Involving study sites in trial design and minimizing the number of contractors is the key to more efficient drug trials according to new research.
The study – published in the Journal Tropical Medicine and Infectious Disease – looked at similarities and differences between pharmaceutical industry sponsored trials, product development partnership trials and investigator-initiated trials.
The key finding is that “Early involvement of sites in trial planning and adoption of tailored and adapted quality approaches are critical for clinical operations improvement for all sponsors.”
This need is particularly important for studies conducted in developing countries and rural areas according to the authors.
“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.”
They also suggested that – based on 40 interviews conducted with site staff – drug companies are starting to do more to involve sites.
“In the PDP and IIT models with consortia, most of the investigators mentioned that they were more involved in the protocol development than in the industrial trials.
“However, some principal investigators highlighted that they are currently witnessing a changing trend with most pharmaceutical companies, where upfront mechanisms are being established for the site’s contribution.”
Effective contract research organization (CRO) and contractor management - irrespective of the type of study – is also important for efficient drug research according to the authors.
“The efficacy of a clinical trial is hampered by a complex management structure and the involvement of multiple contact layers on the sponsor side.”
Regulations
The study authors also acknowledged the impact regulations have on drug research efficiency and urged regulators to take their findings into account in the development of future guidelines.
“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.
“It is hoped that the revision of the clinical trials guidelines with a focus on quality-by-design, including critical-to-quality factors and quality tolerance limits, will further alleviate the unnecessary process burden in clinical research, contributing to fostering innovation in the design, conduct, and outcomes of clinical trials.”
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