Abstract
ABSTRACTBackground & objectivesThe study had two aims. 1) Analysis of research projects done in our institution from 2014-2019 to identify products with a potential for commercialization and 2) To understand the effect of product-development variables on research projects to improve the quality of future commercialization-oriented trials.Methods338 clinical trials were grouped into 188 projects under the headings irrigants, diagnostic devices, surgical devices, biomaterials and gels. Trials per project, capital, material costs, labour and the cycle timespertrial were calculated. To understand the effect these variables, five hypotheses were generated to test whether greater number of trials, successes, higher capital, more investigators per trial and a longer trial duration will result in a product worthy of commercialization.Results22 projects had products with a potential for commercialization. Except labour and cycle time (p>0.05), all variables showed significant differences across all projects. Three products were identified as having potential for actual commercialization. It was observed that greater number of trials (χ2=4.6793; p=0.030528) and successes (χ2=20.8134; p<0.00001) in a project along with a higher capital (χ2=12.2662; p=0.000461) will generate a product worthy of commercialization.Interpretation & conclusionsThe results seem to suggest that in trials for commercialization, emphasis must be placed on implementing multiple, well-designed clinical trials on a device or product to successfully identify whether it is commercialization-worthy or not. Due attention must be given to the financial aspects of the projects as deficiencies may result in negative impact on the flow and outcomes of a clinical trial.
Publisher
Cold Spring Harbor Laboratory