Ifeoma Okoye

Ifeoma Okoye is improving the prospects for infrastructure and human resource development in the health care sector in Nigeria and Africa by creating a framework for sponsored clinical drug trials that will make the continent an offshore outsourcing destination for ethical clinical trials.

Ifeoma was exasperated by the deteriorating conditions in most hospitals and health centers in Nigeria, including the major teaching hospital at which she worked, and realized that receiving shipments of donated and often obsolete equipment from Europe was inefficient. So Ifeoma started the Association for Good Clinical Practices in an effort to make Nigeria a world class destination for offshore clinical trials. Becoming a destination for outsourced or sponsored clinical trials offers significant potential for infrastructural development of the health care sector. Properly conducted clinical trials are often the most expensive component of drug research and development. Sponsors pay for certain infrastructural and human development needs depending on negotiations with clinical investigators. Therefore, sponsored clinical trials provide an opportunity for health care facilities to meet their infrastructural and human development needs without having to wait for government allocations or charity. Ifeoma believes that well-developed and ethically conducted clinical trials can benefit a developing nation like Nigeria in a number of other ways through the provision of collateral social health services and data that will aid the sector in health planning, determining disease prevalence and drug resistance patterns, as well as developing enhanced economic activity for the general populace not participating in the trial. She also believes that clinical trials in Nigeria can have a positive impact on ongoing clinical research activities that would ultimately enhance health programs focused on malaria research, AIDS vaccine trials, microbicide trials, onchocerciasis trials, schistosomiasis trials, and diabetes and breast cancer research.

In Nigeria health care infrastructure has collapsed in most government run facilities; labs have no equipment, pharmacies have no drugs, and patients have to buy their own cotton swabs. Private sector healthcare is expensive and resource poor, with few facilities offering technology assisted diagnosis and health care. The recently introduced National Health Insurance Scheme is still immature, and coverage still excludes large sections of the population. It may take decades for it to reach its full potential. Meanwhile the vast majority of Nigerian citizens, including the more than 50 percent that live on less than US$1 a day, face the prospect of a heavy disease burden and high mortality and morbidity rates. Age expectancy in Nigeria is 43 years for men and 48 years for women. Only 3 percent of the population is above the age of 63.

Increased interest in Africa as a destination for clinical trials is currently fueled by growing research evidence that drug responses are often genetically determined and drugs need to be tested among different ethnic groups for efficacy. There is increased pressure from the United Nations and World health Organization for the pharmaceutical industry to establish more trial sites among African populations. However, there is no existing institutional, policy or legislative framework for clinical trials in Nigeria; only 0.2 percent of all clinical trials conducted worldwide are done in Africa and South Africa is currently the only African country with the institutional capacity to conduct accredited clinical trials. In addition, many developed nations are reaching clinical trial saturation; the quality of their health care systems is a disincentive for their citizens to participate in potentially risky clinical trials.

The few clinical trials that do presently take place in Nigeria are often conducted without any regulation or monitoring and frequently result in unethical and often illegal trials, unusable test results, and injury to human research subjects. In 2007 the Nigerian government sued Pfizer Pharmaceuticals for trials it sponsored in the 1980s. The researchers lacked the capacity to conduct acceptable and ethical trials and the institutional review infrastructure was not well developed. As a result, there was a high rate of mortality and morbidity among the human research subjects and the sponsors could not use the trial results. Lesser-developed bioethical standards often attract genome, stem cell, and other contentious research that might not meet bioethical criteria in developed nations. All in all, the lack of oversight and review capacity exposes the human research subjects to exploitative and unethical treatment.

The research and development of traditional African medicine—which is popular especially among low income groups—is also hampered by the lack of a clinical trial framework. Their clinical trials are not scientific or systematic and the anecdotal nature of the evidence of traditional medicine’s efficacy is insufficient to inspire capital investment that could support mass production and distribution. As a result, traditional medicine and its practitioners who could potentially be a significant component of health care delivery in Nigeria remain unregulated and contribute to the continent’s poor health indices.

After conducting exhaustive research to identify international standards and requirements for hosting clinical trials, Ifeoma brought her colleagues together in October 2005 for a conference. The objective of the conference was to present all the opportunities for health sector infrastructure and human capacity development offered by sponsored clinical trails and discuss the need to improve the clinical research capacity in Nigeria and Africa based on regulatory and ethical frameworks. Sixty-five medical, pharmaceutical, and research practitioners attended the conference she titled ‘Drug Development, Clinical Trials and Pharmacovigilance in Nigeria.’ The conference resulted in the formation of the Association for Good Clinical Practices in Nigeria (AGCPN), a national membership association whose objectives are to train Nigerian clinical research personnel and advocate for policy and legislative support for Good Clinical Practices (GCP) in Nigeria. Not surprisingly, Ifeoma was unanimously elected its President.

