Clinical trials fail when patients don’t take the study drug. Therefore, it is critical to understand how much medication patients are taking and when, since the quality of these data directly impact the efficacy and safety results of the trial. Many trials underestimate the study drug’s efficacy while overestimating its safety. Inaccurate medication adherence data also contribute to increasing trial costs, duration and risk of failure.
Until now, sponsors have relied on blister packs, which are routinely returned empty, or expensive blood and urine tests, which are performed intermittently and provide a snapshot of adherence. Other types of monitoring include patient self-reports, smart packaging and digital caps.
And yet, we are we still in the dark about patient behavior for the following reasons:
- Difficulty confirming ingestion outside the clinic
- Incomplete dosing histories
- Ineffective intervention based on poor data
- Insufficient patient education and follow-up
- Duplicate enrollment and malicious intent.
So how can we prevent these things from happening?
To know what patients are doing once they step out the clinic door, you must confirm actual ingestion. You need to verify a patient’s identity to make sure the registered study participant is the one taking the medication. And last, you need to be able to intervene with the patient in case of poor-quality data or dropout risk.
When determining adherence solutions, some practical operational issues also must be considered, including whether the medication manufacturing process needs to be changed, cost of the approach and speed of deployment.
Adam Hanina is CEO of AiCure, which has developed advanced facial recognition for smart phones and tablets to monitor the full sequence of medication administration. He has acted as a subject-matter expert on medication adherence technologies for the National Institutes of Health. He is a passionate advocate for the use of healthcare software as a population health tool and has more than 16 years of experience deploying healthcare technology strategies.
www.aicure.com