By Mellisa Mabhikwa – Clinical Study Specialist at GSK representing PPD
Clinical trials are the best way of assessing the safety and efficacy of a clinical intervention. The high burden of disease in Africa calls for more trials to be conducted in this setting, but the capacity to sustainably conduct quality trials now and in the future is under threat.
There is an urgent need for the development of future clinical research professionals who are trained and skilled in conducting rigorous trials to produce data of good quality. This will ensure the continuity of vaccine and drug development in South Africa as the pharmaceutical industry expands. We need to build a culture across the country and indeed the African continent, in which clinical trials are viewed as important and even promoted as they are the gold standard for establishing the safety and efficacy of novel therapies.
Clinical trials in the South African landscape
International clinical trial sponsors favor South Africa as a participating country in multi-center trials because of its genetically diverse, drug-naïve population. Since 1997, the number of applications to conduct clinical trials in SA has grown rapidly. The common threat for approval of some of these applications has been a lack of suitable research sites. The deficiency of competent research sites must be tackled by a strategic plan to improve the capacity of existing sites to conduct quality clinical trials through developing the necessary clinical research skills among health professionals. An increase in the number of trial sites would also increase patient recruitment potential and contribute towards capacity building.
Defining capacity building
Capacity building is defined as an ongoing process of enabling individuals, organizations and industries to do their work in a sustainable manner with continuous improvement over time. To ensure that we have enough qualified and experienced clinical research professionals, we need an orchestrated effort amongst government, sponsors, contract research organizations (CROs) and academia targeted at developing the clinical research skills of young medical doctors and life sciences graduates.
Despite the growth of the industry in the last two decades, clinical research is still not recognized as a specialty with formalized training, other than Good Clinical Practice (GCP), and proven expertise and competence is not assessed. Development of training programs with a core curriculum and an accredited certification process must be prioritized. Such training will certainly improve investor and patient confidence and promote the generation of quality trial data which can be used in decision making regarding new interventions.
According to international standards, a Master’s in Public Health (MPH) is the traditional degree for medical doctors interested in clinical research. In SA, clinical research professionals are required to have a degree in the life sciences plus GCP certification which is renewable every three years. However, GCP training alone is insufficient for competency in clinical research. Academia should get on board by including taught courses in clinical research and drug development.
Trial sites as leaders in capacity building
Existing clinical research centers should offer in-house programs which enable skills sharing among staff of different experience levels. Job specific training to ensure development and consolidation of skills should be supported particularly among recent graduates. Clinical trial sites should ensure that previously disadvantaged members of staff at all levels are given well defined roles that will enhance acquisition of expertise for future involvement in the conduct of clinical trials.
In support of capacity building initiatives in the clinical trials industry, the South African Health Products Regulatory Authority (SAHPRA) requires that all clinical trial applications include a detailed activity plan to develop the skills of previously disadvantaged groups at each participating site. Sites can meet this requirement through implementation of a program which focuses on exposing university students and young graduates in the health and life sciences field to clinical trials. This may include offering traineeships and internships to students and graduates at established clinical research centers.
SA is already a country of choice for many clinical trial sponsors but to ensure continued participation in global trials, a well-trained and experienced workforce needs to be developed. Stakeholders have a responsibility to ensure that previously disadvantaged groups can actively and meaningfully participate in the growing clinical research industry.
About Mellisa Mabhikwa
Mellisa Mabhikwa is a Clinical Study Specialist at GSK representing PPD. She holds a Master of Science in Epidemiology and Biostatistics cum laude from the University of the Witwatersrand and has experience in the conduct and analysis of investigator-led clinical trials.
Disclaimer: All views expressed in this article are my own and do not represent the opinions of any entity whatsoever with which I have been, am now or will be affiliated.