Q: What brought you into the clinical research industry?
A: I got into the clinical research industry in the ’90s when I started working at Genentech. At the time, I was in data management and spent pretty much my whole career at Genentech in data management. I ended up overseeing the data management group for their oncology center and working mostly on the Herceptin trials and the early trials for what is now Avastin.
Back in those days, everybody was doing clinical research on paper. We did all of the international Phase 3 trials for Herceptin on three-part no-carbon-required paper, mailing it around the world and then data entering everything. Although I loved Genentech and it has certainly launched my career, I wanted to develop a technology that was faster and more effective. I left Genentech in 1999 to co-found a company that makes electronic data capture systems for clinical trials, called Nextrials.
Q: What happened next?
A: I left Nextrials in 2008, after almost 10 years there, and I met Dr. Steve Cummings (Mytrus CEO and chairman) and got excited by his idea of building more of a consumer-focused clinical trial that would allow patients to participate from home. I joined an advisory board that Steve was putting together to sort of vet out this idea, and we ended up deciding to form Mytrus around that. I joined as a co-founder and as the vice president of product development and commercialization and I now serve as chief operating officer.
Q: Mytrus is hoping to validate a new kind of study model. If this kind of remote results monitoring works, what might the future look like for pharmaceutical companies and their trials?
A: We hope that it’s going to make a big difference. Our hypothesis that is staring to play out is that there are some kinds of trials – we estimate about 15 percent to 20 percent – conducted in the United States annually that can be done using this method. They do not require specialized equipment at a site. They do not require specialized training, and, if a patient is willing and able to correspond via the web and provide their own updates about what is happening to them during the study, then those trials are suitable to use this method. It really changes once you free your mind, as Steve likes to say, from the idea that you have to have a bricks-and-mortar site for trials.
You do not have to have as much monitoring because the patients are the direct source for data and you do not have data being transcribed from the patient to a chart and then from a chart to an electronic data capture system and then from an EDC system to an alpha system. All those data transcription events are the reason monitoring was effective — to make sure nothing got missed or skipped or inadvertently entered. So, you could get rid of a lot of that. You don’t have to go through the contracting and start-up and hierarchy approval with hundreds of clinics around the country.
Q: What are the technology requirements for participation?
A: If you do not have an Internet connection, you cannot do it. In fact, depending on the trial, there are some studies where it is really going to be critical to have an Internet connection in the home. There are other studies where it would be perfectly suitable to have a smart phone or an iPad or even a shared Internet connection in some sort of public place if the patient is comfortable using that and it is private enough that someone can enter their own data. Patients are much more apt these days to use the Internet for their own medical research and they are much more comfortable communicating with doctors over email or over the Internet.
Q: What are you looking forward to hearing about at the CHI mobile health event “Take this Pill and Tweet Me in the Morning?”
A: There is just a lot more focus on health 2.0 technologies these days and so we’re excited about being involved. It seems like the lineup of speakers are people on that leading edge of moving trials or studies or health in a new direction so it is a perfect kind of conference for us.
Hear more from Anthony Costello at “Take This Pill and Tweet Me in the Morning,” happening Aug. 4 at the Salk Institute in San Diego.
CHI-Advancing California biomedical research and innovation