The vast majority of patients who take part in clinical research – more than 98 percent – express interest in participating again, but, unfortunately, the majority are not asked to do so. Far too often, trial sponsors engage patients for the purpose of collecting and extracting data, and then move on without acknowledging patients’ contributions. This transactional approach leads to poor patient experiences and contributes to recruitment challenges and trial delays.

To ensure the long-term success of clinical research, we cannot underestimate the importance of engaged individuals prepared to participate in trials. Generating this interest requires a continuous process where patients feel empowered, engaged, and educated about clinical trial opportunities. This means supporting them to find the right clinical trial, guiding them through the process, and, in the end, enabling them to learn from their experiences by sharing data and health outcomes information and engaging them in long term safety follow up.

This is the promise and power of decentralized and hybrid clinical trials (DCTs), which already break the traditional mold of site-based studies with their unique ability to engage individuals outside of traditional clinical trial sites. Regardless of factors like geographical location or socioeconomic status, DCTs allow researchers to access a broader and more diverse audience, producing better results reflective of the population under study. Decentralizing technologies, like wearable sensors, produce continuous data sets and provide researchers with new clinical insights, digital biomarkers, and digital endpoints.

However, as DCTs can shift the study site to the patient’s home, doctor’s office, or anywhere else, the focus of the entire effort must shift as well by putting patients at the center of the clinical development process.

Engaging patients with a high-tech and high-touch approach

Clinical trials are often perceived by patients as a last resort, when in fact they can represent the very best of our future. The scientific advances occuring in our field today are beyond anything we could have previously imagined; however, as with any new clinical advancement, we must ensure patient and site experiences are considered alongside our technical achievements.

Historically, clinical trials have not prioritized the experiences of patients, who are required to frequently return on-site and engage with unfamiliar medical technology. They are often left in the dark regarding the data and health outcomes being collected through their participation and rarely thanked for their contributions to medical progress. Additionally, most studies are designed without the input of the participants, further limiting our ability to understand and reduce patient burden or improve enrollment, retention, and experience.

The upside is that clinical trial sites are increasingly embracing technology, and many are using changes made during the pandemic to spur greater adoption of patient-focused options. A survey (“Site Perspectives on Decentralized Clinical Trials”) by the Society for Clinical Research Sites and Medidata in 2022 showed that most sites anticipate using patient-facing technologies to collect clinical data in the next two years.2 Sites are also planning to increase their use of eConsent, embrace the use of sensors and wearables, and dramatically increase the use of televisits near term. Sites may need more reliable wifi or upgraded devices to adopt decentralizing solutions, and sponsors should provide adequate time and compensation for additional training and improvements. Because DCTs are not only focused on new technology, but also increased choice for patients, sites and sponsors should remember that some participants may prefer traditional, in-person or paper-based options and be willing to accommodate them. In addition, these flexible solutions improve the patient experience by providing adjustable timing for study activities, limiting travel requirements, and speeding up study timelines.

With DCTs, we can offer both a high-tech and a high-touch approach with trials that are developed and designed, in part, with patients and caregivers. It’s important to include a formal process that infuses the patient perspective into the clinical software development life cycle can create technical solutions that improve patients’ experiences and satisfaction. This can provide a range of opportunities to share patient perspectives, not just at the end of the process but throughout. For example, solutions such as sensors, live video visits, and intuitive mobile apps can enable continuous patient participation that integrates more smoothly into their everyday lives outside of clinical trial sites.

At the same time, this high-tech approach will not only improve protocol adherence but also reduce overall burden on sites, so that they can focus on what they do best: providing care for and establishing trust with patients. Sites can spend less time on administrative tasks, as well as training on and overseeing disparate systems, when using a unified DCT platform that provides all solutions under a single login. By employing technology that engages patients where they are, sponsors can make sure trial participation provides patients with meaningful results for their time and contributions and is not just a transactional experience. For example, sponsors can continue engaging patients after they complete a trial by supplying publication updates, patient data return, and information on future trials of interest through post-trial registries.

Considering patient needs 

The easier we make clinical trial engagement for patients, the better their experiences will be. This process must begin with careful consideration of the burdens patients face when participating in studies – how long it will take them to travel to trial sites, if they own or can use a smartphone, unnecessary or duplicate sample collection, if transportation/travel options are accessible, etc. The patient experience also includes overlooked elements such as convenience and cost of parking and comfort of the trial facilities, which influence patients’ willingness to continue to participate.

Cultural customs must also be considered. eConsent, protocol instructions, and medical terms, for example, must be clear and relevant in order to be effective without creating undue stress or raising concerns. This empathic approach and focus on relevancy can help to build trust between providers and patients, particularly within racial and ethnic minority communities. 

A greater focus on the patient can also increase trial visibility and access by using the most appropriate, targeted information channels. These include digital advertising, social media, advocacy groups, and direct-to-patient advertising. Broadening access also empowers patients to learn about and register for clinical trials in which they are interested, ultimately creating a cycle that continuously engages patients and nurtures trust in our healthcare system.

Democratizing patient choice 

Allowing patients to play an active role in how they participate in the clinical research process is critical to keeping patients engaged; flexibility is the key. Sponsors, sites, and CROs can make a powerful, affirmative statement by encouraging participants to utilize the devices that are best suited to their personal needs, such as laptops, desktops, tablets, and smartphones, and offer the ability to choose their preferred location for participation. A flexible, patient-centric, decentralized approach can help ensure that study populations better represent the patient populations that will ultimately benefit from new therapies, vaccines, and medical devices.

Using the right mix of decentralization technologies, we can also power faster enrollment, increase participation and retainment, and, ultimately, bring new advances in healthcare to market more quickly. By engaging patients before, during, and after clinical trials, we can both create protocols that are scientifically rigorous and offer a meaningful experience that patients can trust and repeat.

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