TY - JOUR
T1 - Expert consensus on novel medicines to prevent preterm birth and manage preterm labour
T2 - Target product profiles
AU - McDougall, Annie R.A.
AU - Tuttle, Andrew
AU - Goldstein, Maya
AU - Ammerdorffer, Anne
AU - Aboud, Lily
AU - Gülmezoglu, Ahmet M.
AU - Vogel, Joshua P.
N1 - Funding Information:
JPV and AMG led the conceptualisation and supervision of the project and were responsible for funding acquisition. AMcD, AT and MG were involved in the conceptualisation of the project and the development of the methodology. AA was involved in the conceptualisation of the project, funding acquisition and project administration. AMcD and LA performed the collection, management, visualisation and analysis of all data. All authors were involved in the interpretation of the data. AMcD wrote the original draft of the article and all authors contributed to writing and editing and had full access to the data. AMcD and JPV have accessed and verified all the data in this study. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Publisher Copyright:
© 2022 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.
PY - 2024/1
Y1 - 2024/1
N2 - Objective: To develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real-world need of women and healthcare providers, informed by views and agreement amongst globally diverse stakeholders. Design: Mixed methods. Setting: Global (with a focus on low- and middle-income countries, LMICs). Sample: Global stakeholders with diverse expertise in preterm labour/birth and drug development. Methods: Following an initial literature review, diverse stakeholders were invited to participate in an online international survey and in-depth interviews. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs. Main outcomes measures: Level of stakeholder agreement on the minimum and preferred requirements for preterm labour/birth medicines. Results: We performed 21 interviews. Interview participants demonstrated strong agreement on room temperature stability, no additional drug-specific clinical monitoring, and affordability in LMICs being the minimal acceptable requirements. Points of discussion were raised around the target population. Survey respondents included clinicians, researchers, funding agency staff, international public organisation staff, programme implementers, policymakers, representatives of consumer advocacy organisations and other relevant stakeholders from maternal health systems. Survey results indicated strong agreement amongst stakeholders, with only one variable in each TPP not reaching consensus (i.e. 25% disagree or strongly disagree). Conclusions: There is strong consensus within the preterm labour/birth community on the characteristics that new medicines for preterm birth prevention and preterm labour management must achieve. These TPPs provide necessary guidance to evaluate new candidates and their potential for implementation in a range of settings.
AB - Objective: To develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real-world need of women and healthcare providers, informed by views and agreement amongst globally diverse stakeholders. Design: Mixed methods. Setting: Global (with a focus on low- and middle-income countries, LMICs). Sample: Global stakeholders with diverse expertise in preterm labour/birth and drug development. Methods: Following an initial literature review, diverse stakeholders were invited to participate in an online international survey and in-depth interviews. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs. Main outcomes measures: Level of stakeholder agreement on the minimum and preferred requirements for preterm labour/birth medicines. Results: We performed 21 interviews. Interview participants demonstrated strong agreement on room temperature stability, no additional drug-specific clinical monitoring, and affordability in LMICs being the minimal acceptable requirements. Points of discussion were raised around the target population. Survey respondents included clinicians, researchers, funding agency staff, international public organisation staff, programme implementers, policymakers, representatives of consumer advocacy organisations and other relevant stakeholders from maternal health systems. Survey results indicated strong agreement amongst stakeholders, with only one variable in each TPP not reaching consensus (i.e. 25% disagree or strongly disagree). Conclusions: There is strong consensus within the preterm labour/birth community on the characteristics that new medicines for preterm birth prevention and preterm labour management must achieve. These TPPs provide necessary guidance to evaluate new candidates and their potential for implementation in a range of settings.
KW - global health
KW - maternal medicines
KW - obstetric medicines
KW - PPROM
KW - spontaneous preterm birth
KW - tocolytics
KW - TPPs
UR - http://www.scopus.com/inward/record.url?scp=85141383786&partnerID=8YFLogxK
U2 - 10.1111/1471-0528.17314
DO - 10.1111/1471-0528.17314
M3 - Article
C2 - 36209501
AN - SCOPUS:85141383786
SN - 1470-0328
VL - 131
SP - 71
EP - 80
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 1
ER -