The Coming of the MOOCT?

Big online studies, in search of millions of participants.

Back in September, I enrolled in the Heath eHeart Study - an entirely online research study tracking cardiac health. (Think Framingham Heart, cast wider and shallower - less intensive follow-up, but spread out to the entire country.)

[In the spirit of full disclosure, I should note that I haven’t completed any follow-up activities on the Heath eHeart website yet. Yes, I am officially part of the research adherence problem…]

Yesterday, I learned of the Quantified Diet Project, an entirely online/mobile app-supported randomized trial of 10 different weight loss regimens. The intervention is short - only 4 weeks - but that’s probably substantially longer than most New Year diets manage to last, and should be just long enough to detect some early differences among the approaches.

I have been excited about the potential for online medical research for quite some time. For me, the real beginning was when PatientsLikeMe published the results of their online lithium for ALS research study - as I wrote at the time, I have never been so enthused about a negative trial before or since.

That was two and a half years ago, and there hasn't been a ton of activity since then outside of PatientsLikeMe (who have expanded and formalized their activities in the Open Research Exchange). So I’m eager to hear how these two new studies go. There are some interesting similarities and differences:

• Both are university/private collaborations, and both (perhaps unsurprisingly) are rooted in California: Heath eHeart is jointly run by UCSF and the American Heart Association, while Quantified Diet is run by app developer Lift with scientific support from a (unidentified?) team at Berkeley.
• Both are pushing for a million or more participants, dwarfing even very large traditional studies by orders of magnitude.
• Health eHeart is entirely observational, and researchers will have the ability to request its data to test their own hypotheses, whereas Quantified Diet is a controlled, randomized trial.

Data entry screen on Health eHeart

I really like the user interface for Heath eHeart - it’s extremely simple, with a logical flow to the sections. It clearly appears to be designed for older participants, and the extensive data intake is subdivided into a large number of subsections, each of which can typically be completed in 2-4 minutes.

I have not enrolled into the Quantified Diet, but it appears to have a strong social media presence. You can follow the Twitter conversation through the #quantdiet hashtag. The semantic web and linked data guru Kerstin Forsberg has already posted about joining, and I hope to hear more from her and from clinical trial social media expert Rahlyn Gossen, who’s also joined.

To me, probably the most intriguing technical feature of the QuantDiet study is its “voluntary randomization” design. Participants can self-select into the diet of their choice, or can choose to be randomly assigned by the application. It will be interesting to see whether any differences emerge between the participants who chose a particular arm and those who were randomized into that arm - how much does a person’s preference matter?

In an earlier tweet I asked, “is this a MOOCT?” - short for Massive Open Online Clinical Trial. I don’t know if that’s the best name for it, and l’d love to hear other suggestions. By any other name, however, these are still great initiatives and I look forward to seeing them thrive in the coming years.

The implications for pharmaceutical and medical device companies is still unclear. Pfizer's jump into world of "virtual trials" was a major bust, and widely second-guessed. I believe there is definitely a role and a path forward here, and these big efforts may teach us a lot about how patients want to be engaged online.