Research is necessary to identify safe and effective treatments and vaccines for emerging infections like Covid, but there are often misconceptions about why, how and where research is carried out.
The “gold standard” for research into new treatments and vaccines is the randomized clinical trial (RCT). There are several variations on a trial, but the underlying principle is the same: groups of volunteer participants are randomly allocated to receive one or more different treatments. This basic structure allows researchers to evaluate how well a treatment or a vaccine works, and to make sure that it is not causing any unexpected harm.
In the past, there have been examples of research being carried out in unethical ways, including by Nazi physicians in concentration camps and by American researchers knowingly withholding treatment for syphilis in a group of African-American men. Public recognition that these practices are unethical and morally unacceptable has led to a variety of safeguards to be put into place.
- Most notably, the Declaration of Helsinki has set forth the basic principles necessary for the ethical conduct of clinical research.
- Standards for the conduct of clinical trials have been laid out in the International Conference on Harmonization’s guidelines for Good Clinical Practice.
- Trial procotols are reviewed by one or more independent Ethical Review Committees whose members are charged with safeguarding the well-being of study participants
One of the most important aspects of clinical research is that participants must give their informed consent to participate in the research. This is a formal process that involves discussions with the research team, and review of written materials that clearly outline the risks and potential benefits of participating in the research study, the fact that there are no penalties for choosing not to participate, and that a participant can withdraw from a study at any time without having to give an explanation. This informed consent process and all written documents are closely reviewed by Ethical Review Committees before a study can be allowed to start.
Special care must be taken when research is performed in vulnerable populations, including children, pregnant women, prisoners, and persons who are otherwise at risk, or perceived to be at risk, of undue exploitation.
At Epicentre, we have been conducting clinical trials in Africa for over 15 years, and believe that it is essential to continue doing so, but underscore that research done in low-resource settings in Africa must be held to the same scientific and ethical standards than studies performed in higher-resource settings.
For any condition, it is important to test potential treatments or vaccines in the populations that stand to benefit from them. Ebola vaccines should undergo trials in populations that are at risk of Ebola, malaria drugs should undergo trials in populations where malaria is a major health problem. Covid is currently spreading across Africa. And while some lessons may be learned from trials in other settings, it will be important to ensure that scientifically sound and ethically rigorous research is conducted on Covid treatments and vaccines in Africa, too.
Epicentre has conducted research in a variety of emergency and epidemic settings, including on vaccines for Ebola (Guinea, DRC, Uganda), treatments for Ebola (DRC), vaccines against rotavirus (Niger), nutrition (Niger and Nigeria), vaccines for cholera (Guinea and others) treatments for meningococcal meningitis (Niger, Mali).
Epicentre aims to take part or even sponsor trials where the pharmaceutical company is not the sponsor.
Find out more
- JAMA article by André Kalil « Treating COVID-19—Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics »
- Fred Eboko, Le Monde Afrique « Non, l’Afrique n’est pas, ni de près ni de loin, la cible privilégiée des essais cliniques »