Creation of a drug fund for post-clinical trial access to antiretrovirals

Conduct of clinical trials in developing countries: a perspective

“…Finally, it is to be emphasized that posttrial access cannot be denied in situations in which the discontinuation of intervention will harm the patient, when there is no alternative way to access the newer therapy beyond the study period and the participant information sheet states that posttrial medication will be provided [19]. An excellent example for managing funds for posttrial medication is provided by the work of HIV-Netherlands, Australia, Thailand Research Collaboration group (HIV-NAT), who made antiretroviral (ARV) therapy available for all the participants using innovative funding mechanisms [21]. However, a drug fund is only a temporary solution, and the ultimate goal will be to make the treatment available for routine healthcare, which is beyond the scope of this article.…”

Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

“…Several authors have suggested that trial sponsors should assume at least some responsibility for providing posttrial services 5,6,16,28. Important roles for investigators, local organizations, and national governments have also been proposed,6,7,15,28 with or without sponsor financial support to create enduring local health care capacity 9. The extent of sponsor obligation may depend on whether the sponsor is a government agency or a for-profit entity, which might be expected to have greater financial capacity to provide posttrial services 27.…”

“…The ethical debate has included divergent opinions regarding three primary issues: (1) whether receipt of posttrial services constitutes a fair benefit or an undue inducement to research participants,1–4 (2) whether providing posttrial services unfairly prioritizes research participants over other community members,5–7 and (3) whether an obligation to provide such services creates an excessive burden for trial sponsors, thus reducing their incentive to conduct research 5,6. In addition, particularly for trials conducted in resource-limited settings, it has been suggested that local governments and non-governmental organizations may be better suited than trial sponsors to provide posttrial services 7–9…”

Should post-trial provision of beneficial experimental interventions be mandatory in developing countries?

“…These benefits usually include improving the quality and infrastructure of healthcare, developing the skills and expertise of local scientists and health professionals, increasing job opportunities, promoting economic development and promulgating health knowledge 1 7 17. In addition, some commentators point out that provision of short-term interventions during the research period is better than nothing for those in poor nations who have no access to necessary healthcare 21. However, it is quite clear that basic ethical principles such as those described by the Belmont Report should be followed in all trials involving human subjects no matter where they are carried out.…”

“…In the model of the comprehensive partnership, the ERC or IRB approves the post-trial arrangements, the sponsor organises post-trial provision, the local healthcare system delivers and monitors it with the help of investigators, the patient advocacy group provides consultation, and participants are actively involved in post-trial interventions by complying with the post-trial protocols, attending regular follow-ups, reporting possible adverse events and so on. As King21 pointed out, the partnership model can be established and concerns raised by different sides can be overcome with careful planning. In my opinion, as for the duration of post-trial provision, it should be continued as long as the participant still needs it but have no access to it or equivalent alternatives from the regular health system.…”