NAFDAC canvasses blacks’ inclusion in clinical research
With the increasing burden of cancer, it becomes vital that assiduous efforts be made to include blacks during clinical research on the emerging cancer diagnostics and therapies, Director-General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof Christiana Mojisola Adeyeye, has said.
She said this in her key note speech at the Global Congress On Oncology Clinical Trials held today in Lagos with the theme “Partnering with Regulatory Agencies.”
“A growing body of literature indicates that the effectiveness of a drug, the likelihood of it causing side effects and the nature of those effects can all vary between people of different descent. When clinical trial data are generated on diseases that particularly affect black population, the data are not necessarily applicable to the blacks that suffer a higher burden of these diseases if these blacks have been under-represented or not included in the studies.
“National Institute of Health (NIH’s) definition of blacks is “a person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American. Even among blacks there could be disparities defined by environment, diet or genetic disposition,” NAFDAC boss said.
According to a WHO report, cancer is the second leading cause of death globally and seventy percent (70%) of these deaths were from low and middle-income countries.
NAFDAC boss said the inclusion of blacks during clinical research on the emerging cancer diagnostics and therapies cannot be overemphasized knowing the outcomes of recent studies that reported race-based disparities with specific toxicity and survival outcomes on a Phase I clinical trial of some anticancer agents.
She noted that Trovan, (Trovafloxacin) tragedy in Nigeria, that claimed the lives of many children, was a case of improper conduct of clinical research, saying the disaster could have been avoided if all parties involved in the trial had duly followed the principles of Good Clinical Practice.
“Nonetheless,” she added, “it is good to note that both the clinical trial regulatory system and the clinical research environment in Nigeria have greatly evolved over the years. Though NAFDAC is standing today as one of the prominent regulatory systems in Africa, the Agency is still yearning for more improvements.”
According to her, “The threat of cancer in our society today cannot be over emphasized as it has become a chronic disease claiming millions of lives every year. In Nigeria, the incidence, prevalence and mortality of cancer has been on a substantial increase in recent times and has posed a tremendous burden on patients, families and the society.”
She said NAFDAC has a responsibility to safeguard public health through the execution of her mandate as provided in the NAFDAC ACT CAP N1, LFN 2004, to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, medical devices, bottled and packaged water, chemicals – generally referred to as regulated products.
By this mandate, she posited, the Agency is to ensure access to safe, quality and efficacious medical products to the Nigerian populace.
“Furtherance to the NAFDAC mandate to ensure safety and efficacy of the medical products, the Food, Drugs and Related Products (Registration, etc) ACT CAP F33, Sections 5(1) empowers NAFDAC to regulate and control clinical trials in Nigeria. The Act states in part that, no person shall, in the course of his business carry out the following for the purpose of a clinical test, unless he is a holder of a valid clinical trial certificate issued by NAFDAC and that the trial is to be carried out in accordance with the terms of the certificate and the provisions of any regulation in force.
“Import or supply a drug, drug product, cosmetic or medical device; or Procure the importation or supply of a drug, drug product, cosmetic or medical device; or Procure the manufacture or assembly of a drug, drug product, cosmetic or medical device.
“In line with the Section (30) of the NAFDAC Act, which empowers the Agency to make Regulations, the Clinical Trial Regulations-draft (still under process) and the Good Clinical Practice (GCP) guidelines that have been put in place to give full effect to the provisions of these Acts.
“The conduct of clinical trial is mandatory for the following category of products: New or relatively new molecule for which safety and efficacy has not been determined such as: Drugs for new indication; Drugs for new patient group (for example paediatric or geriatric); New combination of drug products; New dosage schedule or regime; New drug delivery system; Generic products and Academic clinical trials,” she added.
Aside from the other regulatory controls, Prof. Adeyeye said the Agency has put in place various strategies to accomplish this mandate that include product registrations/listing, inspection of production facilities, laboratory analysis of regulated products, investigation and enforcement activities, Good Manufacturing Practice (GMP), and Hazard Analysis and Critical Control Points (HACCP) as well as effective post marketing surveillance and regulation of clinical trial.
On NAFDAC’s Clinical Trial Regulatory Activities, Prof Adeleye said “Over the years, we have been able to set up a robust system, especially in the area of clinical trial regulations, and is still expanding its capacity in terms of infrastructure and human resources, to cope with the continued scientific innovations in health research.
“The huge investment undertaken by the Agency in building the capacity of the staff has seriously improved the service delivery. We have been able to adequately review and approve very impressive number of study protocols including WHO – sponsored ones. Likewise, monitoring of the approved studies through Good Clinical Practice inspection of the trial sites is on-ongoing, to ensure compliance with the approved protocols, protection of the well-being of the participants and credibility of the data emerging from the trials,” she posited.
