充见解,但在解决因果推断的混方面存在局限性.
- 整合来自RCT和RWD的证据对于全面了解和改善癌症护理至关重要.
更多相关视频
07:42Patient-Derived Tumor Explants As a "Live" Preclinical Platform for Predicting Drug Resistance in Patients
Published on: February 7, 2021
5.0K
07:40Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
16.8K
相关概念视频
01:21Cancer Survival Analysis
381
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...
381
01:16Clinical Trials
6.8K
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...
6.8K
01:11Clinical Trials: Overview
3.0K
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...
3.0K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
147
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,...
147
02:50Combination Therapies and Personalized Medicine
4.9K
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...
4.9K
02:49Cancer Therapies
7.7K
Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
7.7K