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About Sickkids
About SickKids

June 1, 2012

StaR Child Health launches first international standards for clinical trials in children

Standards could fast-track research results and bring treatment to patients sooner

Researchers have developed new clinical trial standards to help speed up research process, improve patient treatment and focus international efforts with the goal of impacting child health in Canada and around the world. The initial standards are published in the June 1 edition of Pediatrics.

When the available treatment options are not working, children and adults are sometimes offered new therapies that are still being studied and tested. These clinical trials not only give patients access to treatment that would not otherwise be available to them, but they also help to advance scientific discoveries that may eventually benefit more patients.  

While internationally-accepted standards for adult clinical trials have been implemented, practices in paediatric trials vary from institution to institution. Differences in study design, data-monitoring and measurement make it a challenge to effectively compare results, which means it takes longer for research to translate into clinical care.  

To tackle this issue an international group of researchers, methodologists, practitioners, regulators and journal editors formed Standards for Research (StaR) in Child Health. This initiative seeks to develop practical and evidence-based guidance to enhance the reliability and relevance of paediatric clinical research.

“If all researchers used the same standards, research discoveries could become treatments much faster. We could shave years off the research process,” says Dr. Martin Offringa, co-lead of StaR Child Health Group and Senior Scientist and Head of the Child Health Evaluative Sciences Program at The Hospital for Sick Children (SickKids).

“Ultimately, we want the child to be safe and their contribution to be meaningful,” says Offringa. “Clinical trials provide patients and families with an opportunity to try alternative treatment options while also allowing researchers to learn from the results and directly impact the care of future patients.”

Offringa explains that there needs to be more guidance about appropriate sample size, the measurement of health outcomes, monitoring the data, and age-specific issues in clinical trials, to name a few. For example, there was once the attitude that the more participants in the trial the better, “our research tells us that is not the case. We know now that there is an optimal number of clinical trial participants for each clinical research question. Not too few, not too many,” says Offringa.

“Uniform clinical trials standards will allow researchers to pool their knowledge, and share their findings more easily. This will have a direct impact on the care of sick children, and the future of paediatric research,” says Dr. Terry Klassen, co-lead of StaR Child Health and Director of Research at the Manitoba Institute of Child Health. “We want to provide sick children with the best possible treatments. In order to provide treatments that are effective and safe we need to study them, and this is a very delicate process.”

Research shows that children who participate in clinical trials often receive better care and have better outcomes because they are more closely monitored, not only by clinical staff and but also their parents who, in many cases, are required to systematically report on any changes in their child and how they are feeling on a daily basis. If important changes are noted, then adjustments to the treatment are made immediately.

The StaR Child Health clinical trial standards were formed based on scientific research into the design, conduct and evaluation of clinical trials. To date, approximately 180 scientific and medical participants, including representatives from the World Health Organization (WHO), the US Food and Drug Administration, the European Medicines Agency, and a number of leading medical journals have contributed to the development of the standards.

These standards provide a clear manual to researchers about how to avoid errors. Something as simple as a checklist can really improve outcomes.

So far standards have been developed for six out of 11 priorities in clinical trials. Offringa and Klassen say that the next step will be to implement the StaR Child Health standards in paediatric research institutes across the globe.

About The Hospital for Sick Children
The Hospital for Sick Children (SickKids) is recognized as one of the world’s foremost paediatric health-care institutions and is Canada’s leading centre dedicated to advancing children’s health through the integration of patient care, research and education. Founded in 1875 and affiliated with the University of Toronto, SickKids is one of Canada’s most research-intensive hospitals and has generated discoveries that have helped children globally.  Its mission is to provide the best in complex and specialized family-centred care; pioneer scientific and clinical advancements; share expertise; foster an academic environment that nurtures health-care professionals; and champion an accessible, comprehensive and sustainable child health system. SickKids is proud of its vision for Healthier Children. A Better World. For more information, please visit www.sickkids.ca.

About Manitoba Institute of Child Health (MICH)
Established in 2001, the Manitoba Institute of Child Health is the research division of the Children's Hospital Foundation of Manitoba. It is the only research institute dedicated exclusively to paediatric research in the Prairie Provinces. At the Institute, over 270 world-class pediatric medical researchers, technical staff, students and support staff are involved in over $8 million of research and clinical trial activity each year. For more information, please visit www.mich.ca.

For more information, please contact:

Caitlin McNamee-Lamb
The Hospital for Sick Children
Phone: 416-813-7654 ext. 1436
email: caitlin.mcnamee-lamb@sickkids.ca