Can EDC Be Innovative?

Innovate or die is not the crisis we face in the highly-regulated pharmaceutical industry. According to Keith Howells, Senior Vice President, Development for OmniComm Systems, and long-time industry technology expert, the challenge is to “innovate regardless.”   There are many roads to innovation, but for a technology that’s been around in clinical trials since the early 2000s-and only fully-adopted within the past three years-can electronic data capture (EDC) be considered innovative?

Keith Howells

  Howells told Applied Clinical Trials that there is a philosophical discussion: is EDC a commodity? To believe EDC is a commodity, one has to be assured that the technology offers nothing new. And if a service provider needs to create the value-add or revenue opportunities for EDC, then one business model is to build complementary products to the EDC. For example, offering additional features or solutions such as CTMS, safety, electronic patient reported outcomes, randomization, and supplies tracking.    “Our belief is that EDC is never going to be finished,” stated Howells. “If you sit on it and let it go out of date, then people aren’t going to want it because it’s missing the new features, or it was good enough 10 years ago but the user interface isn’t good enough now. So we are continually re-investing in EDC both in terms of usability and different sources of data.”   If EDC is never finished, then how will it evolve? Howells says, “I think it’s got a bright future. In a way it was cleverly named at the start as Electronic Data Capture rather than Entry. And Direct Data Entry is declining. In more and more cases, the source data is already electronic, so people ask why should I be typing it in again? The trend is whether I’m talking to an instrument right in the clinic, or whether I’m talking to a mobile health device, or extracting data from the EHR, I still have to capture the data. Therefore, in our mind, the EDC system is the only logical place where all these sources can come together and all these data can be validated for consistency.”     EDC’s role is the central hub where all the clinical data sources can live. OmniComm Systems, like many other companies, is looking at companies like Validic to ensure that its TrialMaster EDC system will integrate with digital health information, such as wearables and other devices. In another foray to broaden its EDC appeal, OmniComm is piloting an EHR API that pulls relevant data from the EHR into the EDC, such as the patient’s medical history. Another initiative is looking at RFD, request form data capture, where the EDC system puts up those relevant pages into the EHR when the patient is enrolled in a clinical trials.    With Howells experience working at both Medidata and Oracle, the technology expertise he brings to OmniComm is helping them grow in these and other areas. For example, Howells was the driver for writing RBM support into TrialMaster in 2012. And while it wasn’t until 2015 that their first client used the RBM features in a trial, the growth has been exponential since then. “It’s rewarding that we get very specific or complex requests for the RBM capabilities and we can do it. It’s taken the industry 3 to 4 years to adopt RBM, but they are using the features we wrote four years ago,” says Howell.    Howell continues, “If you fully automated TransCelerate’s methodology, it would be a $10 million development effort. To our minds, it’s much more pragmatic to have a general idea what you need, then look for the technology, and then adjust the processes to what the technology can do. And then you can automate, make it reproducible and then train people and then you have a good chance of a step change improvement in productivity.”   In the early days of EDC, Howell remembers the software bugs, workflow inefficiencies, computer down time, but everyone was just happy to have all the data not be on paper. Ten years later, industry expects everything to work and work flawlessly. “They want everything to work as well as Amazon. All of the data, tasks, and moving parts in a trial make people just too busy to have things go wrong. For us, that turns into an overriding focus on quality and innovation.”   Howells says that the pharmaceutical industry has slower adoption curves because the regulations are onerous, the cost of a mistake extremely high, and the patent protection that affords a company to count its revenues for many years, makes for a slow moving industry. The opportunity for better advantage through competitive technology is not as great as what a compound is. But says Howells, “You have to accept that and innovate regardless. If you have figured it out better than anyone else, then they will come and you will have those customers.”