Jornal de Ensaios Clínicos
Acesso livre

Abstrato

A Cross-Sectional Descriptive Study to Assess the Preparedness of Private Medical Practices to Conduct Clinical Trials across Different Therapeutic Areas in Cross River State, Nigeria

Sylvester Ekom Nsed Ebaye*, Manoj P. Jadhav

Background: Development of new drugs to cope with emerging and existing diseases resistant to current treatment regiments needs rapid, structured clinical evaluations of such therapies in suitable clinical trial subjects. Nigeria, resource poor country, is trying to foster the field of clinical research to strengthen its medical and healthcare capabilities.
Material and Methods: A cross-sectional descriptive study focusing on human resource capacity for clinical trials, fitness of private medical practices as trial sites and therapeutic areas of interest of private medical practices in Cross River State, Nigeria was performed. We randomly selected 66 private medical practices. We administered close ended questionnaire. Twelve of these 66 were further selected based on their geographical location in Cross River, Nigeria, for three focus group discussions of 4 medical directors each. Two members of the regulatory authorities and institutional review board in Cross River State had in-depth interviews conducted by the authors.
Results: Six (9%) of medical directors of the private medical practices had ever participated in clinical trial study and only 17 (26%) of the practices had ever published in an academic journal. Fortunately, this result showed that over 64 (97%) of these private medical practices were highly desirous of participating in clinical trials and 65 (98%) desired to publish or co-author original articles in reputable academic journals. High percentages of the practices had interest in therapeutic areas across predominant diseases such as cardiovascular, malaria, respiratory, diabetes, HIV and testing of new medical devices.
Conclusion: Majority of private medical practices were well equipped to conduct and highly desirous to participate in clinical trials in Cross River State, Nigeria. Further studies with larger cohort and more emphasis on the ICH-GCP guidelines, specific training of the investigators and the staff are warranted.