Building Research Team for Disaster and Funding in Resource Poor Settings Dr. Augustine Onyeaghala Global Health Trial Workshop, Abuja January, 2017. Email: aaonyeaghala@gmail.com

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Highlights Background Statement of problem and Justification Disaster Management concept and Clinical Research Competencies for Clinical Research Team Responsibility of the research team. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Presentation Objectives Understand the meaning of disaster research Justification for building the right team Basic concepts of disaster management Application of disaster management to disaster research Basic competences required for clinical research team Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Background : Basic Definitions Disaster: A disaster is a sudden, serious disruption of the functioning of a community or a society involving widespread human, material, economic or environmental loss and impacts, which exceeds the ability of the affected community or society to cope using its own resources (Wikipaedia) Economic effects of disaster Mortality /morbidity Loss of capital Mobilization and diversification of resources to curtail primary disaster Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Research: An investigative process employed to address gaps, provide solution, facts and generate new information. Team Building : A process of getting diverse people to work together and effectively in order to achieve the desired result. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 In summary We need a team of professional, who will work effectively and efficiently using evidence based approach (research) to mitigate, prevent, manage and monitor health disasters. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Background Cont’d In the words of the President of the World bank Jim Young Kim: “The world was woefully unprepared for the outbreak of Ebola. There is need for emphasis on building robust health systems, as it is a multiple-win approach. Nations cannot simply focus on disease surveillance., but effective health care has to follow. Fight against epidemics such as Ebola can improve health systems, economic prospects, and multilateral cooperation in mobilizing public and private funds.” [1] 1. Jim Yong Kim [2016]. Conference on Ebola with World Bank Group and Parliamentarians Jointly organized by the Parliamentary Network and the World Bank. Available at: http://www.worldbank.org/en/news/feature/2015/03/12/conference-on-ebola-with-world-bank-group-president-jim-yong-kim-and-parliamentarians-jointly-organized-by-the-parliamentary-network-and-the-world-bank . Accessed on 11th January, 2017. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Implication Adequate preparation is required for effective management of disasters Building robust health systems of which clinical research is a component becomes inevitable Focus on epidemiological data is not sufficient Using research methods and technologies to provide solutions is crucial Good health systems provide a win-win situation. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Some Health Disasters in Nigeria Ebola Outbreak of 2014 –Patrick Sawyer Syndrome. Meningitis outbreak in Nigeria and other African countries 2009-10 Nigeria recorded 9086 cases and 562 deaths. The highest in Africa. Lassa Fever-Almost becoming endemic. Zika Virus – expecting to outburst. Antimicrobial Resistance – a big challenge to global health Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Brain Storming /Critical Thinking Question Do you think that currently, Nigeria has an effective clinical research team who will help manage, mitigate and reduce economic and social burdens of sudden outbreak of medical disaster (s)? How do we move forward ?? Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Statement of Problem Most disasters emerge unannounced Currently no core clinical research disaster response team is available [ Compare Field Epidemiologist] Most solutions are sought for after the disaster has emerged Lack of best available evidence worsens treatment, management and prognosis. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Justification for Building Clinical Research Team for Disaster Predictive and Preventive approaches are better than curative Great generals are assembled earlier before any major national wars. Economic gains and man power development. Enhances local building of capacity Prevent loss of resources through capital flight. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Who constitutes the Team ? Research Team PIs CoPIs Nurses CRAs CRCs Data Managers Safety Monitoring Committee Pharmacists Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Disaster Management : Basic Concepts Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Mitigating Disaster Mitigate Determine Risk Vs Exposure Systematic Review of available evidence Evaluate Interventions Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Team Preparation Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Research Team Response Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Competencies for Clinical Research Team GHTN competency concept designed for CRPs,[2] advocated the following skills for clinical research team : Good knowledge of scientific thinking Adequate knowledge of Design & Planning of Research Knowledge of protocol development Ability to analyze and interpret research data 2. GHTN [2016]. Global Competency Framework for Clinical Research available at https://globalhealthtrials.tghn.org/global-competency-framework-clinical-research. Accessed on 10th January, 2016. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Research Ethics, Quality and Risk Management Adequate knowledge of ethics and conduct of ethical research GCP / QMS ICP/ICD Risk and safety management Regulatory issues Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Competences cont’d. Research Operations Good knowledge of data collection (Precise, and accurate) Safe guarding of data through maintenance of database GCLP for Clinical laboratories Site Management Initiation, selection, monitoring and close outs Scientific report writing/communication Management of resources. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Responsibility Assemble the right clinical research team for disaster management Impact the required skills and certification Liaise with academic institutions to develop and implement novel programs in disaster research Conduct Research Play advocacy roles. Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Funding Research What is our national budget for Research ? Basic truths about funding of research Research is business Most sponsors fund studies which address their interest. Competence and track record are essential for attracting funds Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Organizations that fund research : CDC. Bill and Melinda Gates Royal Society for Tropical Medicine [RSTM] GSK Pfizer Local Sponsors US National Institute of Health [NIH] Global Health Governments of : Germany, Japan, China Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017

Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017 Questions ??? Dr Onyeaghala, GHTN Workshop Abuja 28 January, 2017