Department of Health Aging and Society, McMaster University, Hamilton, Ontario, L8S 4M4, Canada.
BMC Public Health. 2011 Oct 18;11:811. doi: 10.1186/1471-2458-11-811.
Despite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries.
There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials.
While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.
尽管在中低收入国家（LMICs）进行的临床试验数量有所增加，但对于是否应该在这些国家进行首次人体（FIH；第 0 期和第 1 期）临床试验，以及如果可以进行，应在什么条件下进行，几乎没有进行过认真的讨论。基于我们自己的经验、研究和咨询，本文旨在引发关于我们的观点的辩论，即对于主要针对 LMIC 中最常见疾病的产品，FIH 试验最好首先在这些国家进行。
有科学和实际的论据支持在 LMIC 中进行 FIH 试验。此外，产品开发和监管格局的变化，以及为创新和研究伦理能力建设带来的次要益处，支持了我们的观点。这些观点考虑到在开发进行 FIH 试验的能力的同时，保护研究人类受试者的至关重要性。
虽然 FIH 试验历史上并未在 LMIC 中进行，但这些国家中的一些情况已经发生了变化。因此，我们认为，对于主要针对这些环境中最常见疾病的产品，应在 LMIC 中进行 FIH；只要对人类受试者的必要保护足够充分。
