Prof. Ifeoma Okoye, President, Association for Good Clinical Practice in Nigeria (AGCPN) Professor of Radiology, College of Medicine, University of Nigeria, Nsukka & University of Nigeria Teaching Hospital (UNTH) Enugu, NigeriaAFRICAN COORDINATOR OF CITI (Collaborative Institutional Training Initiative)

Presented by

ASSOCIATION FOR GOOD CLINICAL PRACTICE IN NIGERIA (AGCPN)

• an initiative that has been promoting responsible conduct of Human Research and developing the infrastructure for clinical trials in Nigeria through government-regulatory body advocacy /media sensitisation, conferences and training workshops.

• an umbrella organisation networking investigators/clinical trialists in Nigeria

DEARTH OF INFLOW OF RCTS

• 100,000 clinical trials are carried out worldwide each year, of the total; only about 10% of them is performed in the developing countries, 1% in Africa and very minimal fraction performed in Nigeria

• Available data show that out of the 1600 clinical trials conducted in Africa only about 1% is placed in Nigeria as compared to about 50% placed in South Africa, 6% in Egypt, 55% in Uganda and 3.9% in Kenya.

• Nigeria has not had significant HIV/AIDS trials like other countries in Eastern/Southern Africa

Clinical Trial Capacity: Large Headroom in Africa

Relatively low level of drug development activities in Africa

Clinical Trial Capacity: Large Headroom in Nigeria

Ample headroom for expansion

Diseases Represented In Ongoing Diseases Represented In Ongoing Clinical Trials In Nigeria Is A Clinical Trials In Nigeria Is A

Reflection Of:Reflection Of:

Problems of reproductive health

Acute infectious diseases

Nutritional diseases

CNS

Cardiovascular

Cancer

Diabetes

Others

Epidemiologic Transition

Changing Disease Patterns

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Dis

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3 ACTIVITIES SINCE LAST CITI MTG

Distribution of AGCPN members that are enrolled into the CITI Program.

4 INSTITUTIONS

HAVE REGISTERED

WITH CITI

THE 4 REGISTERED INSTITUTIONS & the buy 4 get 1 free

Reasons advanced for this poor compliance

IDEALY AGCPN WOULD LIKE TO

Participants at the opening ceremony of the Enugu Zonal ToT

As AGCPN continues its advocacy to influence political will and commitment of policy makers to

• Legislate and make mandatory RCR/GCP /Ethics/Bioethics Education for its research scientific community.

• Invest in strengthening agencies like regulatory bodies, National/Institutional Ethics committees, and GCP initiatives through properly voted BUDGETRY ALLOCATION

HOW CAN YOU HELP?

Title Conditions Status1 Trial of SAVVY Vaginal

Gel and HIV in Nigeria HIV Infections Recruiting

2 Cellulose Sulfate (CS) Gel and HIV in Nigeria

Chlamydia Infections;   Gonorrhoea;   HIV Infections

Terminatedb/c of safety concerns

3 Abuja Heart Study: Prospective Epidemiologic Investigation of Cardiovascular Diseases

Cardiovascular Diseases;   High Blood Pressure

Not yet recruiting

4 Epidemiologic and Molecular Features of Cervical Cancer in Nigeria - Project Itoju (Care)

Cervical Cancer;   Cervical Intraepithelial Neoplasia; Human Papillomavirus Infection

Recruiting

5 Pulmonary Hypertension in Patients With Sickle Cell Disease in Nigeria

Pulmonary Hypertension; Secondary Pulmonary Arterial Hypertension;   Sickle Cell Disease

Recruiting

Table 1: Registered Clinical Trials in Nigeria. Data culled from http://clinicaltrials.gov.

Genetics of Type 2 Diabetes in West Africans

Diabetes;   Hypertension;   Nephropathy;   Obesity;   Retinopathy

Recruiting

Use of Oral Probiotics as an Adjunctive Therapy to Fluconazole in the Treatment of Yeast Vaginitis

Vaginal Candidiasis Recruiting

Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria

Malaria Completed

Walking Study for Stroke Rehabilitation

Stroke Recruiting

Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria

Malaria Completed

Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

Breast Cancer Recruiting

Table 1: Registered Clinical Trials in Nigeria. (Continued)

Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

HIV Infection Completed

Evaluation of 4 Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children

Fever;   Malaria Active, Not-recruiting

Genetics of Type 2 Diabetes Among Han Chinese

Diabetes;   Hypertension;   Nephropathy;   Obesity;   Retinopathy

Recruiting

Luteal v. Follicular Phase Surgical Oophorectomy & Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor + Br. CA

Breast Cancer Recruiting

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

Cervical Cancer Completed

Table 1: Registered Clinical Trials in Nigeria. (Continued)

Evaluation of Safety and

Efficacy of Artemether-

Lumefantrine Tablets in

African Infants and

Children With

Uncomplicated P.

Falciparum Malaria

Plasmodium Falciparum Malaria

Completed

Comparing Methotrexate

Followed by Misoprostol to

Misoprostol Alone for Early

Abortion

Unwanted Pregnancy Completed

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

Pneumococcal Disease Active, not-recruiting.

Combination

Chemotherapy After

Surgery in Treating

Patients With Stage I,

Stage II, or Stage III Breast

Cancer

Breast Cancer Recruiting

Misoprostol for Preventing

Postpartum Hemorrhage

Postpartum Haemorrhage Completed

Table 1: Registered Clinical Trials in Nigeria. (Continued)

THE TASK MAY APPEAR HERCULIAN BUT IT IS DOABLE WITH ALL HANDS

ON DECK!