Clinical Research Stakeholder Perceptions of Protectors Against Misconduct: Developing a Sponsor Qualification Tool

Abstract

The clinical research industry involves multiple entities working to provide evidence that hopes to bring new treatments that benefit the general public. Each entity has their respective goals to navigate and contributions to ensure that research subjects are safe during their participation in clinical trials. In the history of clinical research, there have been reports of research misconduct, where the interests of the participants were not of the utmost priority. The government has created new regulations and institutions have implemented procedures to ensure that risks of misconduct are mitigated. The author examined the connection between stakeholders involved in the clinical research enterprise, and their respective roles and goals. These stakeholders include the sponsor, contract research organizations, principal investigators, and the research institution. At the center of the complementary entities are the patients that put their trust in the clinical research system to give themselves hope and contribute to and advocate for clinical research. Adult oncology Principal Investigators, Leaders, and Research Staff at the author’s community hospital research practice graciously contributed to the conduct of this Capstone Project by completing a questionnaire assessing their needs and perceptions. There were areas identified for further investment within the institution’s clinical research infrastructure. The author offered operational enhancements for the institution to implement and created a Sponsor Qualification Tool that will empower clinical research sites to determine if a sponsor and CRO are suitable for a productive and symbiotic partnership.