An expert in Clinical Trials from the University of Nottingham is part of an international team of experts who have come together to enhance clinical trial conduct and reporting.
Paediatric randomised controlled trials provide evidence for patients, families, researchers, clinicians, regulators, funders, policymakers and other interest-holders to inform decisions regarding healthcare interventions and improve outcomes for patients and their families.
The BMJ has teamed up with leading paediatric journals JAMA Pediatrics and The Lancet Child & Adolescent Health to co-publish two papers that will enhance trial conduct and reporting to improve the health of young patients and their families.
The papers provide essential checklist items for researchers to include in clinical trial protocols and reports aimed at enhancing the usefulness, and impact of paediatric randomised controlled trials.
For example, what is the rationale for undertaking the trial in children/adolescents and how will participants' consent be obtained and their confidentiality respected? How will age or development-related differences in treatment effects be addressed, and what impact will trial participation have on the child/adolescent's daily life?
The paper authors say this new guidance will strengthen the quality and safety of the paediatric evidence base, improve health outcomes of children and adolescents, and reduce research and resource waste. Importantly, both guidelines were developed in partnership with young people (ages 10-24 years) and family caregivers.
Professor Ed Juszczak, Professor of Clinical Trials and Statistics in Medicine, Nottingham Clinical Trials Unit, is part of the international collaboration that has produced these new reporting guidelines plus associated Explanation and Elaboration papers.
Ed has a long track record in perinatal clinical trials and has led or co-authored several other similar reporting guidelines. His role on the international steering committee included contributing to discussions around the creation of a long list of prospective items, shortlisting, reviewing the results of the Delphi processes, sourcing examples of good reporting, and dissemination.
While there are many guidelines for the reporting of clinical trials, none up until now, have addressed the unique aspects specific to research involving children and young people. These guidelines should lead to clinical trials that are better designed and conducted, and importantly, reported more transparently. Ultimately this will lead to improved care and outcomes for children, young people and their families in the future."
