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http://www.virology.ws/2018/02/19/trial-by-error-a-letter-to-bmj-open/
Trial By Error: A Letter to BMJ Open
19 FEBRUARY 2018
By David Tuller, DrPH
Trial By Error: A Letter to BMJ Open
19 FEBRUARY 2018
By David Tuller, DrPH
Three weeks ago, Professor Racaniello e-mailed a letter of concern to Archives of Disease in Childhood about its recent study of the Lightning Process as a treatment for ME/CFS in kids. The journal’s editor, Dr. Nick Brown, answered within an hour, assuring Professor Racaniello that he took the matter seriously and that the journal would review the issue. I understand that this process can take time, and I look forward to the response.
In the meantime, I followed up with Dr. Brown over the weekend, after an observant patient alerted me to an interesting statement on the BMJ website. As a BMJ journal, Archives of Disease in Childhood promises on its website to adhere to the organization’s policies and refers readers to the BMJ Author Hub for further information. This hub includes a page about clinical trial registration.
Here’s the key passage: “In accordance with the ICMJE [International Committee of Medical Journal Editors] Recommendations, BMJ will not consider reports of clinical trials unless they were registered prospectively before recruitment of any participants. This applies to trials which commenced after 1 July 2005.”
In my e-mail to Dr. Brown, I noted that the Lightning Process study violated this explicit policy about prospective trial registration. In the study, more than half the subjects were feasibility study participants who were recruited before the official trial registration date—in some cases almost two years before. Therefore, the trial was clearly not registered “before recruitment of any participants,” as required per BMJ’s stated policy.