In May 2006 AGCPN held its first international conference: ‘Promoting Health Research Capacity in Nigeria within an African Context: Toward the Development of National Good Clinical Practice.’ The conference brought together Nigerian and international stakeholders to review best practices, examine the current state of human research subject protection, identify gaps in the national framework on GCP, and develop African GCP standards. A total of 187 national and international delegates attended including the National Agency for Food and Drug Administration and Control (NAFDAC) and the Federal Ministry of Health. At the conclusion of the conference AGCPN was invited by NAFDAC to contribute to the drafting of National GCP guidelines and strengthen the ethical review and regulatory oversight capacity in Nigeria.

Ifeoma and the conference participants also set qualification criteria for clinical research investigators, established a working group to develop a Nigerian curriculum for training investigators in GCP, and developed working procedures for institutional review boards and ethics committees. The National Guidelines for Good Clinical Practices were adopted through legislation in 2007. AGCPN facilitated the Ministry of Health to strengthen the review capacity of institutional review boards and ethics committees in 22 medical centers across the country that have been identified as suitable sites to host clinical trials in Nigeria. A procedure for accrediting them is currently being developed while AGCPN continues to monitor their development.

In October 2006, Ifeoma organized the first training workshop—‘Research Ethics And Human Subject Protection’—to develop the capacity of clinical research investigators in Nigeria to conduct internationally acceptable clinical trials. More than 100 research investigators participated in the training. The trainers were drawn from various international organizations and the Association of Nigerian Clinicians in the US, a 9,000 member organization that was eager to partner with Ifeoma. Pfizer Pharmaceuticals sponsored a training module on clinical trail conduct. The workshop also included a one day special training session for medical correspondents of media houses to sensitize the media and forestall the sort of sectionalized headlines that have led to recent public outcries against clinical trials in Africa and create public awareness.

AGCPN continues to grow and has become the vehicle through which Ifeoma develops Nigeria’s health infrastructure. In 2007 AGCPN hosted a second training workshop to facilitate clinical trial monitors to conduct oversight and prepare them for international accreditation with a total of 198 monitors trained. AGCPN will provide continuous training and education to the investigators and monitors and is in partnership with a number of international clinical practice certification organizations.

The workshop also led to the registration of the first Nigerian Clinical Research Organization, an important part of the GCP framework whose role is to negotiate fair terms and conditions between sponsors and clinical trial facilities.

Ifeoma has started spreading the word about GCP on continental scale. In June 2006 she attended the Pan-African Bioethics Initiative Conference in Yaoundé, Cameroon and presented a paper on ‘Good Clinical Practice on AVR Programs in African Countries.’

Her presentation sparked regional interest in developing a harmonized framework for GCP for Africa. Ifeoma will continue to spread her work across the continent. In March 2008, she was in Ethiopia again advocating for a harmonized African framework and guidelines. In May 2008 she spoke about conducting clinical trials in emerging economies to an audience of pharmaceutical and biomedical industry executives in London. AGCPN will provide continuing education and training to investigators, monitors, and review bodies until they receive final accreditation from recognized international regulatory organizations. Ifeoma’s plan is that in five years time indigenous drugs will also be made subject to clinical trials and, with the stronger reputation of the clinical trial sector in Nigeria, find wider acceptance and attract greater capital investment.

Ifeoma is head of the department for radiology at University of Nigeria Teaching Hospital (UNTH). Not satisfied with health care delivery and the state of infrastructure, and realizing that medical professionals were not saving the all lives they could be saving, Ifeoma decided to look for ways that she as a doctor could improve her working environment. She formed the UNTH Resource Foundation to raise funds and equipment for the hospital, and partnered with the West African Medical Relief Group.

After a tedious and failed effort to import medical equipment and supplies that had been donated by various hospitals and individuals in England, Ifeoma overheard a colleague speak about the benefits of sponsored clinical trials. Intrigued, she investigated further and realized clinical trials offered a more efficient way to meet the infrastructural and human development needs of the health care sector in Nigeria. Undaunted by the fact that there was no existing framework within Nigeria to conduct internationally acceptable clinical trials she launched the first GCP initiative in Africa.

As a student Ifeoma used drama to raise money for charitable causes, started public speaking as secretary of a medical group in university, and was a member of Medical Women Association of Nigeria. As its President she established a Well Woman Clinic after refurbishing an abandoned building where she initiated breast self-examinations and free screening for cervical cancer programs. She also ran a summer camp for the children of working parents.

Ifeoma has always wanted to be a doctor, but in order to do so she had to overcome widespread stereotypes about female suitability. Ifeoma describes her motivation as ‘Not quite happy with little parts.’