ePRO Expert Talks Shop

No more pregnant males. Sounds like the punch line of a joke but it’s actually one of the benefits of ePRO over paper. Others include no more missing data and data that’s time and date stamped. Together, these capabilities create a technology that can improve the way drugs are developed. That’s how Phil Lee sees it.

Lee is the Chief Executive Officer of PHT, where he’s been involved with ePRO over the past seven years—a time frame that’s witnessed a big change in attitude toward electronic means. “Seven or eight years ago [it was] very much a new technology and unfortunately some of the early studies weren’t successful and there were regulatory and implementation concerns around ePRO,” he says. “We just don’t have those types of concerns anymore.”

Although there’s still more ground to gain, for the most part skepticism has been replaced with acceptance, says Lee, which has come by way of better instruments, regulatory support (both FDA and EMA), and popular attitude. “If you think back to 2000, how many people had cell phones?” he asks. “I think the next generation and everyone has just become more comfortable with technology.”

Comfortable yes, but what does it take to do it right? Answers to that question were provided by Lee back in March at PHT’s 2010 PRO and ePRO Conference, where he listed the following as among his top CEO insights on successful ePRO trials:

• Focus on data’s life-cycle. It’s as straightforward as thinking through what data you want and not putting the cart before the horse by building the device before you know exactly what it needs to support.

• Share the value. NBC used to tout that “Knowing is half the battle,” but in ePRO’s case it appears to be even more. “Most sites that see the value have no trouble working with it,” says Lee, who stressed the importance of sites being very comfortable with the devices.

• Don’t rush to translate. The fact is multi-language trials require more time. Use it to get the English down first and approved before starting translation. Also, “have a team that does nothing but localization,” advises Lee.

Not on the list but mentioned was the need for compliance on the part of sponsors when it comes to device design. It can be a tricky area, but unnecessary customization must be avoided, which means sponsors can’t approach vendors with a “my way” attitude. Instead, let all players on the team do what they do best.

As for vendors, Lee would like to see an effort made to lower costs. He described the device rentals PHT offers as one way they’re taking the sting out of up-front hardware costs. Overall, however, he expects declining prices in the years ahead, driven by experience, new technology efficacies, and optimized processes.

Something else Lee expects that he describes as less frequent but critical, is better integration across eClinical platforms and vendors. “The idea of being fully integrated is several years off probably,” he says. “Right now you’ll see pockets of integration, but over time we’ll do more and more of it.”