Caroline Criado-Perez on why learning recent failings in online clinical trials could hold the keys to successful future attempts.
Remember school? Good. Now even more exact: remember history lessons? Right. So you’ll remember the fun of ‘sources’. There was always that rogue one the teacher threw in, just to remind you that no source, no matter how hopelessly biased, should ever be discounted, because it always tells you something about the context in which it was created. So a man writing about women’s brains in the Victorian era: not very helpful for the scientific study of brains, but very helpful for the historical study of male attitudes to women. It’s all about what questions we want answered.
What’s this got to do with pharma? Well, a lot actually. Last week Pfizer’s first foray (can’t resist alliteration) into social media recruitment for clinical trials met its demise. Perhaps predictably there’s been a certain amount of Schadenfreude doing the rounds, with some commentators gleefully seeing this as the incontrovertible evidence they’ve been waiting for: digital doesn’t deliver.
But of course, you only come up with that answer if you’re only asking, ‘did this clinical trial work?’ This is the wrong question to be asking. Rather than seeing this as a failure on Pfizer’s part, the industry should be acting like the good students we all of course were, and asking, ‘what can we learn from this?’ And the answer is, ‘plenty’.
There has been some suggestion that Pfizer were trying "too much, too fast". There may well be something in this: Pfizer’s trial combined a number of ‘modules’, including, “online recruitment, screening, and consent; at-home study drug delivery; mobile- and web-based tools for all data reporting; online identity verification and a centralised investigator site”, according to head of clinical innovation at Pfizer, Craig Lipset. That’s a lot of new variables to be trialling all at the same time.
The other possible problem was the drug itself that they were testing: Detrol. There are already a whole host of drugs for overactive bladders, and as a result, not as much incentive for patients to get involved with a trial. When it comes to online recruitment, the disease that the trial will benefit is crucial. While Pfizer was the first entirely online clinical trial, there have been others which successfully used social media to recruit. The key thing they nearly all had in common was that they targeted ‘a rare or potentially life-threatening disease and have an organized and demographically favorable patient population.’ And by ‘demographically favourable’, we can understand ‘patients who are knowledgeable about clinical trials’ – another hurdle which Lipset identified.
But although there are issues with the trial itself, its failure can’t be laid entirely at Pfizer’s feet. As Lipset himself says, “it’s still a new way for patients to engage and there’s a healthy amount of trepidation from patients about participating.” The internet is not a safe place. We are repeatedly told this. And now we are expected to just hand over our medical details? These are understandable concerns, and the pharma industry needs to work harder at educating the public on exactly what a clinical trial will entail. They need to feel protected, that they are involved with a company they can trust.
In this context, the pharma industry is sometimes its own worst enemy, as illustrated by the recent decision by Merck to advertise Claritin using characters from Madagascar 3. Merck can claim that they are advertising to parents as much as they like – we all know that this doesn’t look good. The image of advertising drugs to children as if they were sweets, whether true or not, is part of the reason that, despite the fact that the pharma industry is in the business of saving lives, it has such a problematic reputation. And this reputation is hardly going to help when you’re trying to engage with patients online, an arena already fraught with pharmaceutical dangers.
So this is a job for the industry as a whole. Pharma needs to earn the trust of patients before it can expect the public to enter into online trials with enthusiasm. Pfizer in fact seems to be on the right track with its newly launched website on ageing, GetOld.com. One commentator wrote that the project ‘is an unusual one for a drug maker to sponsor, as it does not promote or link to any products made by Pfizer.’ But that is just the type of blinkered thinking represented by those who refuse to see any positives in the Pfizer online trial. No, there may not be an immediate sale for Pfizer as a result of this site, but Pfizer, and the drug industry as a whole, can only benefit from getting more real world evidence from patients. The more we know about patients, the more we know what patients want, the more we can work to deliver that for them.
Just so with Pfizer’s trial. No it perhaps didn’t ‘work’ in the sense of acting as a successful trial of Detrol. But as a trial of what the pharma industry needs to do to get patients engaged online, I consider it a success. And that is an answer that we can all see the benefit of.
30% of pharma executives expect business as usual, as they admit to expecting blockbuster-type...
Lucy Brake speaks to Mike Rea, CEO of IDEA Pharma, about how he believes real world evidence...
Dr Jean-Michel Cosséry, the new UK managing director and vice president for its Northern Europe hub...