Program management challenges of clinical studies: A qualitative critical assessment.

Abstract

Organization, coordination, and discipline are required to complete any intricate operation, conducting a clinical experiment is no different. There are usually many moving components, from designing a plan, to conveying changes, to calculating risk, and excellent project management which are necessary to guarantee the study works successfully. Past evidence suggested that roadblock at any level hampers the progress of the clinical research. Understanding program management challenges hence becomes the key for timely and effective completion of clinical research. A cross-sectional qualitative enquiry involving stakeholders in clinical research program management. We used problem tree-based approach wherein we documented views of various stakeholders to understand the interaction, interdependence, and related interventional needs of bottlenecks for long-term research gains using modern management methods applicable in clinical settings. The best fit approach was also explored to augment maximum benefit in limited resource settings. Non-alignment with state policy aims, a lack of effective coordination and communication among members, challenging logistic management, limited use of technology, a need for training, and an inefficient monitoring mechanism were among the major issues highlighted, and solutions were proposed. Study concludes that an Integrated Process-cum-Timeline-Based Management strategy with multisectoral emphasis is ideal for program management of clinical projects.