Nigeria As Potential Hub For Global Clinical Trials | Independent Newspapers Limited
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Nigeria As Potential Hub For Global Clinical Trials

Posted: May 7, 2015 at 1:05 am   /   by   /   comments (0)

By Hassan Zaggi, Abuja


Recently, the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Paul Orhii, inaugurated the Nigerian Clinical Trial Technical Working Group (CT-TWG).

The Working Group, which consists of professionals with international experience and extensive knowledge of clinical trials, aims to make Nigeria a clinical trial destination hub in the world.

Drug testing lab

Drug testing lab

No doubt, the need to develop more effective and safer drugs to tackle existing disease and also tackle new and emerging diseases, especially in a fast developing country like Nigeria, cannot be said to be over-stressed.

According to medical experts, the conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare.

Drug research, development and promotion, experts further said, have grown to a multi-billion dollar global business.

Findings showed that the global pharmaceutical market is expected to reach 1.3 trillion USD in 2020. The most worrisome aspect here is that, most of this revenue is generated and controlled by pharmaceutical companies with headquarters in Europe and North America.

This, therefore, underscores the importance of technical working inaugurated by the NAFDAC Director General considering that Nigeria has  large potentials for the conduct of clinical trials.

Health economists estimate that Clinical trials have the potential to generate more resources than crude oil for Nigeria and that clinical research remains one of the top five national sources of income for Nigeria. Unfortunately, it has not been fully tapped.

“The huge population of Nigeria is a great asset. Clinical researchers would rather conduct clinical trials in a single country than run trials in multiple countries.

“Nigeria’s large and diverse populations, large number of people who do not abuse drugs, large number of hospitals which can serve as points for recruitment of clinical trial participants, large number of highly skilled health care practitioners, an organised clinical regulatory system, efficient courier services, transport systems and communication networks, and registered clinical trial support services. These are all incredible assets the country should celebrate,” one of the experts revealed.

While inaugurating the technical working group, the NAFDAC boss, Paul Orhii said that Clinical trial is one of the core mandates of NAFDAC as enshrined by law.

It covers investigations such as new or relatively new chemical entities or herbal formulations for which safety/efficacy profile has not been determined; drug for new indications; drugs for new patient population group; new combination drug products; new dosage schedule/regimen; new drug delivery system and academic clinical trials.

To accomplish the above coverage, the agency, he explained, had to key into international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects. Hence, the formulation of clinical trials guidelines and regulations by his agency with the assistance of World Health Organisation (WHO).

The implementation of the guidelines and regulations will ensure the generation of credible scientific data that can be accepted internationally. This will further lead to transparent and predictable processes that will attract a lot of international investments.

“The membership of the committee was intentionally draw from different experts groups to achieve holistic multifaceted, diverse and well coordinated approach to bring Nigeria Clinical Research sector at par with global practices. They are highly accomplished experts in their various fields and recognized nationally and internationally,” Orhii stressed.

The terms of reference of the Technical Working Group among others include reviewing of all current and past efforts at transforming the Nigerian clinical Research sector and synchronize these efforts into one; reviewing all issues impeding the growth of clinical research sector in Nigeria and make recommendations to the Director General of NAFDAC.

Other terms of reference include making clear actionable recommendations to the Director General of NAFDAC on the way forward in transforming and promoting clinical research in the country and create clinical trial awareness to both the lay and medical communities in Nigeria on issues dwelling on the research of medicines, old or new.

He charged the Group to make clinical trial to be seen as a social good that it is. First is to get the public to think about participating in clinical research. That way, participants would not be looked at as scapegoats, but rather seen as contributing to the prevention, diagnosis and treatment of diseases.

Findings shows that clinical trials has benefits to both the patients and the economy.

Clinical trials that are well –designed and ethically executed are the best approach, according to experts,  for eligible participants to play an active role in their own health care; gain access to and benefit from new research treatments before they are widely available (this could be huge for life threatening conditions such as HIV and cancer); obtain expert medical care and additional diagnostic testing (that would otherwise be unaffordable) at leading health care facilities during the trial; provide opportunity for patients to make a contribution to their health and other people (including the health of future generations) by contributing to medical research and clinical trials on acute debilitating illnesses may provide access to emergency evacuation services.

Similarly, the experts noted that well developed and ethically conducted Clinical Trials can also benefit a host of developing nations like Nigeria in many ways.

Among potential benefits are provision of collateral social health services and data that will benefit entire society in health planning such as determining diseases prevalence and drug resistance patterns; benefits of employment and enhanced economic activity for the general populace not participating in the trial; post-research benefits might include enhancing health-care or research facilities, providing critical equipment, training of health-care and research staff, and training individuals in research ethics.

Other development benefits, the experts further explained, can also include provision of social amenities for the local region from which subjects are sources such as the digging of boreholes for clean water, other physical infrastructure such as roads or vehicles for the participating health facilities; furthermore any single research trial could be an isolated endeavour or form part of a long-term collaboration between the population and the sponsor/researchers.

Long term collaboration embodies engagement with and a commitment to the population. It can also provide the population with long-term training, employment, investment, and additional research on other health issues.

Profits from direct sales of proven interventions or from intellectual property where this is shared with local players in the clinical trials can also be a benefit.