Expert Interviews
Behind Every Successful Trial Is a Committed Professional: A Conversation with a Kenyan Research Expert
In today’s rapidly evolving landscape of global clinical research, Kenya is emerging as a key contributor to scientific advancement and innovation across Africa.
In this interview, James Kipkoech, a Clinical Research Associate (CRA) based in Nairobi, Kenya, shares his perspective on the country’s growing involvement in clinical trials — from the implementation of early-phase studies to maintaining data integrity and ensuring participant safety.
With a deep understanding of local challenges and international standards, James highlights the opportunities Kenya offers for collaboration, capacity building, and regulatory progress. His insights reflect the dedication of African clinical research professionals who are shaping the future of ethical, high-quality, and globally connected clinical research.
ABRS:What are the main challenges in implementing Phase I trials in Kenya?
James: Phase I trials represent the first introduction of an investigational drug into humans, usually involving healthy adult volunteers. The main goal is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, with early detection of adverse events being the top priority.
In Kenya, implementing Phase I studies presents several challenges:
Participant Recruitment
Recruiting healthy volunteers remains one of the biggest challenges. Many people in Kenya still perceive clinical trials as activities meant for the sick, which makes it difficult to engage healthy participants.
Mitigation strategies:Conducting community education and awareness campaigns to demystify clinical research.
Using trained local educators to build trust and improve understanding.
Providing clear and transparent information about the goals and safety of Phase I trials.
Regulatory Challenges
The regulatory framework in Kenya is thorough and patient-safety–oriented, but the approval process can be complex and time-consuming.
Mitigation strategies:Engaging local regulatory experts to guide submissions and ensure compliance.
Preparing protocols and informed consent forms (ICFs) that clearly address ethical and safety standards.
Maintaining close communication with regulatory authorities to align with both local and international requirements.
Infrastructure and Resources
There is limited access to advanced pharmacological laboratories and specialized research facilities needed for early-phase trials.
Mitigation strategies:Partnering with international research organizations to share expertise and resources.
Upgrading existing laboratory capacity to support pharmacokinetic and safety testing.
Limited Skilled Personnel
There is a shortage of trained investigators and staff experienced in early-phase studies.
Mitigation strategies:Providing specialized training programs to build local capacity in Phase I operations and safety monitoring.
ABRS: How can data quality be improved in HIV and vaccine studies?
James: A clinical trial aims to answer specific research questions by generating data to prove or disprove a hypothesis. The quality and reliability of that data are fundamental to the outcome of any study — a clinical trial is only as strong as the data it produces.
To improve data quality and reliability in HIV and vaccine studies, the following measures are essential:
Establishing a strong Clinical Data Management (CDM) system to ensure high-quality, reliable, and statistically sound data.
Ensuring compliance with regulatory standards such as ICH-GCP and 21 CFR Part 11.
Applying Good Clinical Data Management Practices (GCDMP) to maintain consistency and accuracy.
Reviewing the study protocol from a database design perspective to ensure clarity and alignment.
Developing a comprehensive Data Management Plan (DMP) that defines:
Database design and testing procedures
Data entry and tracking guidelines
Quality control measures
SAE reconciliation and discrepancy management processes
Data transfer, extraction, and database locking procedures
Additional critical activities include:
Database management: Building, testing, and maintaining the clinical trial database.
Data collection: Designing CRFs and eCRFs to capture accurate and complete data.
CRF tracking: Monitoring entries for accuracy and completeness.
Double data entry: Having two independent operators enter data separately for validation.
Data validation and cleaning: Conducting ongoing quality checks and resolving discrepancies.
Medical coding: Using standardized dictionaries such as MedDRA and WHO-DD.
Database locking: Ensuring data are fully verified and ready for statistical analysis.
ABRS: What are the key recommendations to ensure participant safety and ICH-GCP compliance in Africa?
James: The most important aspect of any clinical trial is participant safety. Drug safety is a continuous and evolving process that requires constant vigilance and adherence to international standards. Every study must be designed to protect the rights, safety, and well-being of participants, while ensuring the credibility of the data collected.
In Africa, clinical research is expanding rapidly, which makes it essential for investigators and research sites to remain compliant with ICH-GCP guidelines. However, this comes with unique challenges such as limited infrastructure, variable regulatory capacity, and inconsistent access to training.
To strengthen participant protection and compliance, I recommend:
Conducting all trials in accordance with the Declaration of Helsinki, ICH-GCP, and applicable local regulations.
Developing informed consent forms in local languages, ensuring they are clear, culturally appropriate, and easy to understand.
Providing GCP training to all site personnel, tailored to each individual’s role.
Involving community representatives in Safety Monitoring Committees (SMCs) and Data Safety Monitoring Boards (DSMBs).
Educating participants about the investigational product and their rights throughout the study.
Strengthening regulatory authorities to improve oversight and ethical review processes.
Training local clinical trial monitors to focus on safety and GCP adherence.
Implementing risk-based monitoring and using digital systems for real-time safety reporting.
By reinforcing training, transparency, and regulatory collaboration, Africa can continue building a research environment that prioritizes both participant safety and scientific integrity.
ABRS: Why is continuous training essential for ensuring the quality of clinical trials?
James: Clinical research professionals play a vital role in the design, conduct, and oversight of clinical trials. To ensure that every study is conducted ethically, safely, and in full regulatory compliance, continuous training is indispensable.
Maintaining Quality and Compliance:
Regulations and best practices are constantly evolving. Continuous training keeps research teams aligned with the latest GCP principles, local regulations, and sponsor requirements, helping prevent errors and non-compliance.
Enhancing Participant Safety:
Well-trained personnel are better equipped to identify and manage potential risks and adverse events, ensuring that participant safety remains the top priority throughout the study.
Improving Efficiency and Data Quality:
Training strengthens competence and consistency, reducing protocol deviations and improving the accuracy and integrity of study data.
Adapting to New Technologies:
As the research environment evolves with emerging digital tools and data science methods, ongoing education helps professionals apply these innovations effectively, enhancing both efficiency and quality in trial execution.
In summary, continuous training is not just a regulatory requirement — it’s a cornerstone of clinical excellence, patient protection, and data reliability.
ABRS: How can Kenya strengthen its role in global infectious disease clinical research?
James: Kenya continues to face a significant burden of infectious diseases such as HIV/AIDS, tuberculosis (TB), and malaria, but this also positions the country as a valuable contributor to global health research.
To strengthen its role as a regional and global hub for infectious disease clinical research, Kenya should focus on several key areas:
International Collaborations:
Partnering with global research organizations helps share expertise, technology, and funding, ensuring that local studies meet international standards.Public–Private Partnerships:
Collaboration between public institutions like KEMRI and private companies can foster innovation, accelerate research timelines, and expand access to new technologies.Human Resource Capacity-Building:
Establishing structured training and mentorship programs for early-career scientists will build a stronger and more sustainable local research workforce.Laboratory and Digital Infrastructure:
Strengthening laboratory capacity and investing in digital health technologies will enhance Kenya’s ability to conduct large-scale and complex trials efficiently.
By advancing these areas, Kenya can continue to evolve into a strategic hub for global infectious disease research, driving innovation, scientific collaboration, and improved public health outcomes across the region.
We want to express our sincere gratitude to James Kipkoech for sharing his valuable insights and perspectives on clinical research in Kenya.
His reflections highlight the country’s growing capacity, commitment to quality, and potential as a strategic hub for global clinical trials.
We hope this interview inspires our readers and fosters a deeper appreciation of Kenya’s vital role in advancing global health and scientific innovation.
Thank you, James, for your time, expertise, and dedication to excellence in clinical research!