Conti L, Giovanni B C, Levine J
Int J Clin Pharmacol Res. 1986;6(3):181-7.
Few substantial improvements have been made in the development of detailed and logical methodologies and techniques for analysing, documenting and presenting information acquired during clinical trials on psychotherapeutic agents. This results in a loss of information and makes it impossible to compare or combine data derived from different clinical trials, even on the same drug. We believe that a more extensive utilization of the large amount of data collected in clinical trials may be derived through the use of computerized systems for analysing and documenting such data. With the purpose of studying computer-based data documentation techniques, at the Institute of Clinical Psychiatry of the University of Pisa there has been jointly established by the US National Institute of Mental Health and the University of Pisa a Centre for Clinical Psychopharmacology Data Documentation (CCPDD). The major objective of the CCPDD is to enhance the quality of clinical trials of psychotherapeutic agents by improving computer-based data documentation techniques which allow more understandable, comprehensive, exhaustive and standardized data analysis and data presentation. The CCPDD operates the Biometric Laboratory Information Processing System/Data Bank for Psychopharmacology (BLIPS/DBP), a fully computerized system designed to process any type of assessment data in standardized ways providing the basic documentation for each clinical trial.(ABSTRACT TRUNCATED AT 250 WORDS)
在用于分析、记录和呈现心理治疗药物临床试验中所获取信息的详细且合乎逻辑的方法和技术的开发方面,几乎没有取得实质性进展。这导致了信息的丢失,使得即便对于同一种药物,也无法比较或整合来自不同临床试验的数据。我们认为,通过使用计算机系统来分析和记录此类数据,可以更广泛地利用临床试验中收集到的大量数据。为了研究基于计算机的数据记录技术,美国国立精神卫生研究所与比萨大学在比萨大学临床精神病学研究所联合设立了一个临床精神药理学数据记录中心(CCPDD)。CCPDD的主要目标是通过改进基于计算机的数据记录技术来提高心理治疗药物临床试验的质量,这些技术能够实现更易于理解、全面、详尽且标准化的数据分析和数据呈现。CCPDD运行生物统计学实验室信息处理系统/精神药理学数据库(BLIPS/DBP),这是一个完全计算机化的系统,旨在以标准化方式处理任何类型的评估数据,为每项临床试验提供基本记录。(摘要截选至250词)