invivodata is one of a select number of firms—along with Arrowhead, CRF, PHT,  and Symfo—specializing in handheld electronic diaries to record patient experiences in clinical trials.

At the 2007 annual Drug Information Association (DIA) meeting, ClinPage chatted with invivodata founders Saul Shiffman and Jean Paty. Shiffman’s additional titles include chief science officer; Paty is senior VP, scientific, quality and regulatory affairs. They started making patient diaries twenty years ago; the company was incorporated in 1999. Here they discuss the company’s philosophy, its approach to interactions with the FDA, and the general acceptance of electronic patient reported outcomes (ePRO).

At the time the company started, Shiffman was a University of Pittsburgh professor of psychology. Paty was one of Shiffman’s graduate students. Ten years ago, when the company discovered the embyronic Palm platform, invivodata rewrote its software, jettisoning an earlier investment in the Psion handheld device. They also enlisted a prominent member of the Palm developer community, cofounder Doug Engfer, who serves as president and CEO. Today invivodata has 100 employees, 20 of them in the U.K.

ClinPage: In the early days, to assess the computer skills of prospective study participants, you asked them if they could program a videocassette recorder (VCR). Why? To predict if they could handle a patient diary?
Shiffman: Even people who told us they could not program their VCR could do this. A lot of our training was hands on.

ClinPage:  Jean, you were the first individual to use one of Prof. Shiffman’s devices. Did you do everything you were supposed to do?
Paty: He’s got a printout of my data. He goes, ‘you didn’t use it on Monday and Tuesday!’ I was 100 percent compliant in the next round.

ClinPage:  Is it nice to see these devices gaining more acceptance across the industry?
Shiffman: The data and experience are what won the battle. It is very gratifying to see.

ClinPage: What were some of the highlights?
Shiffman: We and others have repeatedly shown we can do this. Patients will do their part. You will get data. image The [British Medical Journal] paper we published in 2002—that ended up having a very big influence. It forced people to confront the shortcomings of paper diaries and validate the strengths of electronic diaries. That’s been one of the turning points.

ClinPage: You started out asking patients to make one entry in the device per day. Isn’t that an imposition?
Shiffman: Lo and behold, people do it with extraordinary compliance. [In some recent trials] we are asking for 4 or 6 or more assessments per day.

ClinPage: Any surprises?
Paty: We have not found a population or a country or a disease condition where this is clearly, outright prohibitive. I was worried when we first went into eastern Europe. I was worried when we went into Japan. The performance of the Japanese patients has been amazing. I’m regularly having conversations with deep therapeutic experts. They are incredibly knowledgeable medically. Consistently, though, they underestimate what patients will do.

ClinPage: How important is the technology?
Paty: Saul and I are not technologists. We are psychologists. We are scientists. This is about how do we get the most accurate information to evaluate the efficacy and safety of drugs. That’s the vision. It so happens personal digital assistants (PDAs) are a nice mechanism.

ClinPage: How do you see your company’s relationship with the FDA?
Shiffman: A lot of our interaction with the FDA has been around science. They were very interested in that BMJ paper. The interaction is really a scientific collaboration. We don’t see it as a relationship we would try to milk for special favors or push our solution. Some of our clients experience FDA as a scary, dangerous monster. We see FDA as a group of reasonable people trying to accomplish a reasonable purpose—a purpose with which we agree. FDA, institutionally and individually, has been very open to have a dialogue. They are trying to do the best science. That’s a different realization than ‘what do I need to do not to get devoured?’

ClinPage: Before or after compounds are approved, can electronic diaries play a role in detecting safety signals?
Paty: We have seen diaries in a safety context. image ePRO is very sensitive at detecting signals. There are some pre-approval trials where safety is the key endpoint. But an adverse event is really a medical decision. We need to defer to health care practicioners. What we see the diaries doing is sending a signal that there is something to evaluate.

ClinPage: Congratulations and thank you for your time.