Inclusion of Women Susceptible to and Becoming Pregnant in Preregistration Clinical Trials in Low- and Middle-income Countries: A Proposal for Neglected Tropical Diseases

Overview

Journal PLoS Negl Trop Dis

Specialties Infectious Diseases
Tropical Medicine

Date 2020 Jun 12

PMID 32525876

Citations 6

Authors

Monique Couderc-Petry

Elisabeth Elefant

Monique Wasunna

Alwyn Mwinga

Nilima A Kshirsagar

Nathalie Strub-Wourgaft

Affiliations

Soon will be listed here.

Citing Articles

Incidence and Predictors of Pregnancy in Women Enrolled in Large Multinational HIV Treatment Trials of the AIDS Clinical Trials Group.

Omoz-Oarhe A, Hughes M, Yajing B, Short W, Mngqibisa R, Cohn S J Acquir Immune Defic Syndr. 2023; 94(5):461-467.

PMID: 37820116 PMC: 10811622. DOI: 10.1097/QAI.0000000000003299.

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials: A Systematic Review and Meta-analysis.

Xiao H, Vaidya R, Liu F, Chang X, Xia X, Unger J JAMA Intern Med. 2022; 183(1):50-60.

PMID: 36469312 PMC: 9857303. DOI: 10.1001/jamainternmed.2022.5600.

Recruitment of pregnant women to randomised trials of COVID 19 treatments, and pharmaceutical treatments received outside such trials: A research article.

Green O, Young E, Oberman J, Stewart J, King Y, ODonoghue K Eur J Obstet Gynecol Reprod Biol. 2022; 275:12-16.

PMID: 35696831 PMC: 9106591. DOI: 10.1016/j.ejogrb.2022.05.009.

Development and Introduction of Fexinidazole into the Global Human African Trypanosomiasis Program.

Valverde Mordt O, Tarral A, Strub-Wourgaft N Am J Trop Med Hyg. 2022; 106(5_Suppl):61-66.

PMID: 35292581 PMC: 9154641. DOI: 10.4269/ajtmh.21-1176.

Visceral Leishmaniasis in pregnancy and vertical transmission: A systematic literature review on the therapeutic orphans.

Dahal P, Singh-Phulgenda S, Maguire B, Harriss E, Ritmeijer K, Alves F PLoS Negl Trop Dis. 2021; 15(8):e0009650.

PMID: 34375339 PMC: 8425569. DOI: 10.1371/journal.pntd.0009650.

References

Bangasser D, Valentino R . Sex differences in stress-related psychiatric disorders: neurobiological perspectives. Front Neuroendocrinol. 2014; 35(3):303-19. PMC: 4087049. DOI: 10.1016/j.yfrne.2014.03.008. View

Uhl K, Parekh A, Kweder S . Females in clinical studies: where are we going?. Clin Pharmacol Ther. 2007; 81(4):600-2. DOI: 10.1038/sj.clpt.6100112. View

Liu K, DiPietro Mager N . Women's involvement in clinical trials: historical perspective and future implications. Pharm Pract (Granada). 2016; 14(1):708. PMC: 4800017. DOI: 10.18549/PharmPract.2016.01.708. View

Christian M . Introduction/overview: gender-based differences in pharmacologic and toxicologic responses. Int J Toxicol. 2001; 20(3):145-8. DOI: 10.1080/109158101317097719. View

. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013; 310(20):2191-4. DOI: 10.1001/jama.2013.281053. View

Coleman C, Ardiot C, Blesson S, Bonnin Y, Bompart F, Colonna P . Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis. Dev World Bioeth. 2014; 15(3):241-7. DOI: 10.1111/dewb.12068. View

Sampson M, Benjamin D, Cohen-Wolkowiez M . Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health. Expert Rev Clin Pharmacol. 2012; 5(5):525-31. PMC: 3566240. DOI: 10.1586/ecp.12.52. View

Stadler J . [Developmental and reproductive toxicology: interest and interpretation]. Therapie. 2014; 69(1):25-30. DOI: 10.2515/therapie/2014010. View

Bartlett E . Recruitment of women into trials. Lancet. 2002; 359(9301):165. DOI: 10.1016/S0140-6736(02)07343-9. View

10.

Macklin R . Enrolling pregnant women in biomedical research. Lancet. 2010; 375(9715):632-3. DOI: 10.1016/s0140-6736(10)60257-7. View

11.

Schofield C, Jannin J, Salvatella R . The future of Chagas disease control. Trends Parasitol. 2006; 22(12):583-8. DOI: 10.1016/j.pt.2006.09.011. View

12.

Allesee L, Gallagher C . Pregnancy and Protection: The Ethics of Limiting a Pregnant Woman's Participation in Clinical Trials. J Clin Res Bioeth. 2011; 2(108). PMC: 3158978. DOI: 10.4172/2155-9627.1000108. View

13.

Trussell J . Contraceptive failure in the United States. Contraception. 2011; 83(5):397-404. PMC: 3638209. DOI: 10.1016/j.contraception.2011.01.021. View

14.

Salas N, Cot M, Schneider D, Mendoza B, Santalla J, Postigo J . Risk factors and consequences of congenital Chagas disease in Yacuiba, south Bolivia. Trop Med Int Health. 2007; 12(12):1498-505. DOI: 10.1111/j.1365-3156.2007.01958.x. View

15.

Tabi M . Community perspective on a model to reduce teenage pregnancy. J Adv Nurs. 2002; 40(3):275-84. DOI: 10.1046/j.1365-2648.2002.02369.x. View

16.

Lyerly A, Little M, Faden R . The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2009; 1(2):5-22. PMC: 2747530. DOI: 10.1353/ijf.0.0047. View

17.

Curry 3rd B . Animal models used in identifying gender-related differences. Int J Toxicol. 2001; 20(3):153-60. DOI: 10.1080/109158101317097737. View

18.

Czerniak R . Gender-based differences in pharmacokinetics in laboratory animal models. Int J Toxicol. 2001; 20(3):161-3. DOI: 10.1080/109158101317097746. View

19.

Omer S, Beigi R . Pregnancy in the Time of Zika: Addressing Barriers for Developing Vaccines and Other Measures for Pregnant Women. JAMA. 2016; 315(12):1227-8. DOI: 10.1001/jama.2016.2237. View

20.

Bloom T . A question of evidence. BMJ. 2016; 355:i6316. DOI: 10.1136/bmj.i6316. View