From The Editor | May 6, 2014

In Search Of A Few Good mHealth Heroes

By Ed Miseta, Chief Editor, Clinical Leader

Miseta

The potential for mHealth to transform the world of clinical trials is unlimited. New devices and technologies are making trials easier and less intrusive for patients while creating opportunities for clinics to simplify the process, see more patients, and substantially reduce costs.

To make this happen, companies will need to embrace and adopt new solutions and blaze a path forward for other pharma companies and CROs to follow. However, while consumers seem ready and willing to jump on every new technology that comes along, pharma can tend to be much more conservative.

That being said, where are we in the technology adoption process, and what companies will be the heroes that make dramatic progress, get their results published, and lead the rest of the industry into the future?

“Right now I think we are still in the early adoption phase of using mobile technologies in trials,” says Glen de Vries, president of Medidata Solutions. “It generally takes time for the adoption of new technologies to become mainstream, especially in the field of life sciences. Still, the fact that we are in the early adoption phase doesn’t mean companies shouldn’t be paying attention to it. Companies should be taking certain actions right now that will ensure their success in mobile health in 2015 and beyond.”

Companies climbing onboard and making the right moves today will find themselves in a good position to take advantage of all the benefits that will come about in the next few years. In fact, de Vries believes the most successful life science companies in 2017 will be the ones that were the early adopters of mHealth.

Early Adopters Will Lead The Way

Glen de Vries, president, Medidata Solutions

Unfortunately, it is hard to identify who exactly the early adopters are today. There does not seem to be a clear trend that points towards the sponsors, or large versus small CROs. That being said, there are definitely early adoption opportunities out there upon which companies can execute. Although de Vries is personally aware of several, he is not able to speak publicly about the specific clients or the actions they are taking. One clear pattern is companies making use of instrumentation that is easy to deploy and has connections to various therapeutic areas.    

Areas where de Vries sees a great deal of potential is with patients suffering from Alzheimers and Parkinsons. He believes there are applications coming online that will examine how patients type and how their hands move simply by analyzing how they use their smart phones. “I think there are very novel prototypes available and there is already early adopter activity,” he says.  “But I don’t think we’re going to see that technology in clinical trials as quickly as we’re going to see, for example, activity monitoring where we can take someone’s bio stats or data. Those devices are so prevalent and affordable that deploying them shouldn’t be too much of a challenge. There are still a lot of decisions to be made regarding which devices will be used in clinical trials. Not all activity monitoring devices will be accurate enough to use in clinical trials.”

Perhaps the more interesting takeaway from the early adopters will be the way in which all of this data will be used to achieve the key endpoints of a study. Regarding the data, de Vries expects to see a bi-modal distribution. Some clinics will see a huge opportunity to use directly instrumented patients as a way to support key endpoints they couldn’t use before. Doing so will give them a much better indication of the effectiveness of their drugs or devices.

Other clinicians will opt to replace something they are currently doing in the clinic with the collection of data at home, thereby lowering the cost of the study.

While some in the industry will be early adopters, others will not climb onboard until positive results are achieved and are proven to increase efficiency or cut costs. In that regard, de Vries sees some positive signs in the industry. “I think we are seeing a lot of Big Pharma firms really empowering their heads of innovation,” he says. “Many are now reporting up to a chief scientist or someone who is one level down from the CEO. We are not going to see mobile technology progress in all of them, but I think we will see it in many of them.”

Reduce Cost With Personal Devices

Few would argue that for mHealth to be both efficient and cost effective, the adoption strategy will have to involve patients using their own devices. Certainly the success of Medidata is one of the best proof points that that this strategy is economically the right one to pursue. It is now a market leader in developing mobile technologies to connect doctors, nurses, labs, sponsors, and CROs, built on the premise of bring-your-own-device.

“If you look at the technology world of the consumer, I think the most natural thing to do right now is to follow the strategy that other industries are using,” says de Vries. “The great consumer technology companies right now, such as Facebook, Google, and Netflix are all using the same bring-your-own-device strategy. Nobody is doing anything interesting with the internet. Whether its commerce or social media, everything is being provided in a device format.”  

One issue that could cause delays in the adoption process is the time it might take for device manufacturers to make the devices user friendly for the life sciences and develop standards to put in place. While this may not become an issue this year or next, it is something that may need to be dealt with by the end of the decade.

Finally, there will always be some amount of fear that accompanies the adoption of a new technology. Employees in any industry can be reluctant to change, but nowhere is that truer than in pharma. What we need right now is for early adopters to take the lead and demonstrate for everyone the potential mHealth holds to transform clinical trials.

“We need a couple of mHealth heroes,” says de Vries. “We need a couple of companies to make some really great progress in this area, and get their research into the New England Journal of Medicine. It will be a company that not only discovered something interesting, but found it in an interesting way. Shame on us as an industry if we can’t succeed in getting this story into a journal. That is something we really need to work on to drive this adoption in the future.”