Towards a framework of success factors for clinical trials

Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature has extensively investigated success factors in R&D projects, it has not directly addressed success factors in clinical trials, as the late testing stage of a NPD yet. The aim of this paper is to enhance our understanding of the clinical trial management by creating a new conceptual framework of success factors. This paper creates the new framework by combining success factors from NPD literature and from empirical evidence collected through 11 semi-structured interviews with experts in clinical trials. The framework of success factors provides managerial guidelines for practitioners to optimize clinical trials reducing failures and increasing profits. The framework directs managerial focus on the most important factors for success and helps managers in decision-making of operational tasks. The framework can also be applied as a checklist for assessing the status of a clinical trial and later as a benchmarking tool to compare clinical trial processes. Dependencies among the identified factors seem to exist, thus a set of propositions, can be developed from the success factors and be the basis for future empirical testing.