STORAGE MANAGEMENT OF CLINICAL RESEARCH SUPPLIES OF A PHASE IIB/III, NATIONAL, MULTI-CENTRE, DOUBLE-BLIND AND RANDOMIZED STUDY
Abstract: New drugs suffer a long and slow proceeding to reach the market. On the one hand there are difficulties from the regulatory agency that delays the onset of clinical trial studies, on the other hand there is a slow patient recruitment during the course of the trial that prevents its completion. An efficient management of clinical trial supplies throughout the supply chain is essential. Thus, the objective of this study was to characterize the clinical supplies storage management in a national, multi-centre, double-blind and randomized study to evaluate the efficiency and safety of a combination of drugs to treat acute pain. The study was primarily focused on storage conditions of clinical supplies, detailing their distribution to the research sites. According to the data observed in this study, the clinical supplies storage management was not determinant for the slow patient recruitment process that reflected the delay to the end of the study. And although the centers were located in different states, there were no delays, loss or damage during storage and distribution that could compromise the proper stock and storage management of clinical trial supplies.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors must have a written permission from any third-party materials used in the article, such as figures and graphics. The permission must explicitly allow authors to use the materials. The permission should be submitted with the article, as a supplementary file.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) after BJO&PM publishes it (See The Effect of Open Access).