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用于临床研究试验的石蜡块是否存在释放障碍?美国病理学家学会对 609 个实验室的调查。

Are there barriers to the release of paraffin blocks for clinical research trials? A College of American Pathologists survey of 609 laboratories.

机构信息

Department of Pathology, St Jude Medical Center, Fullerton, California 92835, USA.

出版信息

Arch Pathol Lab Med. 2011 Jul;135(7):870-3. doi: 10.5858/2010-0676-CP.1.

DOI:10.5858/2010-0676-CP.1
PMID:21732776
Abstract

CONTEXT

The number of paraffin blocks submitted for patients enrolled in clinical research trials appears to be declining.

OBJECTIVE

To obtain information on laboratory policies and procedures in complying with requests to submit paraffin blocks for research.

DESIGN

A questionnaire was sent to members of a voluntary market research panel composed of pathologists representing a broad spectrum of experience and practice settings. The questions addressed departmental policies and the likely responses to requests to submit pathology materials for patients enrolled in clinical trials.

RESULTS

The survey was completed by 609 of 762 pathologists (80%) who responded to the invitation. More than 90% of respondents stated that they comply with these requests. Although 14% have a policy precluding the release of blocks for research, 84% of those will send limited tissue samples in lieu of blocks. When tumor is confined to a single block, most laboratories will not release the block but will send unstained slides. Very few laboratories require reimbursement before releasing tissues.

CONCLUSIONS

Pathologists attempt to comply with requests for materials but usually refuse to release the only diagnostic paraffin block so that materials are retained for possible future needs. Other problems identified in this survey include difficulties in getting blocks returned when needed and poor communication between researchers and laboratories. Lack of reimbursement and inadequate consent are not significant barriers to release of materials.

摘要

背景

提交给参与临床研究试验的患者的石蜡块数量似乎正在减少。

目的

了解实验室为满足提交石蜡块进行研究的请求而遵循的政策和程序的信息。

设计

向一个由代表广泛经验和实践环境的病理学家组成的自愿市场研究小组的成员发送了一份问卷。这些问题涉及部门政策以及对提交参与临床试验的患者病理材料的请求的可能反应。

结果

对收到邀请的 762 名病理学家中的 609 名(80%)进行了调查。超过 90%的受访者表示他们遵守这些请求。尽管有 14%的人有禁止发布块用于研究的政策,但其中 84%的人将发送有限的组织样本代替块。当肿瘤局限于单个块时,大多数实验室不会释放块,而是会发送未经染色的幻灯片。很少有实验室在释放组织之前需要报销。

结论

病理学家试图遵守材料请求,但通常拒绝释放唯一的诊断性石蜡块,以便将材料保留用于未来可能的需求。本调查中还发现了其他问题,包括在需要时难以取回块以及研究人员和实验室之间沟通不畅。缺乏报销和同意不足并不是释放材料的重要障碍。

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