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Comment by choxi | Hacker News Reader

> The amount of noise in human clinical data can defy belief if you haven’t seen it in person

I'm not surprised that patient compliance is a problem, but it still seems like an expensive burden to find patients physically near the clinical trials so they can come in to take the medication. It just seems like a logistical nightmare that software could help with.

Could you build an app that requires patients to record themselves taking their medication under whatever conditions they're supposed to? You might have to manually audit all of the recordings, but the number of people that still fail to comply might be offset but how many more patients you can include in the study. There might be a lot of other things you could verify remotely using wearable tech, e.g. heart rate now that Apple's EKG monitoring is FDA approved.

Great read, I'd like to see more "Chesterton's Fence" arguments for other highly regulated industries.

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"Could you build an app that requires patients to record themselves taking their medication under whatever conditions they're supposed to?"

Yes. I work for a company (Signant Health) which does clinical trial platform as a service (among other things) and our platform has this feature that the trials can have steps which require the users to video certain things.

And we are hiring https://signanthealth.com/careers/ :)

There are apps in use now that monitor drug use for psychiatric patients by trying to detect that a drug was ingested using a sensor inside the pill that can be detected with a patch placed on the abdomen. The patch is connected to the phone and reports back to doctors.

This itself had to be approved and has a number of ways it can be prone to errors and blow a trial by misreporting if it were used for one.

Generally, especially under the current circumstances for at-risk patients, there might be a push to do more electronic reporting for clinical trials. However, the requirement to have patients near a trial center isn't that bad, you don't have to be right next to it. But when patients drop out of trials it is very expensive to the company so reducing travel problems is important in addition to maintaining consistency.

> There are apps in use now that monitor drug use for psychiatric patients by trying to detect that a drug was ingested using a sensor inside the pill that can be detected with a patch placed on the abdomen. The patch is connected to the phone and reports back to doctors.

Do you have any more information about this please?

Yes, take a look at the following. It sends various data to a doctor and in addition patients can report their own data for monitoring purposes.

https://www.abilifymycite.com/

Excellent, thank you!

>> There are apps in use now that monitor drug use for psychiatric patients by trying to detect that a drug was ingested using a sensor inside the pill that can be detected with a patch placed on the abdomen

Wouldn't that be easily fooled by just pressing the pill against your abdomen for a while, and then throwing it away? Or sticking it with a piece of duct tape?

Seems like this solutions kind of assumes that all pshychiatric patients are stupid.

That particular way of gaming it won't work. The sensor inside the pill is a tiny logic circuit that transmits a signal throughout the patient's body. The current comes from basically building a battery out of the patient's stomach with the polar molecules in hydrochloric acid. The current contains some data and the worn patch detects the tiny sine wave.

It would be difficult to game this but it is still possible. The app itself could be broken for example.

I think the FDA approval for this device assumes the patient actually takes the medicine so no guarantees are made if the patient doesn't.

To tie this to my point, adding in electronic reporting and measuring opens up a number of possible ways of getting false data during a trial so I think it would be difficult to manage that. For example, in oncology trials, monitoring for adverse events and cancer progression might involve blood draws for analysis and maybe a monthly progression scan. These types of things are much easier controlled at a central location. Although not all trials are the same and electronic monitoring and reporting seems to have a lot of potential for drug usage and trials.

Many trials do NOT require patients to come in to take the medication, but there are of course some which are harder to take at home (whether intravenous or intrathecal or whatever).

But compliance is certainly hard to assess and so important. Your app thought reminds me of "Video Directly Observed Therapy" which is commonly used for things like tuberculosis medications (due to painful combo of lengthy duration of treatment, disproportionately affecting less well-off / well-educated people who are more challenged in compliance, and public health risk if inadequately treated).

Several companies have also worked on pills with an component that detects when it's been ingested and beams a signal to a (external) device, thus "confirming" ingestion.

Although of course, in a way, compliance is part and parcel of your drug's overall effectiveness. Not to dive into efficacy vs effectiveness and the larger considerations... but what if your drug "works" but nobody can be compliant? Of the top of my head, a few antibiotics are like, dosed 6 times a day, so I'd rather prescribe most patients a different one that's only taken twice a day, even if the 6 times a day antibiotic is technically "better" for their infection.

Good luck trying to get them to use an app if you can't trust them to take a medication.

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