Collaboration in research protocol design: A case study exploring knowledge creation for the pharmaceutical industry and prescribing physicians

The pharmaceutical industry is under increasing pressure to bring innovative products to market in a timely manner. Without access to information from people outside the industry, this task is more difficult. Because physicians may have a greater understanding of specific product benefits in a clinical setting, knowledge creation within the pharmaceutical industry can be facilitated through active physician participation in clinical trial design, thereby delivering more effective use of medicines. Ultimately, knowledge creation efforts may enhance the use of evidence-based decision making and improve professional practice, which in turn will promote innovation in service and product development. The study aims to examine the potential for knowledge creation through collaboration between physicians and industry representatives. Eight physicians specialising in a specific disease agreed to meet with three industry representatives who organise clinical trials. The primary endpoint for this study was to design a phase IV clinical trial with collaborating physicians that specifically addressed a medical need within a highly specialised area of medicine. After meeting with industry representatives, the physicians concluded that company-sponsored studies were not appropriate, and any potential research should be conducted on a small scale (pilot and exploratory) within a clinical setting. The collaboration formed in this study failed to produce the intended result of a phase IV research protocol. Physicians were, however, able to steer the industry representatives towards research sponsorship that would – in their opinion – best serve the interests of improved patient outcomes. These findings support the importance of knowledge creation through collaboration between physicians and pharmaceutical companies.