Academic vs. industry-sponsored trials: A global survey on differences, similarities, and future improvements.

Abstract

Background: Clinical research is marked by its multifaceted nature, presenting a multitude of different approaches, designs, and objectives that can complicate the planning, initiation, and conduct of clinical trials. The role and organisation of the sponsor institution are pivotal in this context. We aimed to investigate possible challenges and needs, including their underlying factors, for academia and industry during the set-up and conduct of clinical trials.

Methods: We conducted a cross-sectional survey-based study within an international network of highly qualified academic research institutions (ARIs). The main outcome measures were the regulatory framework for clinical trials, scope and organisation of academic and industry-sponsored trials, funding sources of academic clinical trials, submission and approval process, as well as study conduct of academic vs. industry-sponsored trials.

Results: We surveyed employees of ARIs with extensive experience in phase I-IV clinical trials. All ARIs participated in academic clinical trials and 90% were involved in industry-sponsored trials. Respondents reported that academic trials faced greater challenges in communication with relevant institutional review boards/ethics committees and competent authorities compared to industry-sponsored trials. Additionally, academic trials were found to have significantly less financial support during their conduct. Specific challenges for academia vs. industry included 'insufficient personnel resources' (60% vs. 50%), 'recruitment problems' (60% vs. 78%) and 'lack of knowledge/experience' (35% vs. 11%).

Conclusions: Our findings indicate that industry-sponsored trials encounter fewer issues in set-up, funding, and trial conduct compared to academic trials. Improving collaboration between academic sponsors and ARIs is essential to address these challenges. ARIs provide critical support and guidance for academic researchers, not only in planning and implementing projects, but also in assessing feasibility and securing funding.