THOUGHT LEADERSHIP

Most clinical researchers are motivated by the desire to improve patient health and drive innovation in healthcare. To optimize health system performance, Bodenheimer and Sinsky, building on the work of Donald Berwick, proposed the quadruple aim as a means to improve health system performance. The quadruple aim focuses on (1) enhancing the patient experience, (2) improving population health, (3) reducing costs, and (4) improving the work life of health care providers, including clinicians and staff. Clinical research should follow the quadruple aim to improve the design and conduct of clinical trials.

As a Clinical Project Manager (CPM), one of my primary roles on a project is to ensure that the clinical and data management stakeholders have the tools necessary to streamline safety review and data quality review on a project. The CPM’s first action should be to complete a Stakeholder Analysis. According to the Project Management Body of Knowledge (PMBOK), Fifth Edition, released by the Project Management Institute (PMI), the key processes in Stakeholder Management are:     
                                                     1. Identify Stakeholders
                                                     2. Plan Stakeholder Management
                                                     3. Manage Stakeholder Engagement
                                                     4. Control Stakeholder Engagement
Knowing who the stakeholders are, and how and when to engage them in the development process of a clinical application, can lead to major improvements in product usability and ultimate project success.