December 9, 2019 | In May 2019, the Digital Medicine Society (DiMe) launched as the first professional organization for individuals from all disciplinary backgrounds working to advance the field of digital medicine. “There wasn't a single professional home for all of the experts we believe need to be at the table to advance the field,” explains Jennifer Goldsack, the new group’s executive director.

The group is already hard at work interacting with regulators, sharing a Library of Digital Endpoints, and more.

On behalf of Clinical Research News, Marina Filshtinsky recently spoke to Goldsack about the challenges ahead for digital medicine, the opportunities, and how patients are responding.

Editor’s Note: Marina Filshtinsky, Conference Director at Cambridge Healthtech Institute, is planning a conference dedicated to Sensors, Wearables and Digital Biomarkers in Clinical Trials at the upcoming SCOPE Summit in Orlando, February 18-21. Goldsack will be speaking on the program; their conversation has been edited for length and clarity. 

What are your goals for the Digital Medicine Society? What fits within your mandate?

When we think about digital medicine, we are specifically talking about those high-quality hardware and software tools that are used to either measure or intervene in health. They are different from digital health tools—not better, not worse—requiring a much higher evidentiary standard before they are used to support healthcare or biomedical, behavioral, or population health research. Digital therapeutics—those digital medicine tools where the software itself is the intervention—are a subset of digital medicine and also fit or mandate..

Our aim at the Digital Medicine Society is to advance the use of digital medicine tools to optimize human health. And we do that in three ways:

1. Through evidence and knowledge generation,
2. By education and communication, and
3. By community building.

Do we have data yet about the real uptake of digital technologies in clinical trials, or we are still gathering that?

I'm really proud to share that in November of 2019 we launched a crowdsourced Library of Digital Endpoints, so I can give you some data. Currently in that library we have 39 unique digital endpoints being used in interventional trials of new medical products. And I think that's a really encouraging number because these aren't pilot studies, these aren't proof-of-concepts, these are interventional trials. I was really, really encouraged to see that number. That library of endpoints available on our website.

That’s impressive! Digital endpoints, as any other endpoints, need to be validated. Are you involved in that work as well?

Yes. So this is an important question to our community at DiMe. We had a working group that kicked-off immediately after our launch with 16 multidisciplinary experts working on this topic. And we proposed an evaluation framework—verification, analytical validation, and clinical validation—of digital measures for use in clinical trials. And that's currently waiting in the wings at NPJ Digital Medicine so there will be a DiMe publication forthcoming in 2020 on that exact topic. In fact, took the framework developed by the working group and used it in a public comment to FDA when they put out a public docket earlier this year. So, yes, this is a topic that we are laser focused on.

Are you in direct contact with FDA or is it just comments at public hearings and things like that?

We actively participate in public comments and I'm actually going to a public meeting on Friday. There was another meeting about medical device cybersecurity that we attended earlier this summer. We are active participants in all the ways available to our whole industry, but we are also very, very lucky to have both FDA and EMA representation on our Strategic Advisory Board, on our Scientific Leadership Board and on our Research Committee.

What are the bottlenecks and main challenges in implementation and adoption of digital technologies in clinical trials?

I mentioned before that we have already been working very hard on the evidentiary framework for evaluating whether these digital measures are fit for purpose. So, we've looked at the verification, analytical validation and clinical validation process for sensor-based measures. We started there because our members tell us that is the biggest challenge; the biggest cause of the bottleneck. But it's not the only cause.

There are other considerations, too. The way that we deploy the technology: things like utility and usability, getting sites on board, perhaps moving to a more hybrid design, thinking about how to handle these new flows of data, thinking about privacy and security. Those are all things that I think the industry is nervous about. Many of them I believe can be addressed. I don't want to dismiss them, but I think that we are much closer to solutions when we take a multidisciplinary look, and we draw from the expertise of our colleagues who have a whole background in the privacy and ethics around digital tools, for example.

Digital is new in our industry; it is old hat in others. There are lessons that can be learned from other fields and rapidly adopted into ours. So, our goal at the Digital Medicine Society is to look across disciplines, to look across industries and to synthesize that knowledge and to make it available as quickly as possible.

To summarize, I think that understanding how to evaluate a measure is the biggest problem. That's why we tackled it first. But there are other issues too that we will continue to work on as a society, and frankly that's the reason we exist.

To what standard should we be holding our digital tools?

I think that the whole clinical trials industry is being challenged on a number of levels right now. The pace of development, the cost of development is unsustainable, and we need to be open minded about taking alternative approaches. I also think we need to be realistic. Digital tools are not going to solve all of our problems. However, it is important that we don't get in our own way as we work to introduce these tools. Right now, we see many people holding them to a higher level of scrutiny than we do some of our current measures or our current approaches. Many of these existing approaches are far from optimized.

I'm not saying we should introduce new substandard tools, but I also think that we need to not hold these new tools that offer huge potential to a higher level than we do every single other element of our industry.

How do you think patient's roles and patient's perspectives on clinical trials will change with adoption and wide use of sensors in clinical trials and with the hybrid trials that you mentioned?

Patients have become accustomed to the use of digital tools in all other aspects of their life. Our colleagues at the Clinical Trials Transformation Initiative did a huge patient survey a year or two ago that said nearly 80% of patients would be keen to participate in a trial that had digital elements. I think that that finding is very positive. I think that patients through the use of commercial wearables and their smartphones, are increasingly comfortable with digital technology.

However, at the same time there have also been very high-profile stories of how some entities have been disrespectful of patient data. I think that is going to continue to give patients pause, and it is something that we must work incredibly hard on as an industry to make sure that digital medicine tools never make front page news for the wrong reasons.

With these digital datasets, with the use of digital tools out in the wild, with the ability to synthesize huge amounts of information on individuals about their health very quickly, we need to take individuals’ privacy and the security of their health information seriously. We need to make privacy and security a priority in order to capitalize on all of the benefits that digital tools offer without risk of harm.