OPPORTUNITIES AND CHALLENGES FOR REGULATORY AUTHORIZATION AND OVERSIGHT OF CLINICAL TRIALS IN RESOURCE-LIMITED SETTINGS

Transcription

1 Regulatory Capacity Building Workshop: Vaccine Clinical Trial Review from Ebola to HIV, March, 2015, Kigali, Rwanda OPPORTUNITIES AND CHALLENGES FOR REGULATORY AUTHORIZATION AND OVERSIGHT OF CLINICAL TRIALS IN RESOURCE-LIMITED SETTINGS THE AVAREF REGULATORS EXPERIENCE By BENO N. Yakubu NAFDAC, Nigeria

2 The Challenges Vaccine clinical trials have been on the rise in the African Region in the past 10 years Top 3 WHO disease priorities which require new vaccines malaria, HIV and tuberculosis Malaria hospitalizations >100x higher cf other vaccine preventable diseases 34 million living with HIV, 3.1 million <15 years and 14 million in need of immediate antiretroviral therapy Complex candidates and approaches, complex designs and lack of correlates of protection for candidate vaccines Information about planned trials and target countries often lacking ahead of submissions of clinical trial applications Lack of common/ harmonized guidelines and procedures to facilitate multi-country trials. Inadequately-resourced and weak NRA capacity for regulatory oversight of clinical trials in Africa Timelines for clearance of CTAs often very long 2

3 The Opportunities WHO-HQ-RSS & AFRO Joint capacity Building Efforts through networking - African Vaccine Regulatory Forum (AVAREF) Commitment and technical support of competent NRAs (USFDA, Health Canada, EMA, Swiss Medic) Willingness of African NRAs and ECs to collaborate Financial support of global partners BMGF, EDCTP, PATH/MVI, Canadian CIDA (CHIV Initiative). 3

4 History of AVAREF Network approach to regulation of clinical trials proposed at workshop organized by WHO (Jan/2005) AVAREF-2, Burkina Faso, Sept 07 AVAREF-3, Tanzania, Oct 08 AVAREF-4. Nigeria, Sept 09 AVAREF-5 Kenya, Sept 10 AVAREF-6 Mozambique, Sept 11 AVAREF-7 Gabon, 2012 AVAREF -8 Uganda, Sept 13 AVAREF-9, Pretoria, South Africa Nov 2014 Development of model regulatory procedures (2005/2006) Birth of AVAREF (AVAREF-1 Accra, Sept 06) Joint reviews of CTAs and joint GCP inspections of phase II trial of Meningitis A vaccine using model procedures (2006) Networking TFI recommendation RD s vision Plenary presentations by product developers/regulators/researchers Task team meetings Joint reviews Closed meetings 4 Sixth meeting of AVAREF, Maputo, September 2011

5 African Vaccine Regulatory Forum (AVAREF Plus) INNOVATIVE WAYS OF PROVIDING OVERSIGHT FOR CLINICAL TRIALS IN SUB-SAHARAN AFRICA National Regulatory Authority AND Ethics Committees Scope Regulation of Clinical Trials Support from USFDA, Health Canada, European Medicines Agency Vaccine Regulation of Medicines Common strategy PACTA Annual meetings Exchange of information on CTA approvals Guidelines and tools Information sharing and collaboration AVAREF Members: Botswana Niger Burkina Faso Nigeria Cameroon Rwanda Central African Rep Senegal DRC Sierra Leone Eq. Guinea South Africa Ghana Tanzaania Gabon Uganda Kenya Zambia Malawi Zimbabwe Mali The Gambia

6 Why the African Vaccine Regulatory Forum (AVAREF)? Platform for information sharing by Product Developers on candidates, target countries and timelines for clinical trials Better communication and collaboration between NRAs and ethics committees, in African countries and with regulators of countries where product development is initiated. Provide expertise to regulators in support of regulation and evaluation of vaccines in the Africa region. Assist NRAs to improve quality of reviews and shorten review and approval times for clinical trial applications 6 Sixth meeting of AVAREF, Maputo, September 2011

7 OPPORTUNITIES UNDER AVAREF: trends Governance Capacity Information sharing Environment INITIALLY INFORMAL NETWORK FEW COUNTRIES Model procedures developed Review approval of CTAs and licensure of MenafriVac Since joint CT reviews -2 Joint GCP inspections OPPORTUNITIES FOR INTERACTION WITH EACH OTHER AT ANNUAL MEETING/OTHER ACTIVITIES INFORMATION SHARING WITH FDA, HEALTH CANADA AND EMA MORE EARLY PHASE TRIALS (MALARIA, EBOLA, HIV NOW DONE IN AFRICA AVAREF NOW 23 COUNTRIES Model procedures widely used in AVAREF countries Growth in Scope Malaria vaccine phase 3 RTS,S/AS01 CTA review in 7 countries covering 11 sites Trial approved within 6 months in all countries Vaccines against Ebola JOINT ACTIVITIES -JOINT REVIEW of CTA FOR EBOLA VACCINE WITH EAC TECHNOLOGY PACTR- REGISTRATION OF TRIALS VIRUAL PLATFORM MORE PRODUCTS (MEDICINES AND VACCINES) IN CLINICAL TRIALS AND IN AVARAEF COUNTRIES T

8 SUMMARY OF OPPORTUNITIES FOR REGULATORS IN AVAREF Pan African Clinical Trial Registry ensuring more transparency Joint Reviews Joint Inspections Tools Common format for submission, Guidelines for joint reviews and GCP Guidelines Information sharing Other regulators FDA, EMA, HC, DCVRN Other Regional Initiatives EAC of AMRH, NEPAD Fast Learning: Biologicals are complicated to regulate but have paved way for medicines CT regulation. More biologicals on the African continent in the last 10 years, more to come 8

9 Lessons learned High level of expertise and commitment exists in countries Mutual recognition and acceptance of common challenges provides incentive to work together Sharing best practices and challenging each other brings the best out of countries Capacity building activities (development of regulatory procedures for CTs, joint reviews and inspections) provided a foundation for: a path towards harmonization the design of "authentic learning" opportunities Capacity building should reflect in institutional development. Increasing ownership by countries signalled by: - confidence to identify and propose future joint initiatives - between meeting implementation of activities 9 Sixth meeting of AVAREF, Maputo, September 2011

10 10 Sixth meeting of AVAREF, Maputo, September 2011 WAY FORWARD Working outside annual meetings. Transparency in work processes Information sharing platforms strengthening Use of technology Capacity building Pooling of expertise is important More partners needed? Regional centres of excellence MORE COLLABORATION AND COOPERATION!! Sustainability Designating and sending delegates to annual meetings with own resources