by Couderc-Pétry M, Eléfant E, Wasunna M, Mwinga A, Kshirsagar NA, Strub-Wourgaft N. PLOS Neglected Tropical Diseases 2020, 14(6): e0008140. doi: 10.1371/journal.pntd.0008140.
Summary: There has been reluctance to include women susceptible to and becoming pregnant (WoSuP) in clinical trials because of the potential risk of exposing the foetus to investigational drugs. However, there is an ethical need for appropriate data on new treatments for any population, including WoSuP, before regulatory approval. One mitigating precaution is to require the use of contraception, however, contraception is not always widely available, culturally allowed, followed, or effective in preventing pregnancy. This paper describes DNDi’s proposal for a safe ethical framework for the recruitment of WoSuP in clinical trials of new drugs against NTDs, which is based on a benefit and/or risk assessment of participation versus nonparticipation.