Easing the Patient Journey: New Technologies, Improving Diversity and Rigorous Standards

Originally appeared on pages 20-22 of International Clinical Trials, Autumn 2024

By: Julia Lakeland, uMotif

My daughter was three years old when she was diagnosed with type 1 diabetes in 2014. That moment instantly changed our family’s lives. At that time, I had been in the clinical trial technology industry for 15 years, and I knew of the potential impact clinical trials could have on patients’ lives. When doctors offered us a late-phase paediatric study of insulin pumps to control her blood glucose levels, we did not hesitate.

The overwhelming benefits – and burdens – of using a plethora of study-related technologies have stayed with me. Even with the many strides that have made in improving clinical trials, more must be done to focus on the patient journey to ensure that accurate and valid protocol-specific data is captured. It is the key to improving the clinical trial patient’s experience, and to achieving better outcomes and faster trials.

Putting the patient’s voice at the centre of a clinical trial requires careful consideration of three vital areas:

Patient-centric technologies: we must develop new solutions to improve patient engagement and reduce the emotional and logistical burdens of participation, while maintaining rigorous data integrity and validity
Personalised trial experiences for diverse populations: we must address the lack of diversity by incorporating factors such as age, access to resources and cultural norms, to foster inclusivity and equitable access to research participation
Ethical considerations for privacy, informed consent and data security: these areas are vital when developing and implementing new technologies to collect and analyse patient data.

Patient-centric technologies

Developing new medical treatments to improve health and well-being requires data that is scientifically and clinically meaningful. But the quality of the data is only as good as what we can capture. Maintaining patient compliance to the protocol requirements and a high level of interaction with the patient is paramount. Patients are experts in their disease journey – they live with the condition day in and day out. In designing a trial using digital technologies, it is essential to cultivate a deep understanding of the challenges each patient faces every day. It is therefore important to seek patients’ input at the early stages of design and development and incorporate that feedback in a way that optimises the user experience while ensuring effective data collection.

Whatever solution is presented, it must be easy to use and be of benefit to the patient. Technology must not add to the already overwhelming burden of living day to day with a serious, and often chronic, medical condition or disease. Empathy is a vital component of technology development. We can gain an appreciation of patients’ realities through working with advocacy groups and speaking with the general population. We then must leverage that understanding to create technology and solutions that improve patient engagement.

Patient-centric technologies provide the flexibility to include different sources of data within the boundaries of the protocol design, which focus on real-world evidence that is specific to the patient’s lifestyle. It also helps build continued trust between the patient and their doctor – a relationship that is ranked of high importance to both parties. Including technologies, such as a wearable device, as part of a wider digital clinical trial design that includes telehealth, remote monitoring and patient-friendly study information through a single application, can bring two worlds together. This way, the value of the data is captured while keeping participants well informed about when and how they need to interact.

While it is vital to put the patient first, we also have to work within the boundaries of what the technology can do and what regulators will allow. The validation and verification of the data is a constant, but the patient experience can vary considerably.

Over the past ten years, my daughter and I have used an abundance of continuous glucose monitors, insulin pumps and pens to capture data, with some methods being more accurate than others. But we are seeing progress in our industry’s growing adoption of healthcare devices and mobile phones, and when I look at my daughter’s life now compared to ten years ago – her independence, the granularity of the data she captures, the scientific support and improvement in her overall well-being – it continues to be a remarkable journey.

Personalised trial experiences for diverse populations

Increasingly, regulators are requiring more diverse trials. As such, technologists need to develop solutions that personalise the trial experience for diverse patient populations. When you look at statistics around who typically participates in a clinical trial, there is an imbalance. Historically, people from certain racial and ethnic minority and other diverse groups have been underrepresented in clinical research. There are a host of financial barriers associated with trial inclusion. Other common reasons patients cite for declining to participate – and which help explain the overwhelming dropout rates – include inconvenience, time commitments, poor communication and a feeling of being underappreciated. There is a great deal to consider when we look at how to render a clinical outcome assessment (COA) or patient-reported outcome (PRO) for diverse patient populations. It is crucial to build adaptability into the configuration of the trial design to meet the needs of each patient group, and every patient within that group.

