Overcoming inefficiencies in clinical research by fostering a systems approach and core competencies for biomedical professionals involved in medicines development

Abstract

Clinical trials constitute the largest single component in medicines development, representing nearly 40 % of the related expenses. However, there is broad agreement that the current clinical trial system is inefficient. The biopharmaceutical industry, governments, regulatory agencies, academic researchers, the medical profession, and the media should work collaboratively and create efficient clinical trial networks. Clinical Research in Medicines Development (CR/MD) can be defined as an open system involving the above- mentioned stakeholders interconnected through a series of processes aimed to bring effective and safe medicines into the market. A systems approach is needed to overcome the current barriers to a cost/effective process including appropriate risk management. A simple conceptual model of an integrated system is proposed. The obstacles to implementation are also discussed. Lack of an appropriately trained multi-professional workforce both in the industry-related and the academic clinical research field is also a significant part of the problem. The root of the problem resides in the lack of proper education in CR/MD at the undergraduate and postgraduate levels among academic institutions. Competency-based education has been proposed as a model for improving the quality and accountability for specific functions involved in the drug development process. Despite the growing awareness of competency- based education and the need for implementation of systems-thinking, its full adoption is still far on the horizon. Resistance to change is one of the obstacles to overcome. Continuing efforts to creating further awareness are key responsibilities of professional associations and academic institutions involved in CR/MD.