In Clinical Trials, Everything Starts with Dosing

By Rich Christie, MD PhD

Medication adherence, or whether patients take their medications reliably, is a fundamental indicator of patient engagement and a determining factor for whether or not a study will produce the necessary data to bring a new therapy to market. There are many reasons why patients might fail to take their medications, as people taking part in clinical research trials are juggling more responsibilities and stressors than most. 

AiCure recognized that if we could give these patients effective tools, we could help them to reliably meet their dosing responsibilities and, thereby, improve medication adherence and data quality across the board for any given trial. 

An Assistant in Patients’ Pocket

Using their own phone or one provided by the trial sponsor, patients can download the AiCure Patient Connect app from the iOS or Android app store. The features in the app can be configured specifically to any clinical research plan by sponsors and trial site staff. Depending on the therapy being studied, patient medication regimens can range widely in terms of complexity. Many trial patients have medication plans that ask them to take multiple doses over the course of days and weeks, sometimes in different amounts, sometimes with food or on an empty stomach – there can be a lot of details to keep track of. With the smartphone app, patients can receive regular reminders for when it’s time to dose. They also have access to easy-to-follow guidance on dosing, including short videos. Patients are instructed to record each dose taken using the smart device’s video recording features. This provides two-way peace of mind – the site team receives immediate dose confirmation or alerts if problems with dosing are identified. Patients can rest assured that if there is any issue, their site clinician will reach out right through their phone. The app also gives them quick and easy access to site team support should they have questions or concerns about their medications.

The Art and Science of Making It “Easy”

Good medication adherence enables the production of a wealth of study data not limited to safety and efficacy endpoints. Over the course of the study, adherence performance can help identify issues with specific sites or types of patients. This helps in future study planning, protocol design and site management strategies. 

In order to accomplish this level of data discovery, the technology must be easy for all users – including patients who may not be tech-savvy. AiCure focuses on a few key factors with the Patient Connect platform:

  • Global accessibility – To be truly inclusive and intuitive, the application needs to reflect any and all users. This means it must work in all countries and languages.
  • Regulatory compliance – Global accessibility also means compliance with the varied landscape of regulatory guidelines across the world. Different regulators and Institutional Review Boards mandate different things and, with studies including sites that span multiple countries at a time, universal compliance is key.
  • Connectivity – Medication adherence is a great marker for patient engagement. By having the app on their smart device, patients get easy-to-access channels for communication with the site team. Through this, they feel supported and empowered to tackle their study responsibilities remotely with confidence.

Patient Connect is about a great deal more than dosing reminders. Years of research, engineering and design went into the creation of the solution which utilizes advanced artificial intelligence to meet the patient engagement and monitoring needs of any clinical trial protocol. In order to truly optimize dosing, patients and sites need solutions that balance deep scientific rigor with ease of use. When used for dosing support, this results in improved adherence and better data. In a future blog, we’ll discuss how predictive analytics using these data can help sponsors to select higher-performing patient pools, leading to more efficient trials. For more information about AiCure Patient Connect, visit aicure.com.