The demand for patient centricity in clinical trials has been growing for years, and the pandemic only amplified this expectation. Patients experiences with decentralized clinical trials (DCT) and remote healthcare, in general, proved that trials can be adapted for a remote world. When it's done right, it can make these interactions better, easier, and more efficient for everyone involved.

Over this same period, advances in data analytics make it possible to create an experience that meets individual patients needs. These insights can transform a trial from a generic one-size-fits-all experience to an agile environment adapted to individual patient needs.

Let the data guide you

Patient centricity is about more than just reducing travel times or using technology to ease access to documents and investigators. While these decisions ease the patient burden, a truly patient-centric trial is about building the trial experience around patient needs knowing that those needs will vary. Where one population may prefer digital tools for every engagement, others will want more facetime with investigators or some visits with their local doctor.

If sponsors use an agile approach when planning, these preferences are valid and can be accommodated in the trial. The key to achieving this is by using real-world data, analytics, and patient feedback to understand the patient journey and shape the trial around the detailed insights they uncover.

An effective analysis process can help sponsors find patients of interest and understand where they are in their disease journey. It can also provide information about when and why patients are diagnosed, what treatments they receive, what outcomes they experience – and how these trends vary across different populations.

This data isn't hypothetical or an amalgamation of all patients in a specific disease category. Current technology can provide detailed insights into individual patient experiences, which sponsors can use to find actual patients, not just profiles. For example, the data might show that patients in urban settings or those near centers of excellence are diagnosed sooner and follow more aggressive treatment regimens than those in other communities. These insights can customize recruiting and outreach for different populations, allowing sponsors to adapt every ad and interaction for the unique populations they are trying to engage.

Technology finds a needle in a haystack

The unprecedented access to patient data is also helping sponsors recruit for much smaller studies that target specific populations of patients for highly targeted therapies. For example, a large pharma company had a global initiative that involved identification of patients with a rare progressive cardiovascular disease. After trying for one year none of the participating research sites across three countries were able to find a single patient.

A research site leveraging the IQVIA CTcue technology platform was approached to search for patients. CTcue mines structured and unstructured patient data using natural language processing (NLP) to help research teams identify patients and review their records using a practical and iterative approach.

Working with the Cardiology team at the research site, a database of over 100,000 patients was analysed. This search narrowed the pool of patients down to just 22 with multiple risk factors indicative of the disease. A review of these 22 records by the cardiologist ultimately identified 3 patients. Follow up activities resulted in one newly diagnosed patient; the first patient identified globally for this initiative. This identification optimization all occurred in less than four months

Personalized trials

Along with finding patients, sponsors can use these analyses to adapt the trial experience to their needs while still meeting the trial design's data rigor and regulatory requirements. Patient preferences may determine what wearable devices or apps are used in the trial, how many site visits are required, and what additional support they provide to patients to ensure they can access their medicines and complete at-home observation activities.

Once study teams find patients of interest, they can leverage technology solutions, like IQVIA's Patient Portal, to make the recruiting and participation process seamless and customized for every participant. Patient Portal provides patients with access to selected data share-back, interactive education, and gamification, all in a single location. Telehealth platforms, e-diary integration, and connected wearable devices will be delivered in upcoming releases.

It makes it easy for patients to find the information they need, complete tasks, and interact with forms and staff in ways that are engaging and responsive to their needs, even if they can’t meet face-to-face.

The new normal

If sponsors want to make this kind of engagement a permanent part of the trial environment, they must make patient data analysis part of every trial planning process and work with partners who understand how to leverage data analytics to make their trials more engaging for every patient.

The most forward-thinking sponsors are already using data and analytics to personalize study experiences, including finding patients of interest, what outreach strategies they use, and how they define inclusion/exclusion criteria for targeted patient populations. It is helping them identify hard-to-find patients and streamline their outreach and trial experiences to eliminate barriers and make research a more appealing care option for every patient in the community.