利益相关者参与在不断发展的欧盟HTA过程中的作用:
Lauren Van Haesendonck1, Jörg Ruof2,3, Thomas Desmet1,4
1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Journal of market access & health policy
|June 7, 2023
概括
确保利益相关者的参与对于欧盟HTA协调至关重要. 这项研究发现,关键群体认为他们的参与程度低于其他人对他们的评价,这凸显了在欧盟HTA过程中改善参与策略的需要.
科学领域:
- 卫生经济学和结果研究研究.
- 监管科学是一种监管科学.
- 卫生政策 卫生政策
背景情况:
- 欧盟 (欧盟) 卫生技术评估 (HTA) 协调进程需要有效的利益相关者参与才能成功实施.
- 了解各种利益相关者的当前和预期角色对于优化这一过程至关重要.
研究的目的:
- 评估关键利益相关者目前在欧盟HTA框架中的参与程度.
- 确定建议的未来角色,识别挑战,并突出有效的参与方法,利益相关者.
- 将自我感知的参与与来自HTA机构,付款者和决策者的外部评级进行比较.
主要方法:
- 采用多步骤程序,在欧盟HTA框架内,为各种利益相关者开发和传播调查.
- 关键的利益相关者包括患者,临床医生,监管机构代表和健康技术开发商.
- 使用了两种调查版本:主要利益相关者的自我评级和HTA机构,付款人和政策制定者的外部评级. 分析包括预定义的统计和定性评估,导致RACI图表的开发.
主要成果:
- 来自患者,临床医生,监管机构,健康技术开发商,HTA机构,支付者和决策者,共收到54份回复.
- 与外部评级相比,所有关键利益相关者群体的自我参与评分在所有关键利益相关者群体中始终较低.
- 基于调查见解,开发了一个RACI (负责/可问责/咨询/获悉) 图表,以定义在欧盟HTA过程中利益相关者的角色.
结论:
- 需要大量的努力和专门的研究议程,以确保关键利益相关者充分参与不断发展的欧盟HTA协调进程.
- 解决自我感知和外部感知参与之间的差异对于提高利益相关者的贡献至关重要.
- 这些发现为制定有针对性的战略提供了基础,以提高利益相关者的参与度和欧盟HTA协调的整体有效性.
相关概念视频
01:03Drug Control Governance: Regulatory Bodies and Their Impact
196
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
196
01:11Clinical Trials: Overview
3.1K
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...
3.1K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
150
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,...
150
01:30Ethical Dilemmas II
1.2K
Resolving an ethical dilemma in healthcare involves a systematic approach that considers every aspect of the issue, respecting both the patient's needs and values and the healthcare professional's ethical obligations. Here are potential steps to resolve an ethical dilemma:
1.2K
01:28Preclinical Development: Overview
4.5K
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...
4.5K
01:19Standards of Care II
690
Nurses bear specific legal responsibilities under several federal statutes, including:
690