A Cross-Sectional Descriptive Study to Assess the Preparedness of Private Medical Practices to Conduct Clinical Trials across Different Therapeutic
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.
This study was a prospective cross-sectional descriptive with analytical component in design. This research was made to comply with any law(s) and regulation(s) addressing the conduct of clinical research in Cross River State specifically and Nigeria in general. The research sort the affirmative approval decision of Cross River State Health Research Ethical Committee (CRSHREC), that the research proposal had been reviewed and could be conducted at the participant facility sites within the constrains set forth by the HREC, the health facility, Good Clinical Practice (GCP) and the applicable regulatory requirements. Cross River State is home to an academic hospital, the University of Calabar Teaching Hospital, Calabar. There were 22 other in-patient public health facilities, comprising 2 hospitals run on Public Private Partnership (P3) contract, 5 faith base facilities made up of 3 general hospitals and 2 specialist care centres for tuberculosis and leprosy. There were 15 other general hospitals wholly owned and run by the state government as general/public hospitals, unevenly distributed across the 3 political senatorial districts of the state. There were 85 private medical practices headed and managed by their proprietors. These proprietors were qualified medical practitioners, licensed to operate as private–for–profit general or specialist practices. These medical entrepreneurs were referred to as Medical Directors (MD) of their practices. They are held responsible for any lapses or failure in the quality of medical services by regulators of healthcare services in the country. Theses MDs were the principle investigators (PI) of clinical trials in their facilities. They are responsible for the day-to-day provision of clinical services and any clinical trial that could take place in their practices.
- Thanks and Regards,
- Alpine
- Associate Editor J
- journal of Clinical Trials
- clinicaltrials@eclinicalsci.com