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Unlocking the Future of Clinical Trials: The Critical Role of Patient Adherence

In an exploration of the critical facet of patient adherence in clinical trials, Aad R. Liefveld from Link2Trials, a partner of the BEAMER project, sheds light on the profound impact adherence has on global health, pharmaceutical decision-making, and the successful outcomes of clinical trials.

In this two-part series of articles, Aad speaks about available innovative solutions to improve adherence behaviour today and not tomorrow. In part one, we will identify the severity of the issue, as it concerns both public health and pharmaceutical company finances, and describe the conditions that contribute to nonadherence to treatment. In part two, we will explore the benefits of adherence to treatment for patients, payers, and regulators, as well as offer ways to improve adherence behaviour now.

In the first article, the substantial societal and economic costs linked to non-adherence in clinical trials, emphasise the importance of addressing this issue. Click here to read

The second article provides insights on improving adherence, presenting an opportunity for stakeholders to enhance products in the market while reducing costs. Click here to read

Billions Of Reasons To Improve Adherence

“Treatment adherence is the process in which the patient engages in a health, technology, or medication-enabled treatment, which was discussed and agreed upon together with a healthcare professional. Adherence includes meeting the following conditions that are relevant to the treatment”. See here for more information.

This article highlights the connection between non-adherence and significant societal and economic costs, particularly in certain types of clinical trials which is crucial for stakeholders to understand the urgency of improving adherence.

Promoting Better Adherence for a Healthier Tomorrow

In another article, Liefveld underscores the significance of adherence in optimizing the success of any treatment. In his latest contribution, he emphasizes the role adherence plays in reducing overall healthcare costs and societal expenses related to sick days. Governments worldwide, focusing on healthcare cost reduction, base their decisions on data from clinical trials. However, real-world efficacy often falls short, contributing to unexpected healthcare expenses.

Consequences of Low Adherence

The article outlines the adverse effects of low adherence, including reduced treatment efficacy, increased side effects, elevated risk of complications, and a higher likelihood of hospitalization and mortality. Liefveld advocates for prioritizing drugs or medical devices with high adherence levels, even if they come at a higher cost, stressing the importance of considering both efficacy and affordability in treatment decisions.

Unique Selling Proposition (USP): Real-World Adherence Levels

Liefveld introduces the concept that delivering drugs and medical devices with high real-world adherence levels can become a decisive Unique Selling Proposition (USP) for pharmaceutical companies. With healthcare systems shifting toward value-based pricing models, providers are incentivized to ensure patient adherence, leading to improved outcomes and reduced costs.

Innovative Solutions for Higher Adherence Rates

The article delves into innovative solutions to enhance adherence, such as digital pill bottles that track medication intake and personalized adherence support programs. These programs, driven by adherence data analytics and patient-centred design, aim to identify and support patients at risk of low adherence.

Crucial Role in Reimbursement Decisions

Liefveld highlights the importance of adherence to regulators and payers in reimbursement decisions. While adherence levels in clinical trials are deemed rigorous, real-world adherence data, obtained through various methods like pharmacy claims and patient surveys, provide a more realistic picture. Regulators and payers increasingly use a combination of clinical trials and real-world adherence data in decision-making, reflecting a growing acknowledgement of adherence’s role in achieving optimal patient outcomes.

Improving Adherence in Clinical Trials: A Necessity

Recognizing the significant costs of nonadherence in clinical trials, the article outlines actionable steps to improve adherence. These include patient education, simplifying trial protocols, personalized support programs, leveraging digital technology, and closely monitoring adherence with timely feedback.

A Personal Commitment to Adherence

In a heartfelt note, Liefveld shares his journey into the world of adherence, driven by a passion to improve patient support during clinical trials. He introduces the BEAMER project, an innovative initiative aimed at addressing early dropout rates, improving patient experience, and ultimately making healthcare more sustainable.

Supporting a Healthier Future

Liefveld concludes by urging readers to support initiatives like the BEAMER project and actively incorporate adherence-supporting solutions in their organizations, emphasizing that improving adherence is not just a professional goal but a personal responsibility for the betterment of society.

Click here to read the article on “Why — And How — To Improve Adherence To Treatment In Clinical Trials” and here for “Understanding The Effects Of Non-Adherence To Treatment In Clinical Trials”

 

ACKNOWLEDGEMENT & DISCLAIMER: The project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101034369. This joint undertaking receives support from the European Union’s Horizon 2020 Research and Innovation Programme, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Link2Trials.  This communication reflects the views of the authors and neither the IMI nor the European Union, EFPIA, or Link2Trials are liable for any use that may be made of the information contained herein.

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Supported by a grant from IMI, the project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101034369. This joint undertaking receives support from the European Union’s Horizon 2020 research and innovation programme, the European Federation of Pharmaceutical Industries and Associations [EFPIA] and Link2Trials. The total budget is 11.9 M€ for a project duration of 60 months.

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Information on this website reflects project owner’s views and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

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Healthcare Professional

The primary aim of the end user personas is to support the creation of materials to support the implementation of the BEAMER model framework and to help define requirements for the elements of the BEAMER model framework. Hence, healthcare professionals (HCPs) represent the primary envisaged end user group of the BEAMER model framework and the associated Adherence Intelligence Visualisation Platform (AIVP)

It is one learning from the joint design process that the job titles of healthcare professional team members do not necessarily predict the roles they would play within the change management process for implementing BEAMER and installing it as a standard model within healthcare. Additionally, the role and responsibilities of certain job titles, for example nurse, varies across different healthcare systems and would affect how they interact with the BEAMER model outputs and the access they would be permitted and so it would not be helpful to include these job titles: The four personas represent role-independent archetypes within the group of HCPs. They encompass a Managerial HCP Persona, an Implementer HCP Persona, a Support HCP Persona, and a Established HCP Persona.

These healthcare professional personas may be further tailored to specific healthcare settings depending on the needs of the individual pilot sites. Thus, adapted or spin-off versions of these original personas may be considered. The persona displays include a summarising statement, goals, challenges, experience, and needs to enhance the accessibility and usability of the model while minimising user burden.

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Patient Organisation

Patient organisations are considered potential users of the model outputs. Consequently, personas were designed for these groups to assure that the implementation materials may also support their needs in the longer term, thus fostering sustainability of the project outputs.

The identified focus areas within this persona are goals, needs, skills and tools, along with potential challenges anticipated during the implementation process. The persona emphasises awareness-raising, capacity building, education, peer support provision, and the promotion of research and development in therapeutic care.

The patient organisation persona serves as a theoretical framework representing how patient organisations could benefit from and include the BEAMER model framework in their therapy and care related as well as their organisational work. This persona comprises the needs, goals, challenges and necessary tools, facilitating preparation and implementation of the model and optimising the user experience of patient organisations as end users of the BEAMER model framework. It can be used as a guide to identify potential obstacles and understand the prerequisites for a patient organisation to successfully adopt and integrate the BEAMER model framework.

“In implementing the BEAMER model, we want to be able to respond to the different needs of our patients to ensure their adherence, build a supportive community and improve outcomes.”

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