Keynote Speech By Prof. Adeyeye C. M
Director General NAFDAC
Global Congress On Oncology Clinical Trials
Sheraton Hotel Ikeja, Lagos
14th November, 2018.
Protocol
I feel very honoured for the invitation to deliver the keynote speech on, “Partnering with Regulatory Agencies” at this Global Congress on Oncology Clinical Trials. The Congress, organized to address the challenges of clinical trials for oncology among the black population is quite germane given the significance of the challenge posed by under-representation of blacks in clinical research.
Knowing that blacks are inexplicably affected by cancer, the population should be getting high-level representation with the ever-increasing treatment innovations. Unfortunately, this is far from reality as, in many instances, diagnostic and therapeutic decisions that affect the well-being and health outcomes of blacks are usually based on data gathered in populations of patients not representative of the blacks.
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.
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. 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. 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. This 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.
Trovan, (Trovafloxacin) tragedy in Nigeria, that claimed the lives of many children, was a case of improper conduct of clinical research. The disaster could have been avoided if all parties involved in the trial had duly followed the principles of Good Clinical Practice. Nonetheless, it is good to note that both the clinical trial regulatory system and the clinical research environment in Nigeria has 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.
The National Agency for Food and Drug Administration and Control (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, 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. (Please visit website – www.nafdac.gov.ng).
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
- 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
- Academic clinical trials
Aside from the other regulatory controls, 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.
NAFDAC’s Clinical Trial Regulatory Activities include:
- Clinical Trial Authorization
- Good Clinical Practice (GCP) Inspection
- Clinical Study Report/Data Evaluation
- Surveillance & enforcement
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.
National Agency for Food & Drug Administration and Control in collaboration with National Health Research Ethics Committee (NHREC) and the Federal Ministry of Health developed the Nigeria Clinical Trials Registry (NCTR). NCTR is set up to support clinical trial registration. It also provides to central Pan African Clinical Trials Registry (PACTR) in order to ensure representation of such trials on the platform data. The two organizations will refine the collaboration for better utility of the Registry. Information on NCTR can be found on http://nctr.nhrec.net/FAQ.php
NAFDAC always advocates for collaboration to build new partnership, strengthen existing ones and create synergy in regulation at different levels (National, Regional and International). This is with the realization that positive partnership enhances the impact and effectiveness of an action, through combined and more efficient use of resources as well as strong commitment from each partner. The Agency has leveraged on some successful partnerships with international governments, regulatory networks, development organisations, donor Agencies, academic institutions, among others, in order to fulfil its responsibility of ensuring the quality, efficacy and safety of regulated products in Nigeria.
The Agency’s collaboration with different organisations, with key interest in clinical trials, include African Vaccine Regulatory Forum (AVAREF), Association for Good Clinical Practice in Nigeria (AGCPN), National Health Research Ethics Committee (NHREC), World Health Organisation (WHO), and many others.
One of the dividends of NAFDAC’s partnership with AGCPN is the annual Clinical Trial Summit which draws experts both in Diasporas and within in order to encourage the development of clinical trial enterprise in Nigeria, build capacity in clinical trial innovations and to create public awareness.
Our collaboration with AVAREF has come a long way especially in the development of various guidelines for different processes in the regulation of clinical trials as well as in human capacity building.
Nigeria is working with other Regulatory Authorities in the West African Health Organisation, (WAHO) to improve the regulatory landscape of the region through harmonisation of our guidelines.
Furthermore, through her clinical trial regulatory activities, the Agency, has been a key partner in the development of several products within and outside the country through joint activities. For example, EchiTab -G (anti-snake venom), MenAfrivac (Meningitis A vaccine), RTS,S (Malaria vaccine) and Ebola Vaccines (ZEBOV and MVA). The active participation of the Agency in the joint review of Ebola vaccines clinical trial protocols with other Stringent Regulatory Authorities, during the Ebola outbreak, facilitated the development of the product. This swift pace of product development challenged regulatory environment globally, especially those of resource-constrained Sub-Saharan African countries, with the reality of pooling scarce resources together and attracting medical research to the continent. The Agency is currently participating in the global effort to develop therapies and vaccines for Lassa fever infections.
As a key stakeholder in regulation of clinical trials in Nigeria, the Agency is ready and also calling on all stakeholders to partner with NAFDAC in ensuring that clinical research is conducted in the most efficient manner and that an enabling environment is created to attract more trials into the country.
The Challenges
There are several challenges faced by the Agency in regulating clinical trials but the most critical is the discovery in the course of our activities that there are quite a number of unauthorised clinical trials going on in various institutions in the country. This is unacceptable and is one of several reasons clinical data emanating from this part of the world are rarely considered as credible by counterparts in other climes. The conduct of clinical trials without authorisation from NAFDAC is a serious violation of the law that attracts severe penalty. It is unfortunate that this is happening despite all efforts being made by the Agency to create awareness in clinical trial regulations.
On this note, and as a way of encouraging transparency in our activities, NAFDAC requires clinical researchers to always register their studies, on WHO primary registry PACTR and NCTR. This is not only for regulatory monitoring but to also give visibility to research engagements on a global arena in order to attract more trials to Nigeria.
We are not unaware of other challenges like inadequate capacity among researchers, infrastructure including poor power supply, lack of accredited bio-analytical laboratories etc. Candidly, there are no challenges insurmountable if we are committed to strong partnership, harnessing our resources and building strength in order to make our country a pleasant destination for global clinical trial.
CONCLUSIONS
The challenges of cancer morbidity and mortality in Nigeria cannot be tackled by the government alone and so should be viewed as the problem of everyone. Hence, there is need for everyone to unite in the fight against cancer! I have no doubt that the country is blessed with all it takes to achieve this feat if only we are ready to do it the right way.
I wish to reiterate that NAFDAC is always ready and open to collaborations with both national and international organisations, with strong focus on continuous improvement in clinical trial regulations.
Once again, I wish you a good deliberation during this meeting and also implore you to partner with NAFDAC in bringing our clinical trial environment to global standards.
Thank you all.
