From trial design for patients to trial design with patients: a key topic at DIA ’22

At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health and digital data partners and more to navigate challenges in drug development that impact patients globally.

As an industry, we recognise patients as partners in the development process, but if we aim to enhance the patient experience in clinical trials and ultimately, improve patients’ lives, we need to continue to consider how we keep the patient front and centre in drug development. This discussion was top of mind at DIA, especially as we looked ahead to patient-centred drug development in a post-pandemic era. In fact, DIA 2022 was officially designated as a “Patients Included” conference, emphasizing its commitment to inclusivity and integrating patients into discussions as experts in their conditions and experiences.

Tearing down information silos and talking through concrete ideas to help shift from drug development for patients to drug development with patients, I shared several actionable steps with DIA attendees.

Patient journey

Patients are at the heart of drug development, so this is where planning is key. Considering the patients’ voice, preferences, burdens/barriers, social determinants, etc., and fully engaging and informing them before, during, and after trials is critical to successful patient-centric trials. Gaining insights from patient and caregiver surveys, patient advocacy groups and others can help us secure perspectives. Active social listening, using the breadth of real-world data insights available to us, including patient journey by country, helps us better understand disease landscapes and patient behaviours and expectations to inform engagement strategies. Importantly, patients are taking a front row seat in their clinical care decision making and demanding (rightfully) more personalized medicine. We must meet patients where they are and ensure implementation of agile trial methodologies.

Patient centricity also means designing protocols that recruit and retain the right patients for individual trials. This means designing or evaluating protocols for elements that impact enrolment, including reducing patient burden, patient-site friction, and competitive trials.

Patient access

When designing trials, sponsors, and clinical research organization (CRO) partners need to focus on increasing diversity in trials. Our industry has a long-standing commitment to expanding trial access and participation, especially among traditionally underrepresented populations. However, with COVID-19 re-emphasizing gaps in trial diversity and inclusion, there is a renewed focus on doing more, especially as we can leverage deep expertise and transformative technologies to knock down long-standing barriers.

To increase patient engagement, we should consider:

Culture and trust: We need to secure an understanding of what individual patient populations need to participate and stay engaged. Local community partnerships and real-world insights can help.
Site selection: Factoring in diversity when determining target sites helps strengthen awareness and engagement among key patient populations. Using machine learning, we can extract trial protocol details, site features, previous performance, claims data and patient demographics at trial sites to produce a ranked list of ideal trial sites that serve diverse patients. Sponsors and CROs can also support and upskill research-naïve sites where target patient populations receive care and train minority physicians to participate in research too.
Socioeconomic variables: Transportation, general trial awareness, health literacy levels, preferred language, access to healthcare and more is important to gauge per population.
Site and patient needs: Keeping individual needs in mind throughout the entire trial process can help sites meet their goals. Direct-to-patient advertising, referral networks and validated recruitment strategies help with engagement. After trials, culturally-informed communications and understanding burdens and barriers can ensure participants maintain a thoughtful connection to the trial.

Delivery models

It’s vital we know what’s necessary to interest patients and sites in trial participation. At DIA, we presented findings from a 2021 global survey of patients and study investigators conducted by IQVIA, which showed that both groups are interested in decentralized trials (DCTs). Approximately 95% of surveyed investigators indicated interest in hybrid DCTs, trials enabling participants to perform some tasks away from trial sites. Most patients appreciated the flexibility offered by DCT options like telehealth and in-home care. More than 80% of patients were comfortable using apps to report symptoms and other relevant information.

Engagement, retention, and follow-up

Creating a consistent experience throughout the trial partnership helps personalize engagement for participants. Sponsors and study teams can initiate engagement by using an analytics-driven strategy to target and create awareness among the right patients. Hyper-customized communications through social media, pharmacies, and more can increase the likelihood that patients will respond.

Upon enrolment, intuitive online patient portal solutions give patients access to their full trial journey and data, heightening collaboration as patients are provided information on trial updates, visit reminders, their disease, and more. Sponsors can also offer concierge services to guide patients through the trial process, providing a human touch to further personalise their experience and reduce burdens, including helping them navigate DCT platforms, coordinating provider visits and encouraging them to share input.

As patients want to be informed about trial outcomes and post-trial activities, maintaining a patient relationship during and after their trial journey is key for continued engagement. This connected approach empowers patients, keeping communication front and centre.

What the future holds

Looking at the future of patient centricity from an operational perspective, there are three core elements to consider:

Trial design that incorporates patient feedback and removes burdens.
Consistent and ongoing engagement with patients that emphasises the value of trial participation, allows them access to their health data and trial results, and highlights their contributions to future drug development.
Various uses of interoperable technology that connect patients to clinical care and offers other DCT solutions.

As we continue to work to integrate DCT and other solutions and better connect with sites and communities to engage patients, we left DIA thinking about how to broaden our patient centricity focus. For example, how can we integrate caregiver perspectives more meaningfully, and how can we strengthen collaborations across the global healthcare ecosystem to improve patient outcomes?

Equipped with the expertise, innovative solutions and collaborative spirit, our industry has never been better positioned to empower the patient, elevate their experience and personalise healthcare to drive better outcomes for all. We can’t wait to share additional learnings with colleagues and patients at DIA 2023.

About the Author

Dr. Cynthia Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA and chair-elect of the DIA Board of Directors.

In this role, Dr. Verst is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late phase research for IQVIA, Dr. Verst brings a holistic and comprehensive view of clinical research and champions the advanced use of real-world data, analytics, and technology to advance therapies for patients.