How to improve clinical trial adherence through patient-centricity

Clinical trials are incredibly costly and threatened by patient non-adherence. A patient-centred design approach increases patient engagement and improves adherence.

Danusch Mahmoudi

Discussions among industry experts suggest that scientists don’t consider patient non-adherence when designing trials - a fatal flaw that leads to unpredictable costs. Putting patients at the centre and prioritising their needs, preferences, and experiences could revolutionise patient engagement, improve adherence and ultimately transform the medical research landscape.

Getting a grip on the huge costs involved

The number of clinical trials is increasing, as is the amount spent. Since clinicaltrials.gov began registering clinical trials worldwide in 2000, it has received 447-472 trials, representing an expenditure of 285,000,000,000 US dollars on research and development.

Approximately 27% of this budget, or $77 billion, is spent on patient recruitment. On average, it costs 6,533 US dollars to recruit one patient for a clinical trial. The cost of replacing a patient who drops out of a trial due to non-adherence is even higher – three times as much. It’s important to note that a linear increase in non-adherence exponentially affects the number of patients needed to achieve the same statistical result. Increases in data variability mean that study teams need to enrol more patients to complete the study’s statistical outcomes.

To illustrate, an IMP (investigational medicinal product) non-adherence rate of 20-30% requires a 50% increase in study sample size to maintain equivalent statistical power; once non-adherence increases to 50%, the study sample size must increase by 200% to maintain equal statistical control. That's why non-adherence costs an average of 19,533 US dollars per patient.

Patient dropouts also cause study schedules to slip, unexpectedly increasing study budgets. For niche products, this means lost revenue opportunities of 600,000 US dollars per day – and up to $8 million US dollars per day for blockbuster medical products!

In addition to the financial cost, losing patients during a clinical trial is a significant loss of valuable data, as new patients have to be enrolled from scratch. It can also compromise the integrity of the trial. In the worst case, the trial is stopped due to insufficient data, evidence, or feasibility.

These factors and costs highlight the importance of patient retention, especially considering that approximately 30% of patients drop out of clinical trials. To mitigate the consequences of dropouts, it’s important to focus on patient retention and patient-centricity in trial design

Addressing various barriers to adherence

Understanding and addressing the reasons behind patient dropouts is crucial to improving patient retention and reducing dropout rates. Some of the reasons why patients may choose to discontinue their participation include:

Burden & complexity: Clinical trials often require a significant time commitment from patients, including frequent hospital visits and assessments. If the trial protocol is overly complex, restrictive or requires considerable lifestyle changes, patients may find it too difficult to comply.

Lack of appreciation & good communication: It’s important to ensure that patients feel valued and understand the importance of their participation in the study. Inadequate communication or misunderstanding about the trial procedures, risks, and benefits could lead to patient dissatisfaction.

Uncertainty & fear: Patients may have concerns about the safety of the trial, potential long-term effects of the intervention, or ethical considerations. Some may drop out in placebo-controlled trials if they suspect they receive a placebo and not an active treatment.

Unclear expectations & condition stagnancy: Not all patients will experience improvement, especially those in control groups. Patients may be discouraged by a lack of progress or side effects if their expectations are unmet.

Of course, individual reasons such as family commitments, loss of interest, medical problems and much more can be reasons for dropping out.

Incorporating design principles in clinical trial schemes ultimately results in better outcomes, increased satisfaction, and improved clinical research delivery.

Design boosts patient adherence

Design can significantly impact patient adherence in clinical trials by prioritising empathy for the patients and focusing on enhancing their experience. That requires a holistic understanding of patients' needs, preferences, and challenges.

Through various methods and frameworks, a design-driven approach involves patients from the initial design, through recruitment and data collection, to completion and reporting of results.

‘It’s amazing the things you can do when you shut up and listen to your patients.’

Patients are the experts, and as designers, we need to listen to them. To develop a truly patient-centred experience, you first look at the needs and challenges of all stakeholders: Patients, clinicians, and treatment centre staff. Often, people don't know what they want until you show it to them. The goal is to find out. And then to translate their needs into powerful value-added services

Patient-centred design unlocks the full potential of clinical trials

The added value of design comes from actively listening to and managing the many stakeholders. Through co-creation, participatory workshops and other formats, the designers explore the perspectives of patients, their families, and all the professional groups involved and incorporate their needs into the new processes. They empower multidisciplinary teams to identify solutions that are coherent for all stakeholders. This makes the trial more enjoyable, inclusive, and transparent for all involved. Incorporating patient feedback throughout the trial design process and continuously evaluating and refining the design based on participant experiences can improve patient adherence in clinical trials.

Shaping the future of clinical trial

Working closely with patients ensures that all materials, protocols, and policies reflect their preferences and needs. Among them are:

Clear and accessible information is visually appealing and easy to read using plain language that considers different literacy levels and preferences. The material presents information structured and organised to enhance comprehension and increase their commitment to the trial.

Trial protocols and procedures are convenient and inexpensive, e.g., by minimising the number of clinic visits, considering remote monitoring, or enabling data collection at home.

User-friendly interfaces for patient portals or mobile apps are intuitive and visually appealing. Additionally, they should be inclusive and accessible to a diverse range of users, including older adults or those with limited technological literacy.

Patient support programs can help foster a sense of connection and support by providing additional resources and assistance. These may include transport services to overcome barriers to attending appointments and support apps that provide information and resources to help manage the side effects of treatment.

The power of design

Transforming health means collaborating with partners and stakeholders. We know how to work closely together with patient groups, scientific institutions, start-ups, HCPs, hospitals, technology- and health experts.

The power of user-centred design was demonstrated in our project for a clinical trial at The Charité - Universitätsmedizin Berlin to redesign clinical workflows. After six months, the results were clear: The user-centred design approach has a demonstrably positive impact on patients and medical staff and contributes to the success of clinical trials.

Design can make sense of the complexity of healthcare and optimise processes. It can accompany change and transformation and help create essential added value for people - the most important thing in medicine.

Want to gain insights into the benefits of putting patients at the centre of research? Reach out to our Managing Director, Danusch Mahmoudi.