Expert Interviews
Rethinking Global Clinical Trials Through a Social and Operational Lens
Salvatore Nocerino is a Lead CRA II with solid experience in global clinical trials and site management. His profile stands out for combining strong operational expertise with an academic background in Medical Anthropology and Global Health, supported by a Master’s degree in Medical Management.
In this interview, Salvatore shares a unique perspective on how social, cultural, and structural factors influence clinical trial execution. Drawing from his experience across diverse settings, including low-resource environments, he discusses practical approaches to improving site management, adapting informed consent processes, managing operational risks, enhancing patient retention, and strengthening collaboration across global teams.
ABRS:You have worked as a CRA and also as a researcher in an ethnographic context. How would you apply your understanding of social and cultural factors to improve site management and communication with investigators in global clinical studies?
Salvatore: Clinical communication in global studies should go beyond protocol and regulatory requirements. Effective site management requires understanding how clinical research interacts with local healthcare systems, cultural expectations, and patient realities.
From my background in ethnographic research, I approach site communication in a more context-sensitive way, ensuring that investigators understand not only what the study requires, but how those requirements fit within their local environment.
This includes considering factors such as access to care, trust in institutions, and health literacy. By integrating this perspective, communication becomes more effective, site engagement improves, and study implementation is better adapted to local conditions.
ABRS: Based on your experience in both clinical trials and in Uganda, how would you adapt the informed consent process in settings where decision-making is collective, while still ensuring compliance with GCP?
Salvatore: Informed consent remains an individual and regulatory requirement, but in many settings, decision-making involves family members or caregivers.
Based on my experience, particularly in Uganda, I would maintain full compliance with GCP while adapting the process to be more culturally aware. This means acknowledging the role of caregivers, providing additional explanations when needed, and ensuring that the participant’s autonomy is preserved.
Informed consent should not be seen as a single document, but as an ongoing process of communication, understanding, and ethical engagement.
ABRS: Having managed clinical sites and worked in contexts with structural limitations, what critical risks do you anticipate in the execution of studies in low-resource countries, and how would you manage them from a monitoring or leadership role?
Salvatore: One of the main risks is the gap between protocol requirements and the actual capacity of the local healthcare system to support follow-up, safety management, and continuity of care.
To address this, I would focus on early risk identification, realistic feasibility assessments, and close collaboration with sites. Mitigation strategies may include reinforced follow-up procedures, contingency plans, additional training, and logistical support for patient retention.
Successful execution in these settings requires combining scientific rigor with operational flexibility.
ABRS: Considering your monitoring experience and your research on barriers such as cost, transportation, and family networks, what strategies would you implement to improve patient retention in multicenter clinical studies?
Salvatore: Patient retention strategies must be adapted to local realities rather than standardized.
From my experience, retention is influenced not only by patient motivation, but also by practical factors such as transportation, financial constraints, and family responsibilities.
To improve retention, I would implement strategies such as decentralized follow-up when possible, transport support, use of local referral networks, and collaboration with community resources.
Retention improves when study participation is aligned with the patient’s daily reality.
ABRS: You have interacted with investigators, clinical teams, and community stakeholders. How would you leverage this experience to strengthen collaboration between sponsors, sites, and global teams?
Salvatore: Strong collaboration requires moving beyond top-down communication and incorporating local perspectives.
I would promote open and bidirectional communication between global teams and sites, encouraging early engagement with local stakeholders and recognizing patient and community insights as valuable inputs.
This approach improves alignment, reduces misunderstandings, and supports more effective study execution across different regions.
Thank you, Salvatore, for sharing your insights and experience. Your perspective highlights the importance of integrating clinical rigor with a deep understanding of social and cultural contexts in global research.
We truly appreciate your time and thoughtful contributions, which bring valuable clarity to the challenges and opportunities in clinical trial execution across diverse settings.
