Background
Clinical trials are research studies performed in people aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people (Vulcano, 2017). Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment (NIH, 2023).
Most of the time clinical trials are conducted to test the safety and efficacy of new drugs, vaccines, medical devices, to test shorter duration of treatment, test a new dosage regimen, minimize side effects, optimize efficacy and safety, before or after marketing authorization (Fekadu et al., 2014).
Clinical trials in Ethiopia and other African nations can considered to be in their embryonic stages. The share of studies registered from Africa is (in Clinicaltrials.gov) updated as of June 2017 is only 0.025%, although the region represents about 15% of the population of the world (Fekadu et al., 2014).
Within Africa, most of the clinical trials are conducted in South Africa (47.3%), which makes one of the largest financial investments on health and has a relatively well-developed health system. Only a limited number of clinical trials are registered from Ethiopia in trial registration sites, representing only 1.5% of all the studies from Africa (Pratt et al., 2012).
Post-trial access (PTA) refers to the ethical imperative that requires the sponsor, researchers, and relevant public health authority, "to make available as soon as possible any intervention or product developed, and knowledge generated, for the population or community in which the research is carried out (Clinical tiral in marketing authorization, 2013) not to mention to research participants who still need the intervention (Declaration of Helsinki, 2013).
The PTA should be planned and documented in the study protocol. The execution plan should be reviewed and updated during the course of the clinical trial. PTA has various aspects. First, it refers to the provision of both knowledge and intervention, if any. Second, it refers to the potential beneficiaries, which could be research participants and/or the intended patient group in the community and/or country. Third, PTA provision to research participants must be free of charge, while PTA for the community and/or host country usually comes in the form of availability and accessibility of the medicinal product within a reasonable time.
Access to an investigational intervention is justified by the principle of beneficence, “which requires researchers and sponsors to safeguard the health of participants when it is in their power to do so.” It is also supported by the principle of distributive justice: participants, and by extension the community or host country, assist researchers in generating valuable data and, in return, researchers should ensure that participants receive needed care to safeguard their health.
Even though the number of clinical trials in LMICs has increased dramatically (Van Roessel et al., 2019), with most of the trials being funded, sponsored, or otherwise influenced by private or public entities from high-income countries, the lack of PTA introduces the risk of exploiting study participants in low and middle-income countries who otherwise have limited access to healthcare.
In this case, national ethics committees and the relevant drug regulation agencies must ensure that PTA is in place. While there is limited practical experience on PTA in clinical trials in LMICs, the concept of benefit-sharing, which acts as the theoretical foundation of PTA, is firmly stipulated in different international ethical guidelines.
The UNESCO Declaration on Bioethics and Human Rights, for example, highlights the duty of benefit-sharing pertaining to scientific and technological innovations, in particular with developing countries (Chirac & Torreele, 2006; UNESCO, 2009);
The Declaration of Helsinki requires the sharing of benefits in medical research with the vulnerable group (Declaration of Helsinki, 2013); and the CIOMS International Ethical Guidelines requires multi-stakeholder cooperation to make the studied intervention and the knowledge gained available to the population or community (CIOMS, 2016).
Hence, ethical guidelines are clear that PTA, in the form of concrete plans and procedures for benefit-sharing and access (may it be in the form of reasonable pricing of an approved indication in the host country, free medicinal product for research participants, the provision of knowledge to the relevant patient population and the community), must be intrinsic to clinical trial planning. Despite these ethical guidelines, the general status quo of PTA is not encouraging: the provision of PTA is “rather the exception than the rule” (Jimenez et al., 2019; Schippe, 2015).
In line with the above principles, this manuscript will explore PTA planning and implementation on TB, Malaria, and NTD clinical trials in Sub-Saharan African countries.
