International Clinical Trials Day is celebrated on 20th May 2021, to raise clinical trial awareness and honour clinical research professionals across the globe. This day celebrates the anniversary of the first clinical trial by James Lind in 1747 into the causes of scurvy on board the HMS Salisbury. In honour of this day, we are recognizing research scientists contributing to public health, medical advancement, and improved health outcomes.
Clinical trials entail the use of human volunteers to conduct research that will inform science intended to add to medical knowledge, primarily by improving human health and quality of lives through identifying and filling unmet medical gaps. They are considered as an evidence-based practice for producing high-level scientific evidence to guide clinical practice.
Clinical trials conducted globally have proven to strengthen health systems, expand health programs and have provided evidence for future health crisis response.
All clinical trials are guided by protocols that are approved and regulated by an accredited Institutional Review Board (IRB) that ensures the clinical trial is ethical, and the rights and safety of study participants are protected. The protocols must also adhere to Good Clinical Practice (GCP) which is a standard for the design, conduct, and reporting of clinical trials. This assures that the data is accurate, reproducible, and credible and that the study participants’ rights and confidentiality are protected even after the clinical trial is complete. The study participants must give informed consent voluntarily and are free to exit or withdraw from the trial at any given time without facing any consequences.
In Kenya, clinical trials that involve drugs intervention or medical devices must be approved and regulated by the Pharmacy and Poisons Board (PPB). The National Commission for Science, Technology and Innovation (NACOSTI) regulates and assures quality in science, technology and innovation, the institution accredits research institutes and approves all scientific research in Kenya.
Who Can Participate in Clinical Trials?
All clinical trials have guidelines, known as eligibility criteria; typically, the inclusion criteria include demographic, clinical, and geographic characteristics. In contrast, exclusion criteria are defined as features of the potential study participants who meet the inclusion criteria but present with additional characteristics that could interfere with the success of the study or increase their risk for an unfavourable outcome such as specific health conditions or medications that could interfere with the treatment being tested. These criteria help to reduce bias and variation in the study to get accurate data.
In summary, clinical trials are carefully designed, reviewed, and evaluated to ensure the efficacy and safety of new treatment as to the standard treatment.
What Are the Four Phases of Clinical Trials?
At KUTRRH, the Research and Clinical Trials Department works towards building research capacity and encouraging a research culture in the Hospital. One of our own, Dr Daniel Kanyatta – MBcHB MMeD (Neurosurgery), has published a paper with the Open Journal of Obstetrics and Gynecology and a different one with Interdisciplinary Neurology: Advanced Techniques and Case Management. He is also a reviewer of the American Journal Interdisciplinary Neurosurgery-Advanced techniques and case management.
To access these two very informative publications, use the links provided below:
- Access to Isocitrate dehydrogenase (IDH) mutation characterization and prognostication in a Kenyan hospital – A first case. https://www.sciencedirect.com/science/article/pii/S2214751921000888
- Chronic Subdural Hematoma, a Cause of Persistent Post-Dural Puncture Headache in the
Postpartum Period- https://www.scirp.org/journal/paperinformation.aspx?paperid=107798
For enquiries about clinical research at KUTRRH, please get in touch with the Research and Clinical Trials Department via deputydirector-research@kutrrh.go.ke and research.manager@kutrrh.go.ke