Benefits of Conducting Clinical Trials in Nigeria
With the unwavering menace of infectious diseases, researchers need to keep developing new methods of diagnosis, prognosis and treatment. However, as the researches move towards breakthrough, clinical trials are needed to evaluate the effect of these discoveries and how they can be safely, efficiently and effectively implemented.
According to World Health Organization, W.H.O, a clinical trial is any research study that prospectively assigns human participants to one or more health-related interventions to evaluate the effect on health outcomes. Clinical trials are used in evaluating the safety and efficacy of a medical, surgical or behavioural intervention including new treatments in form of a new diet, drug, surgical procedure, diagnostic test and medical device. It is often used to compare the safety and effectiveness between the new treatment methods and the already established standard treatment.
As stated, clinical trials require research study on human participants most of which are directed to patients with specific health conditions. It may however involve healthy human subjects with no pre-existing medical condition.
Nigeria is considered as an under-developed country and statistics from the Association of Good Clinical Practice in Nigeria (AGCPN) shows that the health status of Nigeria’s population is below standard. The few efficient health facilities available are costly and cannot be afforded by majority. In a situation like this, clinical trials are an excellent platform to increase good healthcare access in Nigeria.
An increase in clinical trials conducted in an area would lead to the improvement of good healthcare access in terms of number and quality for its citizens. The populace have a chance to get a better treatment for health problems and have access to promising new treatments often not available outside the clinical-trial setting. In this case, clinical trials provide close monitoring, advice, care and support in addition to the treatment given to the patients or volunteers by experienced research team of doctors and other health care professionals who understands the disease or condition.
Nigeria is known to be susceptible to a number of diseases particularly those classified as Neglected and Tropical Diseases (NTDs). The country also has a diverse patient population with wide variety of races and ethnicities numbering over 300. This diversity gives room for a more accurate and precise result based on the population genetics. Weather and climate conditions are also favourable and allow research studies all year round.
With clinical trials, researchers have access to more medical records and statistics. Local health care workers also benefit from participating as it polishes their skills and make them understand the diseases better.
Role of NAFDAC in Clinical Trials
Standard clinical trials can only be conducted after approval by a health authority or an ethnic committee in the country where approval of the medicine is sought. These authorities are responsible for carefully examining the risk to benefit ratio of the trial before approval. In Nigeria, the two authorities capable of approving clinical trials are National Agency for Food and Drug Administration and Control (NAFDAC) and National Health Research Ethics Committee.
NAFDAC is a federal agency under the Federal Ministry of Health, Nigeria responsible for regulating and controlling the manufacture, distribution, sales, importation and exportation of food, drugs, chemicals and medical devices in Nigeria.
NAFDAC as a regulatory authority is in charge of approving the conducting of clinical trials in Nigeria. Before approval, it ensures that some criteria are met before the clinical trial can proceed. These criteria are also in line with the ethical requirements as used by U.N. National Institutes of Health (NIH). Some of which include scientific validity of the medicine, favourable ratio of risk to benefit of the medicine, informed consent and approval of the subjects and respect for human rights.
Here is a conclusion that the need to test newly developed methods of diagnosis, prognosis and treatment for diseases cannot be overemphasized. Conducting clinical trials is of utmost importance in making these interventions meaningful. Nigeria is lagging behind in this feat therefore, it is required that conducting clinical trials is encouraged and improved upon in order to better the treatment of diseases and the health status of its citizens.