Clinical Research in Ghana: Accuracy and Reliability of Laboratory Results

Introduction The rising cost of clinical research is driving the current trend of outsourcing to developing countries. Many developing countries, such as Ghana, conduct research but face many challenges in ensuring that the trial conduct and results conform to international standards. Such challenges include staff recruitment and retention and the reliability of laboratory results. Ethical aspects of research are governed by international regulations but policing and enforcing such regulations are less well documented. There are challenges to overcome, including reliability of laboratory results and inadequate resources, with overreliance on those that are adequate. Thus there is a need to develop a research infrastructure that can cope with these challenges. Research should always have laboratory support and those producing results that support international clinical research needs must be accurate and reliable. Evidence of Good Laboratory Practice (GLP) is a regulatory requirement and efforts to show compliance is required. It also is necessary to assure the quality and integrity of data submitted in support of New Drug Applications (NDA), clinical research and marketing permits. The regulation of work in developing countries is often limited due to the absence of a regulatory body to define standards, set policies and assess compliance, resulting in a substandard laboratory service, inaccurate results and a waste of health resources. In Ghana and the West African region, there are many challenges to be faced in the provision of laboratory services, but efforts are being made to address them. In light of this, a project has been undertaken to investigate the current state of these services, the perception of results by users of the service, and provide the opportunity to discuss how regulation can help move the service forward. There is also a perception that laboratory testing is underused in diagnosing infectious diseases, resulting in misdiagnosis and an increased level of mortality.