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Gary Evans writes Hospital Infection Control & Prevention (HIC), Hospital Employee Health (HEH) and contributes to IRB Advisor (IRB). As senior writer at AHC, Evans has written numerous articles on infectious disease threats to both patients and health care workers, including pandemic influenza, MERS and Ebola. He has been honored for excellence in analytical reporting five times by the National Press Club in Washington, DC.
Originally founded in the UK, the AllTrials Campaign – a varied group of patient advocates, medical associations and academia – have brought their crusade for clinical trial transparency to the United States with the recent launch of their website.
They begin with the rather stunning but fully referenced assertion that some 50% of all clinical trials, involving hundreds of thousands of patients, have never reported results.1,2 While acknowledging that the situation has improved in recent years, they emphasize there is a veritable iceberg’s bottom of stats and studies that have never seen the light of day.
“We need the results of past trials, and urgently, because these are the trials that were done on the treatments that patients use today and will probably continue to use for many years to come,” the group states on their website.
Among the 50 U.S. groups that signed on in support of the U.S. launch of AllTrials – they have 600 globally -- is the American Academy of Family Physicians (AAFP), the only medical society devoted solely to primary care.
“If there is data or the results of a test is not favorable or what you expected maybe you don’t publish it, but that can be useful information too,” says Robert Wergin, MD, president of the AAFP. “That’s where the transparency comes in. I am a practicing physician in a rural community so I rely on the outcomes of many of these clinical trials to formulate my best treatment plan for a particular patient. If there are trials or evidence that shows me my treatment plan is not the best I would certainly like to alter that. So transparency is a useful thing and some of the [medical] discoveries we have made, and some of the bigger changes we’ve made, were almost an indirect outcome of another study [looking for something else]. Transparency results in more evidence to build the best possible treatment plans for patients.”
1. Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technology Assessment 2010;14:8:1-93. http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0005/64751/FullReport-hta14080.pdf
2. Ross JS, Mulvey GK, Hines EM, et al. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis. PLoS Medicine 2009;8;6:e1000144.
For more on this story see the Oct. 2015 issue of IRB Advisor
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