Clinical Trials
The MRC Unit, The Gambia has been responsible for conducting many interventional clinical trials and carrying out clinical and epidemiological research in the field. Examples of on-going clinical trials include studies on new vaccines against tuberculosis, pneumonia and malaria as well as treatment options in relevant diseases.
Good Clinical Practice
All clinical research is conducted in accordance with the principles of good clinical practice (GCP) as laid down in the Consolidated Guideline for Good Clinical Practice published by the International Conference on Harmonisation in 1996 (ICH GCP Guideline). Interventional clinical trials on medicinal products are carried out in line with the requirements of the ICH-GCP Guideline and take European and US regulations into account. MRC UK provides guidelines for GCP (MRC GCP Guidelines) that are based on the ICH-GCP principles and include any prospective study involving human participants and the administration of a treatment or type of management.
For more than five years the MRC Unit, The Gambia has run a Clinical Trials Support Office (CTSO), established by Dr Jenny Mueller. The aim of the CTSO is to ensure adherence to the ICH GCP Guideline in clinical trials carried out at the Unit. The CTSO supports investigators in conducting their studies in accordance with these requirements including the ethical principles that have their origin in the Declaration of Helsinki. The CTSO also ensures that all the regulatory requirements are met for the conduct of clinical trials and communicates with the Medicines Board on behalf of the sponsors.
The office has established and coordinates a Clinical Trials Group that meets once a month to discuss practical issues and procedures arising with the conduct of clinical trials.
Quality in Clinical Research
The CTSO was enforced by Ms Vivat Thomas to monitor the conduct of clinical trials. She is an experienced nurse and certified as a Clinical Research Associate (CRA) by the Association of Clinical Research Professionals (ACRP). She makes sure that clinical trials are conducted in accordance with the current approved protocol for the study, GCP and applicable regulatory requirements with the aim that the rights and well-being of study participants are protected and the collected data are reliable. Vivat also works in collaboration with the external monitors to provide oversight in addition to the sponsor’s monitoring; a support that is highly appreciated by the Unit’s investigators.
In addition, the office developed several written standard operating procedures (SOPs) to ensure the uniformity of conduct of clinical research and adherence to international requirements. The range of SOPs is continuously being improved and existing SOPs are reviewed regularly.
Recently, the three clinical diagnostic laboratories were assessed as meeting the requirements of Good Clinical Laboratory Practice (GCLP). This achievement provides assurance that the laboratories will satisfy the current expectation of GCP for the analysis of samples from clinical trials.
Training
Implementation and adherence to GCP would not be possible without training. Jenny and Vivat train Unit research staff regularly in principles and guidelines of GCP and research ethics to protect human research participants. In addition, the CTSO encourages and supports any external GCP training provider using the MRC facilities for its courses and provide GCP training to collaborators in the Sub-region.
The CTSO will continue to ensure that MRC Unit, The Gambia meets the internationally required GCP standards in all aspects of clinical research and to share their knowledge and experience with networking institutions and collaborating clinical trial teams.
