Kenyan researchers are facing a significant setback as slow approval processes and role duplications across organizations hamper progress in over eight clinical trials, leading to losses exceeding Sh180 million this year. Additionally, two clinical trials valued at Sh28 million have been withdrawn.

Despite the Pharmacy and Poisons Board (PPB) reporting 36 ongoing trials, scientists argue that the actual number could be higher, with numerous applications stuck in the approval stage, curtailing Kenya's potential to develop crucial drugs for its citizens.

Clinical trials, as defined by the World Health Organization, are research studies that investigate new tests and treatments, evaluating their effects on human health outcomes. Such trials are vital for testing medical interventions, including drugs, vaccines, surgical procedures, devices, and preventive care.

In a meeting involving representatives from Research Ethics Committees, PPB, the National Commission for Science, Technology and Innovation (Nacosti), the Kenya Revenue Authority, the Clinical Research Society of Kenya, and Clinical Research Organisations, six researchers expressed frustration over the delays in their trials, attributing them to a slow approval process.

Among the lost trials were studies on an antibiotic drug and a COVID-19 vaccine for children, which were to be conducted by Professor Walter Jaoko, Director of KAVI Institute of Clinical Research at the University of Nairobi. Prof Jaoko highlighted that the approval process, which takes an average of 180 days or about six months, is a significant factor contributing to the loss of clinical trials.

The delay primarily occurs during the approval stages, where a protocol goes through multiple committees, including research ethics committees, PPB, the National Commission for Science and Technology, and local county reviews. Prof Jaoko emphasized that the delays impact the recruitment of participants, causing sponsors to opt for faster approval processes in other countries, such as Rwanda.

Rwanda's success in shortening approval periods to 60 days, compared to Kenya's 180 days, has made it a preferred destination for clinical trials. Prof Jaoko suggested that the solution lies in making the approval process more efficient, potentially adopting parallel submissions, as seen in Rwanda.

He noted that external funding is crucial for research in Kenya since the government's limited resources hinder comprehensive support. The National Research Fund, responsible for advancing science, technology, and innovation, allocates only Sh1.5 billion for all research sectors, including health, which requires about Sh30 billion.

The impact of lost trials extends beyond monetary losses, affecting capacity building, employment opportunities, and the local economy. Prof Jaoko emphasized the need for a streamlined process, stating that when Kenya becomes part of the global research community, it stands to benefit from various studies that may not directly impact the country but contribute to global scientific knowledge.

Dr Bernard Langat, acting head of the Directorate of Digital Health Policy and Research at the Ministry of Health, acknowledged the need for stakeholders to work on parallel submissions and emphasized the importance of presenting a business case for clinical trials to demonstrate their economic impact.

Efforts are underway to streamline the approval process, including parallel submissions and the establishment of a single platform for simultaneous reviews, aiming to reduce approval times and enhance transparency. Despite these challenges, stakeholders remain committed to addressing the obstacles hindering the timely progression of vital clinical trials in Kenya.

 

Article by RB Reporter

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https://nation.africa/kenya/health/clinical-trial-approvals-headache-for-kenyan-researchers-4467838