Integrating the patient perspective for effective trial design and engagement customisation

Industry stakeholders have moved beyond considering patients as clinical trial “subjects”, and instead recognise the tremendous value of viewing those most impacted by a disease as partners in drug development. To better engage patients in trials, it is vital to weave their perspectives into trial design and give them a more meaningful and less burdensome experience, while still improving research outcomes and making sure sites are not loaded with added tasks. 

Designing trial protocols that consider patients’ real-world experiences and influences for participation is important if we are to create the environment needed to pique and keep their interest. These experiences and influences vary per patient population and sub-populations. Factors such as age, location, race and ethnicity, socioeconomic status, and therapeutic needs play a role. It is through such nuances that sponsors can identify target populations and what elements to factor into design to improve engagement. Below, we discuss how integrating patient perspectives and considerations according to therapeutic areas, such as migraine, hypertension, and respiratory syncytial virus, provides deeper insights that can be plugged into customised approaches to patient-centred design. 

Gathering patient perspectives: First and foremost 

To understand patients’ needs, one of the first steps in the planning process is to approach the source, including patients, caregivers, and providers, in order to actively listen and digest feedback in a thoughtful way to gauge the target patient profile and improve trial design accordingly. In some cases, this may involve surveying patient groups found in proprietary databases, company-specific patient communities and registries, patient or disease advocacy groups, and online databases. Focused survey questions that help secure insights about potential areas of patient burden and specific experiences with the disease and gauge patients’ willingness to participate in a trial with certain protocol elements can help sponsors learn more about the target patient profile for the evaluated therapeutic area and how best to engage them. 

Through survey insights, sponsors may learn why it can be difficult to find and engage the ideal patient population for a particular trial based on protocol elements not matching well with their needs or experiences. This includes individuals’ sensitivities to information they may not want to provide in a survey, such as number of sexual partners or race, and issues with study design, such as if the number of site visits is burdensome or they require invasive procedures. For example, if among 200 potential patients with hypertension or related risk factors only five pass participation screening, clinical research organisation partners and study teams can set realistic expectations for the sponsor about how difficult recruitment may be with the current trial design. 

Though sponsors will not always be able to completely revamp the protocol, these insights can help determine how to better support patients and potentially sites through what may be difficult recruitment and engagement. 

Results of surveys and interviews with principal investigators can be added to other deidentified patient data, such as demographics, lifestyle, and clinical experience with the disease, to identify the optimal outreach approaches for these populations with consideration for effectiveness and empathy. 

Empathy-driven creatives 

Once stakeholders understand the target patient population for the trial, their feelings about their healthcare journey and related quality of life and what they may need to participate, these insights can be leveraged to customise the creative development process to reach individuals of interest and ensure they are engaged through trial completion and even after. 

Expert writers on the study team can help ensure recruitment includes messaging that resonates with patients. For example, in a trial specific to hypertension, market research and patient insights showed the target patient profile would be men aged 40-50 in middle-to-senior positions in their careers and likely to have younger children. These insights indicated the patients to approach might not focus on a healthy diet or exercise routine due to professional and family responsibilities, and may not take significant steps to treat their high blood pressure. 

As such, the creative messaging used for recruitment emphasised how, for those with a busy daily routine, hypertension may not seem like a serious concern, but it is nevertheless necessary to take action to ensure their health. Through this message directed at the target patient group in a multi-channel outreach programme (e.g., digital and social media platforms, direct email activities, and proprietary marketing network with specialised provider partners), the sponsor was able to exceed the patient enrolment goal in the trial. 

As another example, when setting up for a migraine study, using descriptors patients shared when recalling what their migraines feel like, such as “dark” and “thunderous”, the creative team developed a video for approaching this group. This video aimed to relate to patients’ pain by starting with dark imagery that transitioned to a lighter and positive visual as the narration explained the study and how it may help advance research for individuals suffering from debilitating migraines. 

As patients express interest and are onboarded into trials, it is vital to keep a consistent eye on evolving needs for the patient and sites and determine what communications and how often to be in touch with them would help ensure retention and engagement. 

Enabling patient (and site) support through digitised solutions

From trial recruitment through post-completion, adequate support for patients and site teams alike will be crucial. But again, the solutions and services that will help optimise engagement can vary per trial and related patient population. 

To ensure patients have a streamlined process through recruitment, screening, and enrolment, it is vital to help sites reach participants in a timely and efficient way. Comprehensive platforms that sites can access to manage patient referrals for trials can be beneficial for effective recruitment and engagement. Through a one-stop shopping approach, referral platforms become a landing spot for referrals from any source (e.g., referring physicians, third-party health partners, direct-to-patient outreach campaigns, site databases, etc.) to allow sites to efficiently perform onboarding tasks in real-time for multiple participants and help streamline and speed up pre-screening and enrolment. For the hypertension and migraine studies, pre-qualified referrals driven into a comprehensive platform for engaged sites helped to provide support for these teams and improve patient engagement. 

Regardless of whether a trial is decentralised or site-based, this type of digitised solution allows sites to conduct pre-screening, consenting, and screening activities with participants remotely, using integrated telehealth technology, and reduce logistical burdens of travelling to sites for in-person visits. These platforms can also be designed to seamlessly integrate other beneficial capabilities, such as electronic medical records retrieval and electronic consent. 

To help optimise site performance and ensure patient onboarding goes smoothly, it is key to remember the human elements of support that can be integrated into design, too. For example, in the migraine study, experienced research assistants were placed at sites to help with pre-screening and data entry during enrolment. Through this added support and engaged site teams, 46% of participant referrals were successfully contacted. 

Continuous banking and sharing of insights 

Patients in trials want to know about their progress, and in many cases, how their participation moved research forward for others in need. They are playing an active role in managing their own healthcare and deserve to have input into critical research that ultimately impacts them. 

Continuously gathering their insights during and after the trial can help with adjusting information or support needed for the trial at hand and shape design and engagement strategies for future programmes. In turn, keeping patients in the know and regularly sharing information with them, such as disease-related reports, are tangible ways to optimise their experience and ensure they are seen as valued partners in the process.

About the authors

Jill Guary is patient centricity data manager in the experience optimisation team at IQVIA. She is a global clinical research professional with more than 20 years’ experience in the pharmaceutical, academic, and market research industries. Guary began her career as a study coordinator in academia, before transitioning to the public sector, taking leadership roles in life sciences market research and clinical research organisations.

Jessica Jones is director of strategic technology delivery – experience optimisation at IQVIA. She is a solutions-oriented innovator with more than 17 years of combined experience in clinical research and technology development and delivery across pharmaceutical, public health, and academia research sectors. Jones leads a team of innovators focused on delivering custom tech-enabled strategies to help drive successful patient recruitment, engagement, and retention outcomes.

Gail Long is director and head of marketing patient recruitment and enablement at IQVIA. She brings more than 10 years of experience in patient recruitment and three decades of marketing experience to her current role, in which she is responsible for connecting potential patients to clinical trials and ensuring her team effectively incorporates their needs into all aspects of marketing outreach.