释放潜力:对儿科主协议的系统审查
Yimei Li1,2,3, Robert Nelson4, Rima Izem5
1Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, 3501 Civic Center Blvd, Colket Translational Research Building Room 4032, 19034, Philadelphia, PA, USA. liy3@chop.edu.
Therapeutic innovation & regulatory science
|April 23, 2024
概括
主协议越来越多地用于儿科药物开发,特别是瘤学中的平台和篮子试验. 然而,它们的采用仍然有限,需要进一步研究实施障碍.
科学领域:
- 临床试验 临床试验
- 儿科药理学 儿科药理学
- 药物开发 药物开发
背景情况:
- 主协议提供创新的临床试验设计,增强药物开发的操作和分析.
- 虽然儿科研究已经确立,但新设计的应用,如主协议,尚未得到充分理解.
研究的目的:
- 系统地审查在儿科药物开发中使用主协议的情况.
- 分析趋势并确定儿科研究中常见的主协议类型.
主要方法:
- 在2022年9月进行了一项系统性审查,搜索PubMed和ClinicalTrials.gov的过去10年的研究.
- 提取的数据包括一般的研究信息,儿科特异性,以及随机化和并发对照等设计元素.
主要成果:
- 主协议研究正在被用于儿科,平台和篮子试验比雨试验更为普遍.
- 大多数儿科主协议经验是在瘤学和早期阶段研究中,自2020年以来显著增加,特别是在瘤学和COVID-19试验中.
- 在儿科临床研究中采用主协议目前是有限的,但显示出扩展的潜力.
结论:
- 在儿科药物开发中,主要在瘤学中,正在出现主协议.
- 需要进一步调查,以解决阻碍儿童临床研究中更广泛地实施总体协议的障碍.
相关概念视频
01:26Methods of Documentation II: POMR
944
The Problem-Oriented Medical Record (POMR) revolutionized medical record-keeping by introducing a systematic approach focusing on the patient's problems rather than merely listing symptoms. Dr. Lawrence Weed's introduction of this method in the 1960s marked a significant advancement in medical documentation. The POMR framework consists of four key components: the database, problem list, plan of care, and progress notes.
944
01:15Methods of Documentation VI: Case Management Model
570
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
For example, a patient with a chronic...
570
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
01:26Types of Reports III: Telephone and Verbal Reports
738
Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders
Here's an overview of each type:
Telephone Orders
738
01:19Pharmacovigilance
829
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
829