Harmonizing interactions between clinical trial sponsors and study research sites: An appraisal of the key challenges and recommendations for addressing them.

Successful completion of industry-sponsored clinical trials requires effective collaboration between sponsors and clinical research sites recruiting patients. As pharmaceutical companies specialize in more therapy areas, complexity and volume of clinical trials increases, with study sites facing growing operational and logistical challenges. These may be administrative, financial, technological, or workforce-related and can prevent sites from meeting trial obligations, inhibiting long-term site sustainability. Here we outline a suggested framework (with metrics) designed to address three key pillars: site infrastructure, workforce, and the establishment of a 'trial funnel' to maintain sufficient trial volume. We review key site-level challenges and barriers to success in clinical trial conduct and argue that issues could be mitigated by sponsors investing programmatically in their site partnerships, including investing in research-naïve sites. Long-term programmatic planning and investment has the potential to deliver greater efficiency and sustainability in trial delivery; site investment upfront would increase working capital for the site, maximizing commitment and security on both sides. This, however, requires safeguarding through the implementation of targets and metrics of success. Many of the challenges faced in modern clinical research can be mitigated by new and longer-term thinking, concerning the working relationship and methods adopted between sponsors and research sites.