GSK's Bold Move Into Uncharted mHealth Waters

By Ed Miseta, Chief Editor, Clinical Leader

While some sponsor companies continue to fret over the challenges of incorporating mobile and wearable technologies into clinical trials, GSK is one sponsor that has been boldly moving forward. GSK’s thinking and efforts in this area are certainly attributes that others should emulate.

I recently spoke with Rob DiCicco, VP of Clinical Innovation and Digital Platforms at GSK, to discuss what is driving adoption of these technologies, CRO expertise, regulatory concerns around mHealth, and more.  

Ed Miseta: I think it’s safe to say that mobile and wearable technologies will change how companies and patients view clinical trials. What is currently driving that change?

Rob DiCicco: It would be easy for me to say that necessity is the mother of invention. That is very cliché, but the reality is that the consumerization of healthcare will change the way we do clinical trials. Patients are accessing their healthcare in different ways, and will be able to manage how they share their healthcare information, their data. This is forcing sponsors to change the settings and tools we use to collect clinical trial data. When you think about it in those terms, it becomes very simple. Companies will adopt these technologies. It is not a matter of if, it is a matter of when.

Miseta: If you were doing a study that incorporated mHealth technologies and it’s also one you were going to outsource, would it be important that the CRO you chose has knowledge and experience in this area as well?

DiCicco: The CRO would absolutely need to understand these technologies. It would certainly need to have that knowledge to execute the trial. But I would also expect it to bring something to the table in terms of know-how, to help us make sure we get it right. Historically, GSK has been very progressive in terms of taking advantage of knowledge that exists inside and outside the company. We do not care where good ideas originate. We celebrate the fact other people may know better than we might know, and we get better by working together. I want CROs to be able to execute our plans, but I also want and expect our partners to bring their know-how and ideas to the table and to help us develop the best possible plan.

Miseta: One benefit of mHealth technologies is making trials easier for patients. But do you also give consideration to how you can grow your mHealth solutions into post-approval applications?

DiCicco: Fitness applications, whether they are for exercise or weight loss, result in improved outcomes for patients. There is now published data on wellness supporting that. We have also been able to prove that certain types of apps will also have positive benefits on health. I also believe a certain app or device, in addition to your pill or injection, will provide greater benefits than either one of those things alone.

However, to achieve the maximum benefits from these technologies, you need to start thinking about them early in development process. If you wait until after the product is on the market, achieving those synergies becomes much more difficult. It becomes much more difficult to introduce into your label. The studies you have to do will wind up being more complex, and you will have to spend more time validating that app before you can actually do the work that allows you to generate the data needed to change your label. With medical mobile apps, you need to have a quality program in place, similar to the quality program you need in place around the manufacture of your medicine.

Miseta: That’s a far different scenario than the type of apps millions of people download every day.

DiCicco: Exactly! These are not like the free apps that my kids download to play a game. Every week they want a new app. When a glitch appears, they say “this app stinks” and they delete it. We cannot do that with a medical mobile app that’s supposed to be part of the patient benefit. That’s why it is so essential for companies to have a quality program in place that is similar to the quality program you have around their manufacturing processes.  

I have heard people refer to this as the “pill-plus paradigm.” It is the medicine plus the app. In my opinion, that really needs to be considered earlier in the development process.

Miseta: Could the trial itself then be a trial for the app post-approval?

DiCicco: That’s a good question. I think that as long as you design it right and have conversations with the regulatory bodies, you could have a trial. A portion of the data will be a validation step and a portion will be the test step. I recently attended a conference on the future of clinical trials with neuroscientists and heard from a statistician from the Duke Clinical Research Institute. He discussed how data can be pooled in different ways to allow the validation of an input. But that’s only half the story. You also have to have quality control over that app. You have to know that no matter how many software updates are performed, the app is always going to do the same thing.

There needs to be a certain level of robustness. If an app crashes, it can have an impact on the patient’s health. If a patient is a type 1 diabetic and depends on that app to tell them their blood sugar levels and when they might need another injection, that app better work all the time.

Miseta: Do sponsors still have regulatory concerns around the use of mobile devices and apps?

DiCicco: I think the answer to that question is yes. It feels risky to try to go first. It is still a concern that we have to overcome at an industry level. There are imperfections in the way we work today. There are risks in the way we work today. The way we work today is we have patients to come in for a visit, and take a snapshot at that moment in time. We are very comfortable with that model because that is the way we have always done it, and we have submitted a number of drug applications based on that model. I think we are very uncomfortable with getting away from that at an industry level.

But we also need to start thinking differently about clinical trials. Those snapshots we take every month are not perfect. Adherence with study procedures (medication administration, assessments, diary cards etc) are rarely 100%. That’s a reality.

Right now, we live with those imperfections and we do the best we can and we have ways to deal with missing data. It will be no different when a battery dies and some of the data does not get transferred. Imperfections will exist, but with live data taken electronically over that entire month, we are provided with a lot of information that we otherwise would not have.

The thinking really needs to change. Continuous, live data may well be better than snapshots. Devices can make the trial more manageable for patients and keep then involved to the end. As an industry we need to stop worrying about battery life and start thinking about those critical factors.