What led to your decision to form a society?
Africa has significant unmet health needs. The burden of infectious diseases and non-communicable disease presents a major challenge to the public health agenda for many countries due to limited resources and competing health priorities.
Clinical research plays a key role to deliver solutions to reduce the burden of diseases through new treatments and interventions.
There was this shared vision of forming a society that would bring together Clinical Research professionals in the country, to pool our ideas, expertise, experience, and the collective desire to promote clinical trials in Kenya and the East Africa region. The society was long overdue.
The actualisation of this idea started in 2021 when a working group was formed, which then led to the recruitment of a larger team of about 20 professionals.
Most Kenyans are unfamiliar with clinical trials and more so those running in the country...
Many people will quickly associate research with a laboratory and a microscope. But there is indeed limited understanding of the research involving drugs, vaccines, or devices on human beings, which is what is referred to as clinical trials. Within the clinical research industry, to run a trial, different stakeholders are involved.
In addition, Kenya has a robust regulatory framework in ensuring the safety of clinical trial participants is protected. Regulatory agencies (Kenya Pharmacy and Poisons Board - PPB), National Commission for Science Technology and Innovation (NACOSTI) and ethics committees such as Scientific Ethics and Review Unit (SERU) at KEMRI provide approvals and oversight in ensuring the trials are conducted according to the laws of Kenya, international guidelines, and industry norms.
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What does it take to run a clinical trial in Kenya?
One needs to submit the protocol and other supporting materials to an ethics review committee, PPB and NACOSTI before embarking on any trial-related activity. The regulatory and ethics committees, therefore, review the scientific rigour of a trial, the qualifications and experience of researchers and that the well-being of trial participants is protected.
Is there a database of clinical trials?
Several publicly accessible databases exist. The PPB portal lists all trials being conducted in Kenya. The Pan African Clinical Trial Registry (PACTR) for clinical trials in African countries and is recognised by WHO and other international clinical trial registries such as clinicaltrials.gov. These registries are accessible to the public free of charge.
Some Kenyans believe clinical trials are a path for quick cash or rather reimbursement. What policies exist or measures are needed to ensure that the public is educated and protected?
Ethics and regulatory bodies safeguard those participating in research from any potential harm and the public from research that will not benefit them.
These bodies have very strict guidelines to ensure clinical trials adhere to the three main pillars of the International Conference of Harmonisation – Good Clinical Practice (ICH- GCP) which provides a global standard for carrying out trials: patient safety, ethical compliance, and data integrity.
ICH-GCP is further complemented by national regulations, in Kenya this is defined in the Pharmacy and Poisons Act CAP 244. The trials are monitored, and regular audits and inspections are also carried out to ensure compliance with the protocol, and regulations and that participant safety is maintained. The process of obtaining informed consent is given close attention to and it involves checks for the literacy of participants and understanding of what they are signing up for. Participants also have the right to withdraw from a clinical trial at any time, and their decision must be respected.
The ethics bodies ensure the reimbursed amount is fair compensation for the participant’s burden of participating in a trial considering time from their routine activities, and costs of travel by ensuring reimbursement i.e., is not too little or too excessive to unduly influence trial participation.
Are there channels to direct funding or support young budding researchers?
We have sponsors/funders that are providing direct support to build clinical trials infrastructure and/or purchase equipment like fridges and laboratory equipment. The sponsors/funders also do support training activities for persons involved in research through face-to-face meetings or through virtual platforms.
Some of the research partners offer training grants and scholarships and from these efforts, we have seen exponential growth in the number of clinical research facilities and clinical research manpower in the last 10 years or so. CRSK will augment these efforts by providing a platform for continued professional development and mentorship for young researchers.
Who can be a member of the society?
All individuals within the clinical research industry in different capacities/cadres including students.