Redefining Collaborative Dynamic in Drug Development: Patient Organizations as New Stakeholders for Oncology Clinical Trials in the U.S.

In pharmaceutical development, it has become recognized as important to leverage the voices of patients, the end-users, in addition to existing stakeholders such as pharmaceutical companies and healthcare professionals, in addressing unmet medical needs. This study focused on patient organizations as new stakeholders, especially analyzing environmental factors that encourage their collaboration as sponsors in conducting clinical trials and their relationships with other stakeholders. It analyzes 14,830 cancer-related clinical trials from the ClinicalTrials.gov database, conducted in the U.S. between 2010 and 2020, categorizing them by sponsor types and cancer categories. The research reveals that patient organizations co-sponsored 2<sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">%</sup> of these studies, with a significant number of these collaborations taking place at specific National Cancer Institute (NCI)-designated centers. These patient organization co-sponsored studies often involved specific investigators. Notably, patient organization co-sponsored trials showed a higher proportion of pediatric indications (30%) compared to the overall total (9<sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">%</sup>). The findings highlight that patient organizations are more actively involved in trials focusing on certain cancer types and pediatric populations, areas typically less prioritized by corporate sponsors. The study underscores the crucial role of comprehensive cancer centers and key investigators in facilitating collaborations with patient organizations and in the successful execution of co-sponsored trials.