Tools to optimize the functionality of a leukemia clinical trial team.

A multidisciplinary approach offers efficiency and quality care by delegating tasks according to individuals' expertise. However, increasingly stringent regulatory requirements, albeit essential for successful conduct of clinical trials, have magnified the workload of research teams. We describe tools that have efficiently addressed regulatory requirements and facilitated the conduct of clinical trials. The research team consisted of a merge of healthcare providers and research staff. Each individual team consisted of a hematologist, a physician assistant and a nurse coordinator, supported by a shared group of clinical research coordinators, an investigational drug pharmacist, a regulatory associate and a data manager. Technology tools, complemented by operational reorganization, optimized knowledge, documentation and communication, and allowed high volume enrollment with consistent regulatory compliance. We conclude that technology combined with a coordinated team care approach can facilitate the integration of trials in clinical practice.