The MRC Laboratories (UK) Unit in The Gambia has been responsible for conducting many interventional clinical trials and carrying out clinical and epidemiological research in the field. In this regard, MRC in The Gambia probably has the largest experience and best infrastructure of any comparable tropical research unit.

Examples of on-going clinical trials include studies on new vaccines against tuberculosis and meningitis (Bacterial Diseases Programme), treatment options in malaria in children (Malaria Programme), and vaccination strategies against measles (Viral Diseases Programme).

Good Clinical Practice
All clinical research is conducted in accordance with the GCP principles as laid down in the Consolidated Guideline for Good Clinical Practice published by the International Conference on Harmonisation in 1996 (ICH GCP Guideline). MRC UK provides guidelines for good clinical practice (MRC GCP Guidelines) that not only apply to interventional clinical trials on medicinal products but include any prospective study involving human participants and the administration of a treatment or type of management.

For almost three years the MRC Unit in The Gambia runs its Clinical Trials Support Office (CTSO), established by Dr Jenny Mueller in January 2006. The aim of the CTSO is to ensure adherence to the ICH GCP Guideline in clinical trials carried out at the Unit and to implement GCP procedures for all clinical research projects where not yet in place.

The CTSO supports investigators in conducting their studies in accordance with those requirements in all details and to consolidate on existing projects through regular GCP training for all cadre of new staff and for those already involved in clinical research.

Quality Assurance in Clinical Research
The CTSO was joined by Ms Vivat Thomas, an experienced nurse who worked at the MRC ward for over 25 years, as the Unit’s Clinical Trials Monitor. Several clinical studies get monitored by Vivat and investigators at MRC appreciate this support. Studies that are externally monitored also get support from the office through the additional monitoring by Vivat who works in collaboration with the external monitors.

She makes sure that clinical trials are conducted in accordance with the current approved protocol for the project, GCP and applicable regulatory requirements to ensure that the rights and well-being of study participants are protected and the data collected are reliable.

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. Further new SOPs will be written and existing SOPs reviewed regularly.

Training
Implementation and adherence to GCP would not be possible without training. Jenny and Vivat train research staff regularly in principles and guidelines of good clinical practice (GCP) and Human Subject Protection.

The Clinical Trials Support Office will continue to ensure that MRC (UK) in The Gambia meets the internationally required GCP standards in all aspects of clinical research.