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On My Apple "Watch" List

By William Tobia posted 06-28-2015 11:52 AM

  

The new Apple wearable device is no longer on my "watch" list, and that's because it's now on my wrist!

After one week with the Apple Watch, I find myself ramping up my search for news articles discussing health tracking features, along with updates concerning the ResearchKit SDK and the apps already available.

And all of this information has got me thinking about where the Apple Watch will fit into the future of clinical research. But before we get to my vision, we need to start with where we are now.

All of the entities involved in healthcare are trying to reach the right balance between safety, effectiveness, efficiency, and cost. For the purposes of this blog, let's just concentrate on three of these entities (pharma, patients, FDA).

PHARMA – “Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development.” Therefore, anything that would save time and cost, would be welcomed by the pharma industry.

PATIENTS – When it comes to healthcare, in general, we can be a demanding bunch – we want new medicines now, to make us feel better now, and we only expect to pay a “reasonable” price for them. Again, expectations weighing heavily on time and cost.

FDA – And then we have the regulatory agency that feels time and cost pressure from both pharma and patients.

So, how can the Apple Watch positively impact the time and cost of clinical research – by using it to collect the bulk of the evidence as pharmacovigilance data, thereby shortening the clinical research data collection period. Now don’t get me wrong, the above three entities still expect that new medicines undergo development of a rigorous safety profile. However, I envision that once a “baseline” safety profile is developed, we will see the industry move to an earlier approval of these products, and collect substantial confirmatory pharmacovigilance data by using the health tracking features of the Apple Watch.

Are those features and apps currently available – no – but we are thinking about the “future” of clinical research, which will be facilitated by “future” features and apps.

So tell me what you think – is there reason to believe that this will be the future direction of clinical research? Will the pharma industry be willing to subsidize the Apple Watch, for pharmacovigilance data in return? Will patients be “compliant” with using these new wearables? Will the FDA embrace this as part of the risk-based monitoring (RBM) movement?

I will eagerly "watch" for your responses!

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07-02-2015 04:00 PM

I am cautiously optimistic about this trend. A few pros/cons from my personal perspective are summarized below.
Pros:
- greater reach for potential trial participants
- potential for increased compliance. Protocol-required data collection can be gathered automatically or reminders sent to the participant to visit the trial site. Participant may feel a greater sense of ownership and active involvement in the trial.
- shorter study timelines: recruitment, data collection, data cleaning
- I like the idea of the informed consent modules with a test at the end to ensure comprehension. I personally think this would be an asset to all trials.
Cons
- perhaps greater potential for data privacy breach
- study participant must have their device 'in-use' at the required times. For example, I got on the 'fitbit' trend. However, it's usually midway through a run that I realize that I forgot to put it on...
- commitment for the user to maintain the device throughout the course of the trial. What if their 3-year plan on their device is expired but the trial is still ongoing?
- validity of data: consent and any data collected. What assurance is there that it was actually performed by the participant?