This PhD opportunity is being offered as part of the LSTM and Lancaster University Doctoral Training Partnership. Find out more about the studentships and how to apply.
| Abstract | Unlike other clinical trials, involving pregnant women in research is complex and challenging, particularly when assessing the safety and efficacy of medications. Historically, pregnant women have been largely excluded from clinical trials due to real or perceived risks to the woman, the developing fetus, or the infant. As a result, there is limited information available to guide healthcare decisions, despite the widespread use of therapeutic products during pregnancy. While some evidence exists from trials in pregnancy, its robustness is often undermined by a preponderance of low-quality studies. These limitations arise from methodological shortcomings or failure to document key aspects of the interventions. Research has shown that poorly designed, conducted, or reported trials can compromise outcomes, weaken systematic reviews, and negatively influence clinical practice. This study will systematically review clinical trials in pregnancy from the past 20 years to: 1. Assess the reporting quality and trends of RCTs involving pregnant individuals, using the CONSORT statement. 2. Summarize research trends and identify key issues in trial design and conduct (e.g., core outcome definitions). 3. Develop statistical methods for analyzing trial data, which often needs composite outcomes for both mum and child (e.g., Win ratio for composite outcomes). 4. Explore and establish innovative approaches for planning and conducting trials, particularly in global health research. Our findings will outline a framework for improving the planning, conduct, and reporting of clinical trials, providing future recommendations for researchers and funding bodies to enhance global health research in pregnancy. |
| Where does this project lie in the translational pathway? | T3 - Evidence into Practice |
| Expected Outputs | The findings will be compiled into a PhD thesis and disseminated through peer-reviewed journals and presentations at local or international conferences. Potential funding opportunities will be explored through the NIHR's 'Better Methods, Better Research' scheme. |
| Training Opportunities | The core and optional competency modules at Lancaster University will provide essential statistical training required for this project, while knowledge of R can be gained through self-learning. |
| Skills Required | General knowledge in clinical trial with basic research experience in pregnancy would be ideal. |
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Key Publications associated with this project |
Comparison of Clinical Trial Changes in Primary Outcome and Reported Intervention Effect Size Between Trial Registration and Publication |
| 72 weeks post-partum follow-up of dolutegravir versus efavirenz initiated in late pregnancy (DolPHIN-2): an open-label, randomised controlled study | |
| Efficacy and safety of intermittent preventive treatment and intermittent screening and treatment versus single screening and treatment with dihydroartemisinin-piperaquine for the control of malaria in pregnancy in Indonesia: a cluster-randomised, open-label, superiority trial. | |
| A win ratio approach for comparing crossing survival curves in clinical trials |