The current state of understanding of oncology expanded access programs in Malaysia.

Q3 Medicine Medical Journal of Malaysia Pub Date : 2024-03-01

F L Yong, W C Tan

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引用次数: 0

Abstract

Introduction: An expanded access program (EAP) is a regulatory mechanism that provides access to an investigational drug, which is not approved for use, in treating life-threatening conditions when all the standard-ofcare treatments are exhausted.

Materials and methods: An online, anonymous, voluntary survey was conducted to assess the level of knowledge and understanding about EAPs among Malaysian oncologists using SurveyMonkey® between April 2020 and June 2020. Oncologists who had enquired about EAP in the past, were invited at random to participate in the survey. Participants who did not provide consent or failed to complete the survey were excluded.

Results: A total of 15 oncologists participated in the survey, from both public (46.6%) and private (46.6%) practices. Most respondents (80%) had filed between 1 to 10 EAP applications in the past 12 months. For 73.3% respondents, resources or training were not provided for EAPs from institutions. Around 53% of the respondents reported that their knowledge of EAPs and application processes including country regulations is 'good'. The majority of respondents (73.3%) reported that the educational modules on an overview of EAPs, country regulations and the EAP application process will be beneficial. Most participants received information about the existing EAPs either by reaching out to a pharmaceutical sponsor or through another health care provider and some received information about the existing EAPs through their institutions or patients/caregivers. Most of the respondents recommended that pharmaceutical companies should have readily available information related to the availability and application of EAPs for all pipeline products on their websites.

Discussion: EAPs are crucial treatment access pathways to provide investigational drugs to patients who have exhausted their treatment options and are not eligible for participation in clinical trials. Malaysian oncologists have a fair understanding about the EAPs and the application processes.

Conclusion: Additional training and awareness are needed for Malaysian oncologists to upscale the utilisation of EAPs.

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马来西亚对肿瘤扩大治疗计划的认识现状。

简介：扩大准入计划（EAP）是一种监管机制，在用尽所有标准治疗方法的情况下，为治疗危及生命的疾病提供未经批准使用的研究药物：在 2020 年 4 月至 2020 年 6 月期间，使用 SurveyMonkey® 进行了一项在线、匿名、自愿调查，以评估马来西亚肿瘤学家对紧急医疗援助计划的了解和理解程度。随机邀请过去曾询问过 EAP 的肿瘤学家参与调查。未经同意或未能完成调查的参与者将被排除在外：共有 15 名肿瘤学家参与了调查，他们分别来自公立（46.6%）和私立（46.6%）医疗机构。大多数受访者（80%）在过去 12 个月中提交过 1 到 10 份 EAP 申请。73.3%的受访者表示，机构没有为 EAP 提供资源或培训。约 53%的受访者表示，他们对 EAP 和申请程序（包括国家法规）的了解程度为 "良好"。大多数受访者（73.3%）表示，关于 EAPs 概述、国家法规和 EAP 申请程序的教育模块将有所助益。大多数参与者是通过联系制药赞助商或其他医疗服务提供者获得有关现有 EAP 的信息，还有一些人是通过其所在机构或患者/护理人员获得有关现有 EAP 的信息。大多数受访者建议，制药公司应在其网站上随时提供有关所有在研产品的 EAPs 可用性和应用情况的信息：EAP是为已用尽治疗方案且不符合参与临床试验条件的患者提供研究药物的重要治疗途径。马来西亚的肿瘤学家对EAPs和申请流程有一定的了解：马来西亚肿瘤学家需要接受更多培训，提高对EAPs的认识，以扩大EAPs的使用范围。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Medical Journal of Malaysia Medicine-Medicine (all)

CiteScore

1.20

自引率

0.00%

发文量

165

期刊介绍： Published since 1890 this journal originated as the Journal of the Straits Medical Association. With the formation of the Malaysian Medical Association (MMA), the Journal became the official organ, supervised by an editorial board. Some of the early Hon. Editors were Mr. H.M. McGladdery (1960 - 1964), Dr. A.A. Sandosham (1965 - 1977), Prof. Paul C.Y. Chen (1977 - 1987). It is a scientific journal, published quarterly and can be found in medical libraries in many parts of the world. The Journal also enjoys the status of being listed in the Index Medicus, the internationally accepted reference index of medical journals. The editorial columns often reflect the Association''s views and attitudes towards medical problems in the country. The MJM aims to be a peer reviewed scientific journal of the highest quality. We want to ensure that whatever data is published is true and any opinion expressed important to medical science. We believe being Malaysian is our unique niche; our priority will be for scientific knowledge about diseases found in Malaysia and for the practice of medicine in Malaysia. The MJM will archive knowledge about the changing pattern of human diseases and our endeavours to overcome them. It will also document how medicine develops as a profession in the nation. We will communicate and co-operate with other scientific journals in Malaysia. We seek articles that are of educational value to doctors. We will consider all unsolicited articles submitted to the journal and will commission distinguished Malaysians to write relevant review articles. We want to help doctors make better decisions and be good at judging the value of scientific data. We want to help doctors write better, to be articulate and precise.