By David Tuller, DrPH
Earlier today I sent the following letter to the e-mail address I found at the website of Red Whale/GP Update, which recently disseminated a recruitment ad for FITNET-NHS. I blogged about it on Monday. I cc’d officials at the Health Research Authority, the agency that regulate research ethics.
Dear Red Whale/GP-Update–
I am a senior fellow in public health and journalism at the Center for Global Public Health at UC Berkeley, with an interest in research into the illness currently being called ME/CFS (or often CFS/ME).
Your organization recently disseminated a recruitment ad for FITNET-NHS, a clinical trial of online CBT for children. The recruitment ad promoted the intervention as â€œeffectiveâ€ for this illness, without equivocation. The recruitment ad also touted the intervention’s high rates of â€œrecovery,â€ based on purportedly â€œimpressiveâ€ results from an earlier Dutch study.
I posted a blog about this recruitment ad here:
Trial By Error: FITNET-NHS Recruitment Ad Promotes “Recovery”
The recruitment ad is problematic for a number of reasons. FITNET-NHS is an open-label trial with subjective outcomes, a study design likely to generate biased responses. The recruitment ad could have the effect of biasing the prospective study sample by priming participants to expect â€œrecoveryâ€ from a supposedly â€œeffectiveâ€ treatment. Promoting a treatment as “effective” and leading to “recovery” is an unacceptable recruitment strategy for a clinical trial of that treatment. *[the last sentence was corrected–see note at end of post]
Moreover, it is inaccurate to call the results from the Dutch study â€œimpressive.â€ The â€œrecoveryâ€ data were based on a post-hoc definition of â€œrecovery.â€ That is, the Dutch investigators made up the definition after they had seen their results. It was likely not a challenging task to construct a definition that yielded the desired rate of â€œrecoveryâ€â€”which is why post-hoc findings are accorded relatively little weight as scientific evidence.
To promote post-hoc findings as â€œimpressiveâ€ while omitting the salient detail that they are post-hoc findings is inappropriate and could be considered deceptive. Others can determine if it meets the definition of false advertising.
Your organizationâ€™s website makes no mention of your clinical trial recruitment services. (It is possible I have missed such a mention.) However, the website promotes your GP courses as “evidence-based.” That is not the adjective I would use to describe this recruitment ad.
Here are some of my questions:
*How did you come to send out this recruitment ad?
*Why didn’t anyone at your organization realize that this recruitment ad could bias prospective trial participants?
*How many GPs received the recruitment ad?
*What does your organization charge for disseminating such a recruitment ad?
*How did you vet the information in the recruitment ad?
*Who made the final determination that the claims were accurate?
*What is the arrangement between your organization and the sponsors of such a recruitment ad?
*Was this recruitment ad approved by the research ethics committee that is overseeing the study?
I would be happy to post your responses to these questions on Virology Blog: http://www.virology.ws
I have ccâ€™d officials of the UK Health Research Authority on this e-mail. The HRA oversees research ethics and could be interested in this recruitment ad, since it is likely to bias prospective participants even before treatment allocation.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley
*I originally wrote “acceptable” rather than “unacceptable” by mistake and corrected it shortly after posting. I also sent a follow-up letter to Red Whale/GP Update clarifying the point. However, I expect the original meaning was clear.