Women's College Research Institute

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Innovative research tool aims to improve patient safety

February 2013

Dr. An-Wen ChanDoctors base their treatment decisions on the results of research studies that aren’t producing reliable data, according to Dr. An-Wen Chan, Phelan scientist at Women’s College Research Institute and dermatologic Mohs surgeon at Women’s College Hospital.

“It’s a dangerous situation that puts patients at risk and wastes health-care dollars,” says Chan, who is also an assistant professor of Medicine at the University of Toronto and cross-appointed to the University of Toronto’s Institute of Health Policy, Management and Evaluation.

The quality of data generated by a clinical trial is rooted in the trial’s protocol, which is the foundation for the entire study, including its planning, conduct, reporting and appraisal.

“But trial protocols and existing protocol guidelines vary enormously in content and quality,” explains Chan. “Some of the protocols I’ve reviewed are shockingly brief and provide very little solid information about the trial. Yet these documents are the building blocks of the entire study.”

Chan is working to improve trial protocols, which will lead to higher quality research results that better support physician decision making – and patients’ health and safety. He’s developed an evidence-based checklist as a tool to help scientists plan their trial and keep it on-track from the start, to help ensure the results are trustworthy.

The SPIRIT checklist provides 33 recommendations for the minimum key content that should be detailed in a clinical trial protocol. It will guide scientists, and serve as a useful guide for research ethics committees, funding agencies, and journal review panels to promote high-quality protocols.

In January, the checklist was published in two high-impact journals – the Annals of Internal Medicine and BMJ. Chan’s commentary about the checklist was also published in the Lancet in January.

“It’s human nature for the scientific community to be much more excited by positive results. But of course we also want to publish solid findings,” says Chan.

“The checklist will help scientists build protocols that stand up to scrutiny,” says Chan. “It will ultimately support a higher quality of clinical trial data that doctors and patients can rely on.”


SPIRIT, which stands for Standard Protocol Items: Recommendations for Interventional Trials, is an international panel of experts that is chaired by Dr. An-Wen Chan. SPIRIT is funded by the Canadian Institutes of Health Research, the National Cancer Institute of Canada and the Canadian Agency for Drugs and Technologies in Health. Visit www.spirit-statement.org for more information.

The SPIRIT 2013 Statement, published in Annals of Internal Medicine, provides a systematically developed 33-item checklist of minimum key items that should be detailed in a trial protocol.

The SPIRIT 2013 Explanation and Elaboration, published in BMJ, provides important information to promote full understanding of the checklist recommendations, detailing the rationale and supporting evidence for each checklist item, and providing guidance and model examples from actual protocols.

SPIRIT: New guidance for content of clinical trial protocols, published in the Lancet, is a comment that discusses the need for evidence-based guidance for protocol content and the potential impact of SPIRIT on clinical trial conduct and review.

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