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临床试验中参与者的招募与留存:挑战与解决方案。

Recruitment and retention of the participants in clinical trials: Challenges and solutions.

作者信息

Chaudhari Nayan, Ravi Renju, Gogtay Nithya J, Thatte Urmila M

机构信息

Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.

出版信息

Perspect Clin Res. 2020 Apr-Jun;11(2):64-69. doi: 10.4103/picr.PICR_206_19. Epub 2020 May 6.

Abstract

Drug development is a tedious and expensive procedure and it takes roughly 10 to 15 years to take a potential treatment from bench to bedside and costs the pharmaceutical companies as much as USD ~2 billion for the process. Delay in investigator-initiated studies can cause financial loss to grant providers (either public or private) and investigator's reputation may also be at stake. Participant recruitment and retention are two major bottlenecks in conducting clinical trials and contribute vastly to the delays. They are essential for both scientific validity of the clinical study and economic reasons. Thus, issues in recruitment and retention should be addressed and minimized. A proper recruitment and retention plan incorporating adequate communication between all stakeholders will eventually avoid the delays in drug development and make treatments available to the consumer at an earlier date and at a more affordable price. Awareness of challenges and reviewing strategies that can optimise recruitment and retention will facilitate drug development. The article gives a first-person perspective on challenges and proposed solutions from an experienced clinical study centre in a tertiary care hospital.

摘要

药物研发是一个冗长且昂贵的过程,从实验室研究到临床应用大约需要10到15年时间,制药公司在此过程中的花费高达约20亿美元。研究者发起的研究出现延迟会给资助机构(无论是公共的还是私人的)造成经济损失,研究者的声誉也可能受到影响。受试者的招募和留存是开展临床试验的两大主要瓶颈,也是导致延迟的主要原因。这对于临床研究的科学有效性和经济因素而言都至关重要。因此,应解决并尽量减少招募和留存方面的问题。一个合适的招募和留存计划,包括所有利益相关者之间充分的沟通,最终将避免药物研发的延迟,并使消费者能够更早且以更实惠的价格获得治疗。认识到挑战并审视能够优化招募和留存的策略将有助于药物研发。本文从一家三级护理医院经验丰富的临床研究中心的第一人称视角阐述了挑战及提出的解决方案。

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