Tuesday, June 19, 2012

Pfizer Shocker: Patient Recruitment is Hard

In what appears to be, oddly enough, an exclusive announcement to Pharmalot, Pfizer will be discontinuing its much-discussed “Trial in a box”—a clinical study run entirely from a patient’s home. Study drug and other supplies would be shipped directly to each patient, with consent, communication, and data collection happening entirely via the internet.

The trial piloted a number of innovations, including some novel and intriguing Patient Reported Outcome (PRO) tools.  Unfortunately, most of these will likely not have been given the benefit of a full test, as the trial was killed due to low patient enrollment.

The fact that a trial designed to enroll less than 300 patients couldn’t meet its enrollment goal is sobering enough, but in this case the pain is even greater due to the fact that the study was not limited to site databases and/or catchment areas.  In theory, anyone with overactive bladder in the entire United States was a potential participant. 

And yet, it didn’t work.  In a previous interview with Pharmalot, Pfizer’s Craig Lipset mentions a number of recruitment channels – he specifically cites Facebook, Google, Patients Like Me, and Inspire, along with other unspecified “online outreach” – that drove “thousands” of impressions and “many” registrations, but these did not amount to, apparently, even close to the required number of consented patients. 

Two major questions come to mind:

1.    How were patients “converted” into the study?  One of the more challenging aspects of patient recruitment is often getting research sites engaged in the process.  Many – perhaps most – patients are understandably on the fence about being in a trial, and the investigator and study coordinator play the single most critical role in helping each patient make their decision. You cannot simply replace their skill and experience with a website (or “multi-media informed consent module”). 

2.    Did they understand the patient funnel?  I am puzzled by the mention of “thousands of hits” to the website.  That may seem like a lot, if you’re not used to engaging patients online, but it’s actually not necessarily so. 
Jakob Nielsen's famous "Lurker Funnel"
seems worth mentioning here...
Despite some of the claims made by patient communities, it is perfectly reasonable to expect that less than 1% of visitors (even somewhat pre-qualified visitors) will end up consenting into the study.  If you’re going to rely on the internet as your sole means of recruitment, you should plan on needing closer to 100,000 visitors (and, critically: negotiate your spending accordingly). 

In the prior interview, Lipset says:
I think some of the staunch advocates for using online and social media for recruitment are still reticent to claim silver bullet status and not use conventional channels in parallel. Even the most aggressive and bullish social media advocates, generally, still acknowledge you’re going to do this in addition to, and not instead of more conventional channels.

This makes Pfizer’s exclusive reliance on these channels all the more puzzling.  If no one is advocating disintermediating the sites and using only social media, then why was this the strategy?

I am confident that someone will try again with this type of trial in the near future.  Hopefully, the Pfizer experience will spur them to invest in building a more rigorous recruitment strategy before they start.

[Update 6/20: Lipset weighed in via the comments section of the Pharmalot article above to clarify that other DTP aspects of the trial were tested and "worked VERY well".  I am not sure how to evaluate that clarification, given the fact that those aspects couldn't have been tested on a very large number of patients, but it is encouraging to hear that more positive experiences may have come out of the study.]

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