Site-less, PI-less Trials?
Quincy Bioscience just may be on to something. The Madison, Wis.-based maker of the jellyfish-based supplement Prevagen has just launched a portal that allows most interactions with its study subjects to take place exclusively online.
The site is www.HOPETrials.com and it works like this: When potential subjects hear about one of Quincy‘s trials—through their doctor or an ad on the web—they go to the site, indicate their interest and fill out a lengthy pre-study questionnaire. If they’re deemed appropriate for the study, they are randomized, then the supplement (or a placebo) will arrive at their home by mail. When enrolled in the study, subjects log on at determined intervals to answer questions about their experiences with the supplement in scientifically-validated surveys.
Study data is created with no one ever having to leave their computers at home. “With no need for a principal investigator or a site,” said Mark Underwood, co-founder and president of six-year-old Quincy Bioscience, “doing trials this way cost a fraction of what a traditional trial costs.”
Quincy, which just launched the portal, has conducted one study the traditional way (looking at whether the jellyfish protein apoaequorin helps improve memory) and two (another memory study and one on apoaequorin’s affect on sleep) using a pilot version of HOPETrials’ technology.
Each of the two online studies involved about 50 patients.
Now, the biotech firm is beginning recruitment for a trial that will look at whether apoaequorin changes symptoms of multiple sclerosis. They will conduct the entire study through HOPETrials.com. Underwood said he’s hoping for about 200 patients by July.
He acknowledged, of course, that conducting trials in this way wouldn’t be appropriate for studies where the subjects need to be under a doctor’s supervision, or where blood draws or other such tests are needed. But for gathering preliminary data on new indications for a product that’s already in the market and thus already safety-tested, he said it’s quite useful. Underwood said many times he’ll hear anecdotes about a new symptom or ailment that apoaequorin seems to remedy. Instead of launching big, multi-center trials to investigate each, these small, conducted-online trials can help the company gather data to see if there’s anything there. Underwood said it’s his hope that pharma companies, upon seeing robust preliminary data, will license apoaequorin and run full-scale trials on it for various specific ailments.
Underwood said he thinks that if other pharma, biotech and supplement companies considered this approach to trials, more products could get a crack at hitting the market. “This allows compounds to be looked at when otherwise they might have been overlooked because of the expense,” Underwood said. “It gives us a better chance to look at things that don’t have a big-pharma budget behind them but might be just as effective.”