The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy.
OBJECTIVE
To undertake a survey of the world's clinical trial registries to provide current data on the number, nature, funding source and geographical distribution of pregnancy drug trials (PDT).


METHODS
Comprehensive analysis of WHO-certified clinical trial registries.


METHODS
Sixteen registries containing 301 538 trials (168 826 active in 2013-2014) were analysed to identify the numbers, location, funding sources, and areas of interest/development of PDTs.


RESULTS
The percentage of PDTs varied from 0 to 7.4% across registries. Overall, just 0.32% (534) of all active registered studies were PDTs. The US registry (Clinicaltrials.gov) was the largest database, but contributed just 14% of all active PDTs. The majority of PDTs focused on anaesthesia/analgesia, preterm birth/tocolysis, labour induction, endocrine and hypertensive disorders. Less than 6% of active PDTs focused on maternal or fetal health as a specific primary outcome, and only 4.4% included a preplanned pharmacokinetic analysis of the trial medications. A third of all active PDTs involved repurposing of existing medicines for applications in pregnancy, whereas only three new investigational drugs had been developed for a pregnancy indication. Seven percent of all active PDTs identified were pharmaceutical industry-funded. Inter-disease comparisons identified a ~50-fold disparity in trial activity between pregnancy and other comparable areas.


CONCLUSIONS
This study demonstrates unequivocally the marked under-representation of medication development, evaluation and safety trials in pregnancy. The likelihood that the current pharmaceutical landscape in pregnancy will improve in the foreseeable future is slim. Advocacy and increased awareness of the issue is necessary to achieve positive change.


CONCLUSIONS
Pregnant women are significantly under-represented in global clinical drug trials.
King Edward Memorial Hospital, Subiaco, Perth, WA, Australia.
J
J
Scaffidi
Department of Obstetrics & Gynaecology, Robinson Research Institute, University of Adelaide, Adelaide, SA, Australia.|The South Australian Health and Medical Research Institute, Adelaide, SA, Australia.
B W
BW
Mol
School of Women's and Infants' Health, King Edward Memorial Hospital, University of Western Australia and Women and Infants Research Foundation, Subiaco, Perth, WA, Australia.
J A
JA
Keelan
D000698:Analgesia / Q000379:methods; D000758:Anesthesia / Q000379:methods; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D005260:Female; D014943:Global Health; D006801:Humans; D019365:Metaphor; D009774:Obstetrics; D009965:Orphan Drug Production; D011247:Pregnancy; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000188:drug therapy*; D012042:Registries; D011795:Surveys and Questionnaires; D015145:Tocolysis / Q000379:methods; D015149:Tocolytic Agents / Q000627:therapeutic use*
D015149:Tocolytic Agents
Clinical trials; drug development; drug safety; pharmaceuticals; pregnancy