Image showing a patient with medicine

Given everything else patients have going on in their lives, it can be an unsurmountable burden for people living with a?chronic illness, such as elderly cardiovascular patients, to comply consistently with self-administered medication protocols.

While most clinical trials spend millions of dollars or more on clinical systems to improve data management, very few provide any meaningful support for patients at home to help them stay active and compliant.

Why aren’t more companies using these cost-effective and easy-to-implement solutions? Let’s take a look at one that did.?

The Impact Of Poor Compliance

The importance of consistent medication adherence for studies with self-dosing requirements cannot be overstated. As has been reported in Applied Clinical Trials, poor compliance has an exponential impact on the number of patients needed to reach the same statistical outcome. Research shows 40% of patients become non-compliant at five months on study.1 This means an average Phase III trial will require an additional 460 patients at an estimated cost of $12 million.2 Costs will be even higher for certain programs such as lengthy cardiovascular studies and complex oncology trials.

Opportunities To Improve

Even an incremental improvement can make a significant difference in time and on the study budget. The phase 3 trial referenced above would yield $335,000 in cost savings for each 1% increase in adherence.

As the CASE STUDY on the next page shows, a technology-based dosing manager can help patients, even in the challenging elderly patient demographic, achieve compliance rates up to 98% at 18 months on study.

The Challenge

A leading pharmaceutical company sponsored a cardiology trial that required elderly patients to self-administer cardiometabolic medication in tablet form 2x/day in a chronic fashion over multiple years. Published data for average medication adherence in cardiometabolic disease is 56% over 12 months. Twice-daily dosing has even lower adherence.

The Solution

For this phase 3 trial the study team deployed a technology-based dosing mechanism. It helped improve medication adherence by using interactive SMS messages on patients’ personal phones. The dosing manager solution sent protocol-specific automated text messages that prompted patients to take their medication at the scheduled time.?

The system prompted patients twice daily with an SMS message that enabled them to quickly and easily confirm they had taken their dose–i.e., the patient would hit the number “1” to confirm they took their medicine on time. In addition to ensuring compliance, easily accessed dosing records mitigated the risk of patients over-medicating because they forgot they had already taken a dose.

This simple process removed burden for elderly patients who (counter-intuitively) typically have higher technology compliance than younger people, in part because? they have more spare time and stronger relationships with their care teams.

Sites received weekly compliance reports, which allowed them to identify patients who would benefit from additional support and follow-up.

Maintaining Patient Engagement

In addition to a dosing manager, technology solutions which kept patients engaged during this trial included:?

        • Digital concierge

        • Uber Health transportation

        • Virtual visits (due to COVID-19)
        • Consent

    Patients consistently demonstrated 2x/daily medication adherence at 70% and? above throughout the duration of the trial. Patients treated at several major academic research centers reached as high as 98% adherence at 18 months on study, with an overall average compliance rate of 86.5%. A few of the research centers along with their patient adherence percentages can be found.

    Lessons Learned

    Technology providers should evolve their technology and service delivery best practices to ensure continual improvement in patient compliance.?

    This trial faced unique challenges and presented lessons learned technology providers can incorporate into future clinical trials, including:?

          • Make site participation mandatory– Keeping it optional means fewer patients will receive benefit from a dosing manager.
          • Focus on supporting ex-US sites– While most eClinical technology is inherently global, some countries may have specific deliverability issues a technology provider can solve with a telecommunications partner should challenges arise. It is important to monitor compliance at ex-US sites to identify and resolve issues proactively.
          • Follow up with non-compliant sites– This ensures sites are reviewing reports and discussing the importance of consistent dosing with low-adhering patients. It is especially important for sites with significant staff and study coordinator turnover.

      In Summary

      Patients trust us to provide the best possible care and clinical trial experience for them.

      As an industry, we must shift to prioritize technology and tools that make it easier for patients to participate throughout the study’s duration. Even using a simple interactive SMS dosing manager can significantly increase compliance, improve safety, and reduce cost and risk. So, let’s work together to help patients, their caregivers, and their families succeed in our clinical trials.

      References

            1. Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Blaschke TF1, Osterberg L, Vrijens B, Urquhart J., Annu Rev Pharmacol Toxicol. 2012
            2. Smith, Dorothy PharmD, Patient Nonadherence in Clinical Trials: Could There Be a Link to Post Marketing Patient Safety?, Consumer Health Information Corporation, October 2011
            3. Improving Medication Adherence in Cardiometabolic Disease, Journal of the American College of Cardiology, 2017

        author avatar
        Sridhar Gumudavelli
        Sridhar Gumudavelli serves as the Vice President of Formulation R&D at Renejix Pharma Solutions, where he brings a wealth of knowledge and experience to the table. His leadership is instrumental in navigating the complex process of drug formulation, leveraging a variety of technologies to enhance drug absorption, bioavailability, and patient compliance.Sridhar’s expertise is not just limited to his hands-on experience; he is also an innovator with several patents filed under his name. These patents reflect his contributions to advancing drug delivery systems, showcasing his ability to tackle some of the most challenging problems in pharmaceutical sciences for the past 30+ years.

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