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Presented by. 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, Nigeria - PowerPoint PPT Presentation
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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
Dis
ease
s o
f d
evel
op
ing
co
un
trie
s
Dis
ease
s o
f d
evel
op
ed w
orl
d
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!