We develop run clinical trials with different devices including our own prototypes and many of our clients seem lost with the number of things that need to be planned. Eventually, we help them through the various phases and only now have some of them begun to get data from their studies and analyze the data. These data sets will then be reviewed by a regulatory body and eventually utilized. Otsuka Pharmaceuticals is ahead of the game. They have a drug device combination that they have collected clinical data from, approved by FDA and are in the market.
At the wearable meeting, Dr Corey Fowler of Otsuka Pharmaceuticals discussed a different problem. The problem is what do you do after your device and drug combination is approved. First, some context. Otsuka is probably a first company to have approved a drug and wearable device rigorously testing and approved. It is ABILIFY MYCITE (aripriprazole tablets with sensor) and has a sensor in each tablet. The system consists of the ABILIFY MYCITE + a wearable sensor patch on the stomach area + an app. This system records when you consume a tablet and can communicate to the patient, their family and/or their healthcare provider. In addition, the system can record activity and other measures of mobility. The interesting thing about this process was that these drug and device combinations were both approved previously by the regulators but the company still had to do clinical trials to prove that the drug-device combination worked.The device was a Proteus Discover and the drug was Abilify. The next steps are what are interesting:
How do you implement this is practice?
Now that you have an approved system, how do you implement this? Will the patients like the reporting of the data. Obviously, the data is collected and so are there consequences for the patient? Given a choice between a “simple” pill and this combination pill what will the patients choose? Is there a benefit. The benefit to all parties exist but it does require change of behavior and the recognition that the pill consumption is being monitored. In neurological or psychological disorders this might be a very important factor.
What training is required
Putting a patch and executing an app are easy but if the patients are under stress – does it change how they behave with the newer technology? Who is responsible for the training – company or pharmacy?
Identification of the patient
Who is the target audience for this technology?
For example, if a patient has pain that is being relieved by a pill – do you necessarily need to monitor – probably not. However, if the patient is prone to forgetfulness or does not want to comply due to the disorder then this would be an extremely important step.
Physician responsibility
What are the physician supposed to do with the data. Lets say they identify that the patient is not taking it regularly. Do they notify the patient, payer or the company ? Or all of them? Will the physician get compensated for the daily monitoring or even monthly monitoring?
Payers
Often technologies are also driven by financial rewards. So if a payer is compensating the company for the newer technology what is in it for them? Will this show benefit for patients health and ultimately costs?
These are just some of the questions that arise from the use of technology. The technology to monitor pill consumption consistently with no toxicity and total reliability is great and it will be great to see it being used by a wide variety of population. Ultimately, like all new technology, it will a defined group of people who stand to gain from the use of this technology and will be the primary users whereas others might use it for a first few times for the novelty and then go back to other conventional pills.