Quality Clinical Trial Monitoring in Nigeria: The Impact of Regulatory Oversight and Resource Capacity


Mon, Jun 24 10:00AM
M 03


Quality Clinical Trial Monitoring in Nigeria: The Impact of Regulatory Oversight and Resource Capacity

Abstract Summary

A quantitative, cross-sectional explanatory study design and descriptive statistical analysis was conducted. The study sample was taken from twelve (12) clinical research outfits representing the Teaching Hospitals, Federal Medical Centers, and all of the private Clinical Research Organizations in which any form of clinical trial activity is currently being conducted – covering the four regions of the country. One hundred and fifty-six (156) respondents, involving 13 participants from each of the 12 institutions were selected from the various clinical trial sites in the country. The sampling frame for the study include thirteen (13) participants (four (4) PIs, four (4) RNs, one (1) PM, one (1) CRC/CRM, one (1) study statistician, one (1) laboratory technician and one (1) pharmacist) from each of the institutions which are composed of three (3) institutions from the Northern region, three (3) institutions from the Southern region, three (3) institutions from the Western region and three (3) institutions from the Eastern region of Nigeria. . Following are the names of said institutions: Northern Region of Nigeria (1) Aminu Kano Teaching Hospital, Kano. Kano State. (2) University of Maiduguri Teaching Hospital, Maiduguri. Borno State. (3) National Hospital, Abuja. Southern Region of Nigeria (1) University of Portharcour Teaching Hospital, Portharcourt. River State. (2) University of Lagos Teaching Hospital. Lagos. Lagos State. (3) Federal Medical Centre, Uyo. Western Region of Nigeria (1) University College Hospital, Ibadan. Oyo Sate. (2) Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife. Osun State. (3) Federal Medical Centre, Abeokuta. Ogun State. Eastern Region of Nigeria (1) University of Benin Teaching Hospital, Benin City, Edo State. (2) University of Nigeria Teaching Hospital, Enugu. Enugu State. (3) Federal Medical Centre, Owerri. As there was no readily available data to ascertain the clinical researcher population in Nigeria, the sample was based on Confidence Level (CL) of 95% and Confidence Interval (CI) of 8. Error margin was accepted to be 5% and the response distribution is expected to be 50%. Therefore, if only 50% of the sample picks an answer at CI of 8, we are 95% assured that if the entire population of clinical researchers in Nigeria was surveyed, we would come up with a value of between 42% (50-8) and 58% (50+8) of the wider population of the clinical researchers responding exactly the same way. Survey questionnaires were used to record data on the resources available for the conduct of clinical investigations, regulatory oversight; and their impact on the ethical, legal and regulatory conduct of clinical investigations involving human subjects in Nigeria. This focus was on the regulatory oversight, trial management and monitoring in these set-ups. Statistics program (SPSS) was used for the data analysis; making use of descriptive statistics. Approvals for this study were obtained from both the University of Liverpool/Laureate Committee on Research Ethics (CRE); and the National Research Ethics Committees (NRECs) Nigeria, , as represented by the University of Ibadan/University College Hospital IEC. The survey questionnaire was reviewed by the Dissertation Advisor and Informed Consents were obtained from the respondents before any engagement with them.

Poster Presenter

Elizabeth Olubukola Adeniran
University of Liverpool/ Laureate
United Kingdom

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