Taming clinical research's paper tigers.
Taming clinical research's paper tigers.
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驯服临床研究的纸老虎。
DOI：
10.1158/1078-0432.ccr-06-1095
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发表时间：
2006
期刊：
影响因子：
--
通讯作者：
Gallin,JohnI
中科院分区：
文献类型：
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作者：
Gallin,JohnI
几年前，一位著名的NIH内部医生科学家想要将基础科学观察转化为临床医学，但是从概念到行为的协议所涉及的文书工作是压倒性的。这位沮丧的科学家说：“在《自然》、《科学》或《新英格兰医学杂志》上发表一篇论文比撰写并批准一份协议更容易。”于是，一群校内科学家开始了这段旅程，他们致力于设计工具，以解决与临床研究项目的开发和实施相关的复杂且经常令人困惑的文书工作。通过驯服官僚文书工作（或繁文缛节）的纸老虎，这些工具可以帮助创建一个更安全，更高效，管理更好的临床研究企业。最终目标是一个工具，Prototype，我们正在从头开始构建。Prototype的愿景是促进方案编写和审查、研究新药表格的归档、患者招募、资源预测和知情同意过程。它还将跟踪协议活动，生成早期毒性警报，启动不良事件报告，并自动向转诊医生发送里程碑信件。该工具的某些部分已经完成;其他部分正在开发或将在其他地方开发。主要完成的组件是协议编写。该组件具有标准格式，包括简介、引言、背景、研究设计、患者入组、研究分析、不良事件/数据安全性监测计划、人类受试者保护、药理学和器械信息、参考文献和结构化知情同意书。整个工具都是学习门户，可以访问有关如何使用资源的详细信息以及历史和当前参考资料的链接。机构审查委员会推荐的最新语言的病例可以被拖到方案中并放置在适当的部分，这一功能在撰写同意书时特别有用。甚至可以根据特定的机构审查委员会的要求定制一个协议（NIH有14个机构审查委员会）。协议作者可以创建一个与自己的协议组合最相关的语言盒和图形库，建立一个可以存储并拖到未来协议中的图像集合，将政策和法规更新集成到协议中。Prototype的参考文献管理器可以轻松连接到PubMed，自动重新编号参考文献，并方便将参考文献从一个协议迁移到另一个协议。研究性新药向导允许研究者根据美国食品药品监督管理局提供的信息制定的问题，决定是否需要提交研究性新药表格。一旦编写了方案，就可以很容易地以电子方式将文件发送给所需的审查小组。在美国国立卫生研究院，一项研究方案要经过许多机构的独立审查，包括科学质量、伦理、机构审查委员会和资源要求。审查官员的电子签名是标准作业程序。
Several years ago, a prominent NIH intramural physicianscientist wanted to translate basic science observations to clinical medicine, but the paperwork involved in taking a protocol from concept to conduct was overwhelming.‘‘It was easier to get a paper published in Nature, Science, or The New England Journal of Medicine than to get a protocol written and approved,’’said the frustrated scientist. So began the journey by a group of intramural scientists, a quest dedicated to designing tools that could cut through the complex and often confusing paperwork associated with the development and implementation of clinical research projects. By taming the literal paper tiger of bureaucratic paperwork (or red tape), these tools can help create a clinical research enterprise that is safer, more efficient, and better managed. The ultimate goal is a tool, ProtoType, which we are building from scratch. The vision is that ProtoType will facilitate protocol writing and review, filing of investigational new drug forms, patient recruitment, resource projections, and the informed consent process. It also will track protocol activity, generate early toxicity alerts, initiate adverse event reports, and automate milestone letters to referring physicians. Some portions of the tool are complete; others are under development or will be developed elsewhere. The major completed component is protocol authoring. This component has a standard format that comprises a précis, an introduction, background, study design, patient enrollment, study analysis, adverse event/data safety monitoring plan, human subjects protection, pharmacologic and device information, references, and structured informed consent forms. Throughout the tool are learning portals for access to details on how to use the resource and links to historical and current references. Cassettes with the most up-to-date language recommended by institutional review boards can be dragged into the protocol and placed in appropriate sections, a feature particularly helpful when writing consent forms. It’s even possible to tailor a protocol to specific institutional review board requirements (there are 14 institutional review boards at the NIH). Protocol authors can create a library of language cassettes and figures most pertinent to their own portfolio of protocols, build a collection of images that can be stored and dragged into future protocols, integrate policy and regulatory updates into the protocol.ProtoType’s reference manager enables easy connection to PubMed, automatically renumbers references, and facilitates migration of references from one protocol to another. An investigational new drug wizard allows the investigator to decide, based on questions developed with input from the Food and Drug Administration, on the necessity of filing an investigational new drug form. Once the protocol is written, it is easy to send the document electronically to the required review groups. At the NIH, a protocol undergoes independent reviews by numerous bodies for scientific quality, ethics, and institutional review board and resource requirements. Electronic signatures by the reviewing officials are standard operating procedure.