Santoro Eugenio, Rossi Valentina, Pandolfini Chiara, Bonati Maurizio
Laboratory of Medical Informatics, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Clin Trials. 2006;3(4):366-75. doi: 10.1177/1740774506069154.
The need to register a clinical trial in a public database has been widely discussed in the last few years. Several general clinical trial registers have been developed, but none are dedicated to children. A web-based register of trials on drug therapy in children was therefore developed.
The general objective of the project, called DEC-NET (European register of clinical trials on medicines for children - drug evaluation in children) and supported by the European Community, is to provide the scientific community with a flexible tool for promoting communication and collaboration among researchers, disseminating clinical trial results and facilitating patient access and recruitment to trials.
We identified a set of trial data to be collected, including general trial information, recruitment information, eligibility criteria, clinical trial characteristics, location and contact information, study drugs, study sponsor and results. The system was set up to allow authorized users (working in Italy, Spain, France and UK) to enter, handle and monitor the trial information. Medical data dictionaries (ie, ICD-9 and ATC) were used in order to make the data-entry and the search and data analysis procedures easier. A multilingual approach in data handling and presentation made accessing trial information in English and in the language of the country where the study is located feasible. Search and browsing tools were set up to allow investigators, researchers, and citizens to freely search and browse the entire register and access the details of trials meeting the search criteria.
The DEC-net register (http://www.dec-net.org) was opened for trial notification and consultation.
DEC-net currently involves four European countries and is a pilot project.
It is hoped that what has been achieved so far represents only the beginning of a long-term project, and the next step will be to extend the register's use to other European countries.
在过去几年中，关于在公共数据库中注册临床试验的必要性已得到广泛讨论。已经开发了几个通用的临床试验注册库，但没有一个是专门针对儿童的。因此，开发了一个基于网络的儿童药物治疗试验注册库。
该项目名为DEC-NET（欧洲儿童药物临床试验注册库——儿童药物评估），由欧洲共同体支持，其总体目标是为科学界提供一个灵活的工具，以促进研究人员之间的交流与合作，传播临床试验结果，并便于患者参与试验和招募。
我们确定了一组要收集的试验数据，包括试验一般信息、招募信息、入选标准、临床试验特征、地点和联系信息、研究药物、研究赞助商和结果。该系统的设置允许授权用户（在意大利、西班牙、法国和英国工作）输入、处理和监测试验信息。使用医学数据字典（即ICD-9和ATC）以便使数据录入、搜索和数据分析程序更简便。在数据处理和呈现方面采用多语言方法，使得能够以英语以及研究所在国家的语言访问试验信息。设置了搜索和浏览工具，以便研究人员、调查人员和公民能够自由搜索和浏览整个注册库，并获取符合搜索标准的试验详情。
DEC-net注册库（http://www.dec-net.org）已开放用于试验通知和咨询。
DEC-net目前涉及四个欧洲国家，是一个试点项目。
希望目前所取得的成果仅仅是一个长期项目的开端，下一步将是把注册库的使用扩展到其他欧洲国家。
