African Congress for Clinical Trials
Lambaréné, 10-14 November 2019 (2nd edition)
Clinical trial in Sub-saharan Africa : Challenge or Opportunity ?
1st Day of scientific activities
The day started on October 09, 2018 at 09:00 am with a session reporting on the current situation on clinical trial practices in sub-Saharan Africa.
This review revealed that the number of clinical trials conducted on the continent has been constantly increasing since 1960, and that activity has been structured and expanded over time. Most of the clinical trials conducted on the continent are conducted through international collaborations with Western academic institutions and pharmaceutical companies. It appears that the latter design, register, finance and carry out the most complex tasks (laboratory tests, statistical analyses, etc.). Also, these institutions are most of the time the "owners" of the clinical trials conducted in sub-Saharan Africa. Similarly, the first authors of the scientific articles with a high scientific impact and therefore a high potential to influence health decisions and policies, as well as the production of health goods, are most often the researchers from these Western institutions.
Furthermore, there are regional discrepancies in sub-Saharan Africa, with clinical trials activities much more developed in South and East Africa, moderate in West Africa and at a lower level in Central Africa.
The rest of the day remained scientifically significant with the review and update of knowledge about the involvement of parasitic infections in the carcinogenesis process and the occurrence of cancer in humans.
Some scientific communications have reported the evaluation of laboratory tests for the diagnosis of parasites in saliva, as well as molecular and immunological tests for the diagnosis of viral diseases. Some others have identified study protocols, difficulties in implementing antimalarial and anti-tuberculosis therapeutic clinical trials.
The discussion panel on the first day stressed the need to establish permanent interactions between the stages of health goods discovery and their development, on the one hand, and the necessary and vital "intrusion" of the clinical trial practice into the uses of the African pharmacopoeia, on the other.
Finally, the working lunch of the day - upon invitation - resulted in the manifesto for the creation of an African Clinical Trials Society: academic, scientific, technical and promotional framework for clinical trials and the acceleration of the development of high potential health goods to address health issues in sub-Saharan Africa.
2nd Day of scientific activities
The second day began with talks on the safety and immunogenicity of vaccine candidates under development. Regarding the Ebola vaccine candidate rVSV-ZEBOV, discussions focused on the potential effects of the rVSV vector to induce/boost non-specific circulating antibodies against viruses other than Ebola.
For the vaccine candidates VARCSA2-ID1-ID2 (against placental malaria in pregnant women), Na-APR-1 M74/alhydrogel and Na-GST-1 M74/alhydrogel (against hookworm infection due to Necator americanus) and GMZ2 (against malaria), specific immune responses and safety were presented. All of these have induced encouraging immune responses and acceptable safety profiles.
Regarding molecular and immunological techniques, the presentations focused on the characterization of cytochrome genetic diversity in the African subject and their identification in the context of pharmacovigilance; surveillance of antimalarial chemoresistance and immunological techniques for appropriate measurement of humoral responses to plasmodium infection and following administration of an antimalarial vaccine.
The discussion panel focused on the compliance of research with existing regulations in sub-Saharan Africa, for example in Gabon. We noticed misunderstandings, lack of communication, and the need to take into account the environment and international standards.
During the working lunch, it was explained to the guests how informed consent in trans-national clinical trials are performed. Issues related to the linkage of international standards to the national legal and regulatory framework, as well as cultural, social and economic factors, were also discussed. For example, without a clear national - or even African - legal framework, informed consent is more likely to protect Western partners from their countries' laws than to convey information accessible to the African participant. Similarly, assent (the expression of the child's willingness to participate, in addition to the consent of the parent) has been given little or no consideration by African societies. Therefore, the age of consent may vary from one clinical trial to another, depending on the origin of the Western partner.
The participants unanimously decided to entrust the future African Clinical Trials Society with the project to standardize practices related to informed consent and assent.
3rd Day of scientific works
On the fourth and final day, the progress of research for diagnostic, therapeutic and preventive measures against Ebola virus was the focus of the Congress attendees.
In addition, health economists presented the funding sources and mechanisms for biomedical research in Gabon. Demographers presented a demographic and health monitoring system in Lambaréné region and its potential uses in the fields of biomedical research and public health interventions.