Medidata Blog

Mining Clinicaltrials.gov for mHealth Data

Reading Time: 3 minutes

 

We already talked about the peaks and valleys of the hype cycle and what it means for mHealth. So where are mHealth tools right now on the road to widespread adoption by the clinical research community?

We were poking around ClinicalTrials.gov recently and thought it would be helpful to share some of what we found. (ClinicalTrials.gov is a repository of publicy and privately supported clinical trial information maintained by the National Library of Medicine.)

It’s not a perfect resource – not all clinical studies are added to the site and the search results can vary depending on your search terms – but it can still provide a helpful snapshot of clinical trials in the United States. We searched ClinicalTrials.gov for a string of words associated with mHealth that might appear in the trial description, outcomes, inclusion/exclusion criteria. We searched for words like “smartphone,” “wearable” and “Fitbit.”

From 2012 to now, we found only 41 studies in which industry sponsors included an mHealth component in the information they provided to the database. So what does that tell us?

Nearly half of the industry-sponsored studies with an mHealth component can be characterized as feasibility studies. The goal of many of these studies is to assess a device’s ability to effectively measure a metric. Wearable devices, apps, and other mHealth tools are flooding the market, and companies are clearly still trying to determine their applicability to clinical trials. At Medidata, we sponsored a clinical trial to assess the feasibility of an activity tracker for diabetes studies. The results of our study were overwhelmingly positive.

These feasibility studies signify the beginning stages of mHealth’s role in clinical development. It just takes one company to go first. As more of these tools are validated for use in drug approval applications, the more mHealth trials we will see.

The types of devices used in the industry-sponsored trials we found can be split into four main categories – smartphone apps, movement-tracking wearable devices, other wearable devices and data distribution tools, which includes tools like text messaging services and video links between doctors and patients. Non-movement wearable devices include defibrillators, ultrasounds, and heart monitors that can be worn by patients when they aren’t at a clinic.

Nearly 75 percent of the trials we found used mHealth tools for a primary or secondary endpoint. Further, more than 60 percent of trials with an mHealth-associated endpoint used a patient-reported outcome. This is helpful in thinking about how and why mHealth technology is being used.

Sponsors are beginning to bring the voice of patients directly into clinical trials with quantifiable measurements and systematic approaches. The FDA has let it be known that patient-centric drug development is a priority, and we are in the early stages of seeing this in action.

The mHealth trials we found reflect our current thinking on how mHealth tools are being used for specific therapeutic areas. Just in sheer numbers, cardiovascular, central nervous system and oncology represent the top three therapeutic areas for all clinical trials. While CNS and cardiovascular are well represented in the mHealth trials we found, oncology lags significantly.

mHealth Trials by Therapeutic Area

The focus of cancer drugs is to extend life. Any measures of quality of life are just now entering the discussion, and so mHealth and patient-reported outcomes currently play a small role in oncology drug development.

It should be noted that in total, we found 774 mHealth-related trials since 2012 — far more than the 41 industry-sponsored studies we’re discussing in this post. Most of these trials are academic or government-sponsored trials, which makes sense. As new technology becomes available, basic research often starts in academia with funding from government organizations like the National Institutes of Health.

Do these findings align with your current expectations for mHealth trials in the U.S.? I’m curious to hear your thoughts in the comments section below.

Mark Ediger is a clinical business analyst at Medidata.

Jacob Angevine