Dr. An-Wen Chan
Randomized clinical trials guide how your doctor practises medicine. But in recent years it has become increasingly clear that biased and poorly designed trials are an endemic problem, and their results can’t be trusted.
“Trial protocols and existing protocol guidelines vary enormously in content and quality,” explains Dr. An-Wen Chan. “Some protocols are shockingly brief and provide very little solid information about the trial.”
Yet protocols are the building blocks of the entire study, guiding its planning, conduct, reporting and appraisal. “It’s a dangerous situation that puts patients at risk and wastes healthcare dollars,” says Chan.
To improve trials, Chan has developed an evidence-based checklist to guide scientists as they plan their trial, and to help them keep the study on-track and accountable to produce defensible results. In January 2013 it was published in two high-impact journals – the Annals of Internal Medicine and BMJ. Chan’s commentary appeared in the Lancet.
Trial protocols and existing protocol guidelines vary enormously in content and quality. Some protocols are shockingly brief and provide very little solid information about the trial.
The checklist will lead to higher quality research results that better support physician decision making – and patients’ health and safety. It provides 33 recommendations for the minimum key content that should be detailed in a clinical trial protocol. It will not only guide scientists, but will also be useful for ethics committees, funders and journal review panels.
THE POWER OF MANY
An-Wen Chan is harnessing the power of many by building strong ties throughout our international community to collectively promote transparency in research.
- Chan chairs the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) group, an international panel of experts from Canada, the U.S., the U.K. and Europe, which is funded by the CIHR, the National Cancer Institute of Canada and the Canadian Agency for Drugs and Technologies in Health.
- The SPIRIT group recently published the SPIRIT 2013 Statement in Annals of Internal Medicine, providing a systematically developed 33-item checklist of minimum key items that should be detailed in a trial protocol. It has also published the SPIRIT 2013 Explanation and Elaboration in BMJ, to detail the rationale and provide supporting evidence for each checklist recommendation, and SPIRIT: New Guidance for Content of Clinical Trial Protocols in the Lancet, to discuss the impact of evidence-based guidance on trial quality and efficiency.
- The SPIRIT guidance has been widely endorsed internationally by research groups, institutions, medical journals, industry, patient groups and academic institutions.