Digital transformation of clinical trials – are we thinking about the patients yet?

Successfully moving activity on a clinical trial from a site-based to remote (i.e. moving from traditional setup to a hybrid/decentralized [DCT] model) will require the adoption of a “digital-first” mindset. While it is key that the digital solutions used to deliver high-quality data required by the clinical researchers to meet the objectives of the protocol, it is also becoming increasingly important that the solutions are designed with ease of use by the end user (in a remote study – often the patient or a nurse who is not immersed in clinical research) in mind.

Digital transformation of clinical trials has been underway for many years, but as expected in this tightly regulated and conservative environment, progress has been slower and steady at best. While Electronic Data Capture (eDC) enabled the posting and faxing of Clinical Report Forms (CRF) to be replaced with “real-time” entry of data into an electronic CRF (eCRF) at the clinical site over 20 years ago, it is still considered a novelty to enter data directly into the eDC software, rather than paper-based CRFs. The widescale capture of patient-reported outcomes (PRO) from patients in an electronic format (ePRO) has strong evidence that it increases the compliance of data captured despite the fact that the site has been slow, as the industry debated if data captured on a screen was equivalent to that captured on paper. Though we may now have arrived at a tipping point where eDC is adopted on new studies as standard endpoint, ePRO is often used as a primary or secondary endpoint. Moreover, with other technological advancements, the breadth of digitization has increased quickly with the ability to create and interrogate large datasets by adding value around recruitment and sophisticated wearables allowing continuous data capture from the patients whereas earlier a simple blood pressure still required a visit to a clinic, and most of us carrying a mobile computer around in our pocket. Undoubtedly, Covid-19 is a catalyst that allowed the traditional hurdles to adoption to be (temporarily) put to one side so as to prevent research being stopped altogether. Having seen what is possible, the industry seems keen to continue progress and industry bodies, such as the Decentralized Trials & Research Alliance (DTRA), have been setup to maintain this momentum.

While the pharma industry is interested to consolidate and build on the increased adoption of digitization when running clinical trials, the landscape within which this research occurs has also changed posing a new challenge. The shift to conducting some trial activity away from the site means the end user of technology has also changed, with tools often directly in the hands of patients, or clinical staff who are unfamiliar with conducting clinical research. While the mobile computer (or mobile/cell phone as it is still called) has created a wide range of opportunities to capture data directly from patients, this daily access to technology has also reset the patient’s expectations of what an enjoyable user experience is. A patient with a phone in their pocket, and who is also generally technology savvy, can now engage with digital solutions that researchers would like them to utilize for capturing complex data at the right time. The key question therefore becomes, does the patient want to fill this role if the experience is clunky, as they have many more interesting things to do on the phone instead and does a clinical research app even make it to their home screen ahead of Facebook, Instagram, Twitter, etc. These dynamics change as we move into elderly populations where they are more concerned around ease of use. Moreover, the underlying issues are that, will and can the digital interaction with such patient population easily contribute to your research, or do they give up and leave the trial or collect partial data.

The post-approval real-world landscape is where most patients engage with healthcare providers and treatment regimes. This less structured environment where the patient is central and which needs to be agile around their needs, is already the home to large volumes of clinical research. The lessons learnt in this environment can help educate clinical trial designers as they themselves try to ensure their research is more patient-friendly, and increasingly digitized approaches are adopted, often away from a classic brick and mortar site. Positively, the very use of technology to allow research to be conducted at a location of choice for the patient can empower the patient and reduce inconvenience and can also help ensure that a more diverse patient population takes part. Where the use of technology has been most successful in the real world, it would also seem that the success is often driven through providing something informative to the patient. This may be a reinforcement that the research they are conducting is going to help patients, such as providing regular study updates or providing easy access to information about their condition and the broader research landscape including links to patient communities. In other scenarios, the patient may benefit from knowing more about their own data and how it can be compared with their peers, or what actions they can take to address their own health based on the data they collected.

Not everything that can be applied in a real-world healthcare setting can be utilized within a carefully controlled clinical trial, as there are differences in the regulatory landscape and within an interventional landscape, and it may be more important to control other factors. Hence, it is important to start thinking about how clinical trials (and the related technology) be designed with the patient in mind and to be more “patient-centric”.

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