Can clinical research have a business dimension? SANBio’s most recent Summer School, held on 25-26 February 2018 in Pretoria, brought together 28 students from 10 SADC countries to learn about the business of clinical research from researcher, clinicians and entrepreneurs from around Africa. The course participants relate their experience below.
Most of us had a restricted concept of clinical research when we came to the Business of Clinical Research workshop. The Summer School, facilitated by Dr Emmanuel Nepolo from the University of Namibia, not only answered this question but also gave valuable insight about the economic potential of clinical research. Clinical research as a field extends well beyond just clinical trials; it has the scope to create employment for Africans as clinical leads, research associates, monitors, pharmacists, nurses, community liaisons, project managers, medical writers, biostatisticians, laboratory technicians, and analysts. The path of clinical research that had seemed so narrow suddenly presented a treasure trove of opportunities.
Professor David R. Katerere from Tshwane University of Technology focused on empowering Africa to do its own clinical research. Considering African health challenges and the failure of drug efficacy in African populations, it is now high time to increase research on and for our own people. Precision or personalised medicine is developing appropriate treatments with specific drugs that will work in a given individual or group of people to alleviate their disease. This is in contrast to conventional treatments where drug type, safety and dosage may vary considerably for different individuals.
The workshop focused on modern day clinical research, where cutting edge genomic research is bringing solutions to problems that were never really understood before. Prof Collet Dandara underlined that Africa is the most genetically diverse continent in the world, and that researchers see variable drug responses due to the complex interplay between disease, genes and drug interactions. Encouraging and supporting Africa’s own clinical studies and developing drugs for the African population is now becoming indispensable.
Nathaniel Ramuthaga, a Clinical Research Expert and Business Manager from WITS Clinical Research provided insight into the costs of clinical trials, potential sources of funding and the importance of scientific documentation during the different phases of clinical trials. Dr Dougbeh Chris Nyan of Shufflex Biomed shared his inspiring success story, developing and commercialising an innovative diagnostic kit to detect a panoply of viruses. He remarked that we should not only be happy when we get positive results in research; negative results often lead us to the best possible improvements, which may otherwise never be discovered.
One of the common headaches of research students like us is biostatistical analysis of clinical research data. Associate Professor James Chipeta of University of Zambia emphasised the relevance of proper study design for optimum statistical analysis and validity of research data. Tania Sitoie, National Director of Pharmacy at the Ministry of Health, Mozambique highlighted that the efforts of both the researcher and the different team players within the regulatory bodies of a country can facilitate implementation of ethical and regulatory frameworks in clinical research.
Lastly, clinical researchers are often faced with the dilemma of protecting their research and innovations. Rosemary Wolson from CSIR Licensing & Ventures provided Summer School attendees with an overview of intellectual property in clinical research.
Attendees also visited Synexus, a clinical research centre in Pretoria. Their meticulous patient recruitment process of patients and the numerous controls to ensure high quality standards for all their clinical trials was an enlightening example of clinical research in practice. The site visit brought the lessons of the Summer School into perspective and inspired many students to further advocate for clinical research in other countries of Africa.
Beyond the wide spectrum of talks and presentations, the SANBio Summer School allowed us to interact and network with eminent researchers. Learning from their experiences and that of our peers was an amazing and memorable experience, made even better by the SANBio Annual Event 2018 in the next two days after the Summer School.
- SANBio Summer Schoolers 2018
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