Considerations relevant to diverse patient populations can include font and screen size, and device controls. If a wearable is being selected, it has to be demonstrated that the sensor is easy and reliable for that patient population to use. We also need to know that there has been verification and validation to make certain that the sensor is suitable and practical to the purpose. The January 2024 FDA guidance on digital health technologies requires that they be ‘fit-for-purpose and assessed for usability by the identified patient population within the intended remote setting, without errors or problems being encountered’.1 The guidance recommends that a usability evaluation be conducted to demonstrate the successful verification and validation of the study design in accordance with the patient population.

In addition to design considerations, the importance of language and culture as potential barriers cannot be overstated. Cross-culturally, we need to understand the different perceptions individuals might have about clinical research. Understanding how people want to interact with the technology we are asking them to use, and tailoring it to their expectations, is a given.

Another area for discussion centres on the availability of digitalisation and local country logistics in developing and transparency between patients and researchers throughout the trial process. For example, consider that a sponsor wants to conduct a phase 3 trial in multiple regions across multiple countries. To eliminate the risk of bias and ensure integrity to data analysis, the ideal solution is to implement the same solution across all global regions. However, local country restrictions specific to device manufacturing, customs and imports can be challenging. If you want to design a digital trial across the EU and US with remote visits, wearables and patient sensors, and remote data capture, you must determine if the devices have the correct licences and approvals to demonstrate medical device regulation (MDR) certification in the EU and 510K compliance in the US.

During the pandemic, clinical research pivoted toward the use of wearables, and remote patient monitoring and visits increased. Among the lessons our industry learned is that a one-size-fits-all approach is not feasible. Incorporating empathy in protocol and technology design gives us invaluable insights into how to optimise engagement and communication with the patient.

Ethical considerations for privacy, informed consent and data security

There must be trust and informed decision-making within the entire cycle, no matter where we are within the element of science and research. Creating a continuous level of communication between the patient and the site is vital.

Regardless of the device or sensor being used, a communication plan within the study protocol and a design that is based around the needs of each patient must be developed. Options can be provided as to how content within an app is rendered. There are numerous considerations about making sure the correct open channel is available: that patients feel they are supported; that they have the right information at their fingertips; and that the information is easy to access and secure.

When implementing eConsent, it is vital that the solution demonstrates regional compliance. Not only does the workflow need to be able to support file versioning and accommodate multiple, remote signatories, it also requires the ability to combine electronic signatures and wet ink uploads, as well as presenting informative content that is intuitively displayed to the patient. This is to ensure that they fully understand what they are consenting to.

When there is new technology such as a wearable, we need to place the patient’s experience at the heart of design and development. Understanding and minimising the patient burden is essential, because whatever solution is presented to that patient, it must be easy for them to use. Patient data privacy also must be maintained and any personal data is captured, processed and stored in accordance with the clinical study protocol.

Other ethical considerations focus on offering the patient options in how they access the trial technology to capture their data. Within the study bounds, offering a ‘bring your own device’ (BYOD) option can help achieve high engagement levels, because a patient has the ease and convenience of using a device that likely is part of their daily routine. However, not every patient will have access to a smartphone or tablet, or they might not want to use it for the trial. Therefore, patients need to be offered access to provisioned devices as well, to make the study accessible and available.

There also needs to be alternative communication methods offered for patients beyond words, such as visual diagrams, cues, videos, texts and speech. Making sure you know what additional information patients may want, and how they want to receive it, will guide them through their trial journey and make the experience more meaningful, useful and personal. Understanding their experiences and making the technology easy to use helps capture more data. On the backend within the system, capturing and validating that data, it needs to be confirmed that it’s suitable for clinical research purposes – an end-to-end spectrum must be achieved.

All these aspects of clinical trials come together to help ensure patients are engaged, willing and able to capture a data flow that is reliable, accurate and compliant. By putting the patient at the heart of clinical trials, technologists can help to speed the delivery of new treatments to those who are waiting.

About the Author

Julia Lakeland is chief product officer at uMotif, which provides an eCOA/ePRO platform for patient data capture in clinical trials and real-world studies, and site solutions including eConsent. She is passionate about improving the research patient experience and delivering products and services that enable new treatments to be brought to market safely and quickly. With more than 20 years in the life sciences industry, Julia’s expertise includes product management, operational delivery and support of phase 3/4 clinical trials, and clinical technology systems including logistics and digitalisation.

Reference:

Visit: fda.gov/regulatory-information/ search-fda-guidance-documents/ digital-health-technologies-remote-data-acquisition-clinical-investigations