Research Methods Research
Clinical practice guidelines are only as good as the studies that inform them. There is an urgent need to increase the number and quality of clinical pharmacology studies in maternal-child health. Innovative and adaptive methods are needed to efficiently answer important research questions.
Dr. Kelly participates in several international expert groups on clinical research methods including, but not limited to:
The Maternal-Infant Child and Youth Research Network KidsCan Trials Steering Committee https://www.kidscantrials.ca/
The Collaborative Network for European Clinical Trials for Children https://conect4children.org/ in the Pharmacovigilance Expert Group
The International Society for Pharmacoepidemiology, Pediatric Special Interests Group https://www.pharmacoepi.org/communities/sigs/pediatrics/
On November 10th, 2022, Dr. Lauren Kelly presented Pediatric Grand Rounds at the University of Saskatchewan on clinical trials. You can watch the presentation here.
Previously Published Work
This review summarizes practical strategies to address current challenges, particularly the use of model-based (pharmacometric) approaches in study design and analysis. Recommendations for practice and directions for future paediatric pharmacological research are given, based on current literature and our joint international experience.
We aimed to determine the proportion and adequacy of clinical trial registration in pediatric surgery trials published in 2014.
For 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints.
This study will deliver practical recommendations on the use of AD in pediatric CTs. Collaboration and consultation with national and global partners will ensure that our results meet the needs of researchers, regulators, and patients, both locally and globally, and that they remain current and relevant by engaging a wide variety of stakeholders.
InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.
We evaluated 300 paediatric trials to determine: the consent and recruitment strategies used, who trial information was targeted to, how incentives were used and if they achieved their recruitment targets.
This article discusses the selection of an appropriate measure of response, the PD endpoint, which is a critical methodological step in designing pediatric efficacy and safety studies
To promote drug development for neonates, the pharmaceutical industry is moving toward rigorous testing, necessitating the need to development, and validating biomarkers in neonates to predict their response. The objective of this review is to evaluate the quality of the response biomarker reporting in neonatal clinical trials.
The value of comparative effectiveness trials in informing clinical and policy decisions depends heavily on the choice of control arm (comparator). Our objective is to identify challenges in comparator reasoning and to determine justification criteria for selecting a control arm in paediatric clinical trials
The objective of our study was to evaluate intervention and “standard of care” control arms reported in published pediatric clinical trials