SANBio Summer School: the Business of Clinical Research

SANBio Summer School participants

The SANBio Summer School on the Business of Clinical Research was held on 25-26 February 2018 in Pretoria. The event, just prior to the SANBio Annual Event, saw 28 students from 10 SADC countries engage with and learn from experts in the clinical research field. This article was written by the course participants.

Can clinical research have a business dimension? Most of us had a restricted concept of clinical research when we came to the Business of Clinical Research workshop on 25-26th February 2018 in Pretoria. The SANBio Summer School, facilitated by Dr Emmanuel Nepolo from the University of Namibia, not only answered this question but also gave valuable insight about transforming the economics of Clinical Research. The latter extends well beyond just clinical trials and has the scope of creating 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 some of us had considered so narrow, was turning out to be a treasure trove of opportunities.

Empowering Africa for its own clinical research was a prime topic highlighted by Prof David R. Katerere from Tshwane University of Technology. Considering the increasing health problems and failure of drugs in terms of efficacy among the African population, it is now high time to increase research on our own population. Precision medicine is helping to design the appropriate treatment with specific drugs that will work in a given individual or group of people to alleviate their disease rather than going for conventional treatments where drug type, safety and dosage may vary considerably for different individuals.

The new paradigm presented in the workshop is highly relevant and applicable to 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 addition, a high variation in response to drugs has been observed due to the complex interplay between disease, genes and drug interaction. Hence, encouraging Africa’s own clinical studies and developing its own range of drugs is now becoming indispensable.

A deeper insight into the costs involved in clinical trials, potential sources of funding and the importance of scientific documentation during the different phases of clinical trials was given by Nathaniel Ramuthaga, a Clinical Research Expert and Business Manager from WITS Clinical Research. One of the major inspiring success stories came from Dr Dougbeh Chris Nyan of Shufflex Biomed, LLC. He remarked that we should not only be happy when we get positive results in research as negative results often lead us to the best possible improvements otherwise never envisaged. The development and commercialisation of an innovative diagnostic kit for detection of a panoply of viruses was a result of the persistent efforts of Dr Nyan – this being a practical example of integrating entrepreneurship and clinical research.

One of the common headaches of research students like us is the stage of biostatistical analysis. The relevance of a proper study design for optimum statistical analysis and adequate validity of research data was emphasised by Ass. Prof James Chipeta of University of Zambia. Moreover, how 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 framework in clinical research, was given as an example by Tania Sitoie, National Director of Pharmacy at the Ministry of Health, Mozambique.

Lastly, clinical researchers are often faced with the dilemma of protecting their research and innovations. An extensive overview on intellectual property in clinical research was given by Rosemary Wolson from CSIR Licensing & Ventures.

The workshop also gave us the opportunity to further garner knowledge at Synexus, a clinical research centre in Pretoria. Their meticulous recruitment process of patients and the numerous control check points to ensure high quality standards for all their clinical trials, was exemplary. The site visit at Synexus brought all the knowledge gathered into perspective and was an inspiration for us 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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