Early site engagement key to success, trial sponsors say

Biopharmaceutical sponsors benefit from involving sites in clinical trial development, according to new research, which suggests project management is vital for successful studies.

Recent research compared the operational differences between industry-sponsored trials, product development partnership trials, and investigator-initiated trials to identify key drivers of inefficiency in clinical research.

The key finding is that understanding a research site’s capabilities is critical to the success of the project.

“Early involvement of sites in the planning and tailored quality approaches were considered critical for clinical operations performance,” the authors wrote, adding that getting to the site capabilities is particularly important for smaller developers.

“For studies conducted in resource-constrained settings, operational adaptation to research ecosystems implies deep knowledge of the site and partnership that is built on trust.”

Investigator guidance

The authors also noted the findings are aligned with the International Conference of Harmonization Good Clinical Practice guidelines, which emphasizes investigator empowerment.

Drug trial sponsors that work closely with sites also have access to a deep understanding of local regulations, which is a potential advantage, according to the authors.

“On another note, the guidance of investigators is critical to meet countries’ regulatory and ethics committees’ requirements. Perhaps it could be more efficient that, when study sites are selected through calls for grant applications, the sites are offered the opportunity to design and adapt the study to their settings. This will improve the adoption and rollout of the product after its authorization for marketing in these settings.”

The study also showed that research sites benefit from early interaction with sponsors and contract research organizations, citing experience as an example.

“The involvement of researchers is also an opportunity for [the] site’s capacity strengthening as junior or mid-career researchers will benefit from a positive exposure to upstream research processes. This could furthermore contribute to their professional career development.”

Unsplash/Johannes Plenio