Eyeing up adherence: A recent partnership addresses the challenges in clinical trials
A recent partnership to address the challenge of monitoring adherence in ophthalmic clinical trials was formed between Aptar Pharma and Kali Care. Here, Sina Fateh, MD, founder and CEO of Kali Care and Sai Shankar, director, Business Development — Connected Devices, Aptar Pharma, discuss this alliance further.
Patient adherence to therapy is a long-standing issue across the full spectrum of the healthcare industry. According to the World Health Organisation a mere 50% of patients in developed countries with chronic disease are adherent to their therapeutic regimen.1 This lack in maintaining a prescribed therapeutic schedule leads to medicines being less effective than anticipated and a significant increase in financial burden on national healthcare systems.
One such area where adherence to a therapeutic regimen is vital is in a clinical trial. The expense of a trial means that should the patient population not follow the recommended schedule of treatment they will be deemed as unusable in the clinical write up. This in turn means that more patients will need to be sourced and the trial process started anew.
With soaring clinical trial costs and complexity, numerous industries are constantly seeking new approaches to improve efficiency and productivity, to get to commercialization sooner and for less cost.
Ophthalmology is not excluded from this and given the fact that we have a globally ageing population, most of whom will need some form of eye care (glaucoma, posterior segment, cataract recovery, for example), patient adherence at the clinical stage and thereafter is of utmost concern.
Challenge of adherence in ophthalmic clinical trials
To address the challenge of monitoring adherence in ophthalmic clinical trials Aptar Pharma entered into a partnership agreement with Kali Care,2 which is a technology based company based in Silicon Valley.
When using eye drops as a drug delivery method, there are many challenges to overcome in relation to patient adherence. Will the patient remember to use the drop at the correct time/on the correct day? Will they apply the drop correctly, ensuring enough of the therapeutic content is administered?
A way to more accurately collect patient adherence that is also done in a time effective way is obviously beneficial. To this end, Kali Care’s digital monitoring system has offered an innovative solution.
By replacing usage assumptions and self-reporting the monitoring system improves accuracy and time efficiency in clinical trials. The Kali Care system manages this through integrating smart sensors, data analytics and cloud services.
Helpful for eye care and beyond
This partnership addresses the megatrends in the pharmaceutical industry, which includes precision medicines, outcome based insurance payments and comparative effectiveness research. All require objective adherence data, targeted delivery and personalised messaging.
In the ophthalmology space specifically, any eye disease requiring an eye drop can benefit from the Kali smart system. Beyond eye care, this technology can also be applied to other drug delivery routes of administration such as topical dermal and nasal.
Through this partnership, it is hoped that Aptar’s regulatory expertise can help to move Kali Care forward through approval and compliance processes. Aptar’s ophthalmic device knowledge and ability to support complex projects in addition to Kali Care’s monitoring technology will be applied to packaging for clinical trials.
The first clinical trial incorporating Aptar Pharma’s drug delivery devices and Kali Care’s monitoring solution is anticipated within the second half of 2018.
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