A clinical trial is a study investigation on new treatment or medical device to determine their safety and efficacy in treating a disease.
At CREA-N, we recognise that the foundation of clinical trials is the willingness of participants to invest their time and effort for a study. We endevour to include patients and the public in the development, implementation of clinical trials and dissemination of associated outcomes.
A clinical trial is a research study investigating new treatment or medical devices to determine their safety and effectiveness in treating a disease. Clinical trials are designed to answer important questions such as:
There are 4 key phases in developing new treatments for human use. The safety of the research participants is emphasized in each phase.
Pre-clinical studies are done in human cells and animals to show that a potential new medicine is safe and can treat a specific disease. If this stage is successful, national regulatory authorities and ethics committees must give permission for the potential new medicine to be investigated in human research participants.
The potential new medicine is tested for the first time in a small group of participants (20-80). This is done to assess the safety of the potential medicine, to determine the appropriate dosage, to determine what the body does to the medicine (pharmacokinetics) and what the medicine does to the body (pharmacodynamics).
The new medicine is tested is a few hundred people to see if works against the disease of interest while continuing to evaluate its safety.
This phase involves an even larger participant population (ranging from hundreds to thousands), to evaluate the effectiveness of the new medicine against the current medicine for the disease of interest. Phase 3 also continues to gather safety information. Marketing approval for the new medicine is requested from regulatory authorities such as the Kenya Pharmacy and Poisons Board (KPPB) or the Food and Drug Administration (FDA) in the United States for use by the general population. Doctors can now prescribe the new medication to their patients.
This phase starts after the regulatory authorities approve the new medicine for marketing.
Phase 4 studies will continue assessing the safety of the new medicine over time. Potential side effects caused by the new medicine are assessed over a longer period of time.
Comprehensive review and approval of a clinical trial protocol by qualified medical and scientific experts.
An Institutional Review Board (IRB) is a team of experts who ensure that a clinical trial is designed safely and fairly. It protects the rights and well-being of clinical trial participants.
In Kenya, the KPPB serves as an IRB.
Continuous monitoring the safety of the participants by data and safety monitoring boards.
Before the study can begin, the participants must be provided with all of the information they need to make the informed decision to participate in a research study. Once they understand this information, they willingly sign an informed consent form.
Sponsors who ensure that the medical team involved in the conduct of the trial studies are qualified by education, training, and experience.
An independent ethical board plays a key role in the safety and well-being of participants. They evaluate the ethical aspects of a study and ensure that the study will follow the Good Clinical Practice guidelines, before participants are enrolled in a study.
Why should you consider participating in a clinical trial?
Access to novel treatments and/or medical devices otherwise not available outside the clinical trials.
Provides patients with an opportunity to be an active participant in the management of the disease or condition.
Evidence of better health outcomes as patients receive close monitoring, medical care, and support by qualified research physicians and other health care professionals who understand your disease or condition.
By participating in clinical trials, you might not immediately benefit from the treatments but your contribution to medical research will ultimately in improving medical care.
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