Factors that could potentially impact on the initiation time of oncology clinical trials at investigational sites

Abstract

Abstract Background Clinical Research Organizations (CROs) have been required to ensure delivery of expertise and high-quality services and promptly conduct a clinical trial. Shortening the duration of a clinical trial is considered to have a great impact on the development of pharmaceutical products. IQVIA reported last year that the period to initiate a clinical trial was related to the number of clinical trials conducted by the sites, the Clinical Trial Office staff and the method to shorten the initiation period. IQVIA has previously reported that explored in detail factors that could have an impact on the initiation time. Method In this study, the Clinical Trial Management System (CTMS) of IQVIA was used to select 126 sites that have clinical trials experience with IQVIA that have conducted clinical trials with the company. A web-based questionnaire was sent out to a total of 378 clinical trial physicians, study coordinators and the Clinical Trial Office staff. As a result, 224 or 60% of the surveyed people responded to the questionnaire from January to February 2019. Factors that could influence on the study initiation period were then analyzed based on the results of the questionnaire and the data of the IQVIA’s CTMS. The sites that could not be identified in the questionnaires were excluded from the analysis. Results Of the factors that could influence the initiation period, the following were highlighted as particularly significant: duties involving clinical trial contracts, experience in inspection, training-related tasks and the number of clinical trials conducted by the sites. The results revealed that the number of clinical trials conducted by the sites influenced the initiation period as previously considered.