Understanding and monitoring meditation adherence during clinical trials is a problematic process. Researchers need to know that trial participants have administered the correct dosage at the appropriate times in order to fully document the impact of a particular medication. Elucid’s Pill Connect dispensing system, is one solution that is looking to provides CROs and pharma with the ability to show adherence across the whole trial, by country, by site even down to the individual patient number in real time.
Elucid’s system provides trial researchers with a dashboard that is automatically created by the dispensing of the pill/tablet through the intelligent Pill Connect cap which fits on any standard pill bottle. The patient receives a reminder on their phone when the pill or pills should be taken. The patient then touches the dispense button on the screen and the pill is ejected from the bottle and a signal is sent, via the phone, that the pill has been dispensed. If the patient does not respond to the alert a reminder text or even a call can be made to prompt them or find out why. The patient does have the opportunity to respond to the alert by tapping on the screen that they don’t feel well or that the pills are upsetting them.
All of this information is collected in real time and the dashboard can be customised to show what ever data is requested by the CRO, or pharma.
Stuart Young CEO of Panthera site management organisation commented: “Confident tracking and adherence to treatment needs this type of improvement to help ensure that the power of a study is not compromised. Investigators will really like this technology and it is simple to use and understand. We need more technology in research like this which is focused on the patient.”
Unfortunately patients who do not adhere to the agreed regime have been known to mislead the trial monitors which can really effect the results of the trial. Another benefit of the Pill Connect system is that it prevents double dosing – a real problem with some older patients. Once a pill is dispensed the cap locks until the next dose is due.
CEO of Elucid James Burnstone commented: “We have had a lot of interest from some of the largest pharmas and CROs as the device is not only simple and inexpensive but also provides a great deal of information on the dispensing pattern. If for instance we note that Saturday morning is a problem because the patient is playing sport we can work with the patient to find a solution which fits in with the protocol.”
As well as providing a customised dashboard for the monitoring organisations the system also can show the patient in graphic form how they are doing and rate them compared to other people in the trial.
The Pill Connect system has been through a number of robustness trials which has shown a 100% reliability both in the cap dispensing and the phone reporting back the data. It is presently undergoing trials with several major pharma companies.