One indication that the mobile health app market is maturing is the number of discussions on how to make apps that can stand up to scientific scrutiny. One of the finalists from Sanofi’s innovation challenge last year is applying this scientific scrutiny to developing a new generation of cognitive tools that could be used to create baselines for personal health and make clinical trials for Alzheimer’s disease and other cognitive degeneration conditions more meaningful and affordable.
The 21st Century BrainTrust includes a coalition of nonprofit groups — the American Health Assistance Foundation, Cleveland Clinic’s Lou Ruvo Center for Brain Health and the philanthropic Geoffrey Beene Gives Back Alzheimer’s Initiative. Clarksburg, Maryland-based AHAF was set up to get rid of age-related degenerative diseases through research seeking causes, prevention, treatment and cures, and promoting behavior to combat cognitive degeneration.
Guy Eakin, the vice president for scientific affairs for AHAF, told MedCity News in a phone interview that vetting mobile health technology with scientific criteria is necessary to gain the medical community’s support for these tools. The organization is laying down the groundwork with an eye to the baby boomer generation entering retirement age and the anticipated need to have effective ways for measuring cognitive function before segments of the population begin to show signs of senility. If there’s an agreed upon approach to tracking one’s cognitive health over time, then you could see a downward progression and physicians would have something that is data driven, as opposed to relying only on a spouse’s or family member’s observations.
A long-term clinical trial for Alzheimer’s disease treatment spanning years and surveying tens of thousands of people would be very costly because of the length of time it takes for the disease to progress. Mobile health tools to measure cognitive health would be invaluable to making these trials more affordable in the future. “We’re taking a long view of patient engagement,” said Eakin.
Eakin said the group isn’t interested in developing apps itself, but wants to incentivize mobile app developers in the cognitive health arena. “The focus is not on any one technology, but to help the entire field of technology and I think that’s a relatively novel concept,” he said. Additionally, it’s critical for these apps to be easily used by consumers.
Asked to highlight companies that he considers have done a nice job in this area, Eakin pointed to Cogspace and Digital Artefacts, the company behind the BrainBaseline app to measure cognitive function.
Eakin said the group will be making significant inroads into developing the criteria in the first and second quarters of 2013, and then focus on developing clinical trials for apps in well-defined populations.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
One of the most frequently mentioned drawbacks (and biggest challenge) to submitting mobile health apps to the scientific scrutiny of a clinical trial is that the app is frequently outdated in the year it would take to do a proper clinical trial. It will be interesting to see if 21st Century BrainTrust partners can strike a balance between making a trial scientifically valid and within the sell by date of the apps.
