How to improve clinical trials in Nigeria, by experts

Experts have developed a blueprint on how to improve clinical trials for drugs in Nigeria.

The experts at the 3rd Nigerian Annual Clinical Trial Summit with the theme: ‘Advancing Global Clinical Trials In The West African Sub-Region’, held recently, in Lagos, said the country needs more participation of people in clinical trials and clinical research process and that capacity building should start early. “It is not just people writing papers but getting their hands into the nitty-gritty of research,” they said.

The event organised by the Association for Good Clinical Practice in Nigeria, (AGCPN) had participant from within and outside the country.

The dignitaries who participated in the conference include: the Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Dr. Paul Botwev Orhii; the President of Bioresources Department Group (BDG), Prof. Maurice Iwu; President Chief Executive Officer (CEO) of Clintriad Incorporated United States, Dr. Anthony Ikeme; and Deputy Chief Executive in Charge of Safety Monitoring and Clinical Trials Division of Food and Drugs Authority (FDA), Ghana, Mrs. Delese Darko among others.

Speaking during the occasion, the Technical Officer Regulatory System Strengthening Department of Essential Medicines and Health Products, World Health Organisation (WHO), Geneva, Switzerland, Dr. Ahmed Bellah, said the summit was an excellent opportunity for like minds to meet and to agree on consensus, as well as to show that NAFDAC as a regulatory authority has done an excellent job in clinical trial.

“WHO has been working with NAFDAC within the context of Ebola and to review clinical trial. The review has been excellent and we look forward to continue support as well as we have a lot of ongoing activities with NAFDAC that will make us to look forward to ongoing activities and upcoming projects,” Bellah said.

He added that the key point is to understand who should be doing what and to provide them the opportunity and the responsibility of doing it.

Chairperson of AGCPN, Prof. Ifeoma Okoye said that the message is that they have identified some of the shortfalls of clinical trials in Nigeria.

“We need to work on the timeline to reduce bureaucracy. However, the regulations NAFDAC has in place right now are one of the best across the globe.

“What we have identified is just that the bureaucracy and the timeline have to be looked into. In terms of manpower development, we have identified that we should start early to get people interested in research from the elementary, secondary schools and tertiary institutions.

“We need more participation of people in clinical trials and clinical research process. That capacity building should start early. It is not just people writing papers but getting their hands into the nitty-gritty of actual research,” Okoye said.

According to her, beyond the capacity building that will involve introduction of building research capacity in the curriculum of the schools, there is need for a training that will run throughout the year.

“This is the kind of vibrancy of the capacity building aspect of clinical trials that we want to see happening throughout the county.”

Okoye said that there is the need to build capacity for different institutions to be able to retrieve their data. “So data retrieval system needs to be put in place, as well as protocol for attending to patients. Even if a patient is attended to in a specialist hospital in Enugu or a federal medical centre or in a private care; if somebody is treated for malaria in any of the hospitals, there should be a uniform standard of care.”

On his part, the Director General/ Chief Executive, National Institute for Pharmaceutical Research and Development (NIPRD) Abuja, Prof. Karniyus Gamaniel said that one of the aftermaths of the conference is that people will now start doing things differently as far as clinical trial is concerned in laboratories.

“People are also sensitized towards appreciating challenges of clinical trial in Nigeria. As a matter of fact, it is one major factor that impedes our development in terms of making our own drugs. I think it is a very good and timely meeting.

“The major challenge is availability and integrity of drugs. Overcoming this will mean organising meetings like this where people share ideas and network. Capacities are built. We also know that the President has signed the Health act. It is now an act of the National Assembly that is a guidance document. People will now focus into the tenets of that document. This is one forum that will sensitize people towards that.

“We made reference to the document in the meetings, the National Health Act. It forms the basis which we draw the National Health Research Act. It is a good meeting to sensitize people that there is a law, there is a guidance document from the National Assembly to guide not just other activities in the health sector, but including clinical trials,” Gamaniel said.

The Managing Director, ClinaPharm, Republic of Benin, Dr. Raouf Osseni, said there are many challenges in the sector because the industry is not yet developed in the area.

“It is just starting. We think the potential is huge. If you look at the map of the clinical trials in the area, you will see that most of the trials are performed in South Africa and some others in East Africa. There are less trials in West Africa than other parts.

‘This is because in West Africa you have a lot of differences in the regulation of the trials. This is a limiting factor. There are other challenges like the infrastructure. The lack of political will. The lack of funding and many others,” Osseni said.

He said that during the summit, they did a comparison of the clinical trials regulations in the West African sub-region. “We have seen that there can be a limiting factor for the sponsors to come here and to start home trials. That is why we think that it will be very interesting to have a kind of harmonization of the deregulation in the sub-region.”

He said that with multiple conferences, networking, spreading information within the scientific community in the sub-region would go along way.

The Executive Director, Atlanta Premier SMO, Gbolahan Fatuga regretted that there is a negative perception about conducting research in Nigeria. “What I tell sponsors is to also look at the positive aspects of it. It is really a matter of educating some of the sponsors to let them know what the opportunities are. We have all the infrastructure in place to actually run the process. We just have to make those regulations a little more transparent for people.

“The other aspect is to look at things from other regions. We should look into Indian and Chinese markets to also sponsor and to look within our companies for sponsors as well.”

Founder of Eureka Consulting with offices in Atlanta, Georgia, USA and Lagos, Iruka Ndubuizu said that something that kept coming out throughout the entire conference is the lack of standard in Nigeria to handle clinical trails.

“We don’t have very clear regulations to handle clinical trials in Nigeria. We spent the three days inspiring confidence in both physicians and researchers and hopefully, we have also reached out to sponsors that we can do this. But we do need the federal government to step in and to help get a clear regulation of how to do clinical trials.