Patient engagement efforts typically yield financial benefits many times larger than the original investment, while patient recruitment accounts for up to 30% of development timelines, with an estimated $1.2 billion spent on this activity. Substantial numbers of patients – sometimes 30% or more – drop out of clinical trials, an estimated 46% of trials fail due to poor patient recruitment, and nearly all trials require timeline extensions due to recruitment issues.
Against this backdrop, the need for a strategic approach to engagement, recruitment and retention is clear. For trials to proceed according to plan, meet milestones and produce optimal results, it is vital that the research sites conducting the study and the participating patients remain closely involved and engaged throughout the study lifecycle from startup to conclusion. A well-planned patient recruitment and retention strategy is the most reliable route to success – and yet often this is put into place as an afterthought, rather than as an explicit part of the protocol and strategic study planning. Reasons may include an unwillingness to commit budget to specific patient- and site-centric activities, but this approach can be short-sighted, since later efforts required to rescue a trial that is not recruiting as planned typically incur further costs as a result of trial delays.
Another element to keep in mind is that estimated recruitment and retention rates are often based on available data from earlier studies, from industry databases, could be misleading. Such data does not always tell the full story, typically lacking details of how these historical trials were actually operationalized – for example, there may be no information on the recruitment strategies and tactics used, the success of their implementation, levels of site staffing at study launch, or awareness of key opinion leaders, patient advocacy groups and the patient community at large of the study drug and associated clinical research. Despite these shortcomings, this historical data is used as the foundation of major study-related decisions, such as the number and geographic distribution of study sites required to meet target enrollment rates. There is certainly room for improvement to ensure that recruitment targets for the new study are readily achieved.
Implementing strategic best practices
Sponsors wishing to implement best practices in identifying, attracting and recruiting qualified patients for their studies should consider working with a partner who integrates early feasibility with patient journey mapping and recruitment planning to ensure a comprehensive approach is applied for strategic planning.
To effectively foster patient engagement and ensure patient retention in a trial, sponsors should consider incorporating the following eight steps in their strategy planning cycles:
- Understanding patient and caregiver profiles, by researching the likely patient and caregiver profiles using epidemiological information and social listening. It is important to take the time needed to accurately identify their trusted sources of information. A high-level DE&I assessment of sites should be conducted through ethnic heatmaps, which can be overlaid with site locations, or by seeking out diversity information from sites.
- Recognizing key differences between various diseases and patient populations, which should be reflected in the use of multiple channels to support strong recruitment tactics based on preferences and requirements. Reviewing the indication landscape in terms of competition from other clinical research studies also provides important information for overall study planning and site selection.
- Mapping out the patient journey leading up to diagnosis, receiving diagnosis and treatment(s), highlighting potential challenges and support needs, and designing strategies to address these where possible. Understanding where in the journey the patient might be and recognizing the sign-posting entry points for clinical research studies.
- Minimizing patient and site burden by analyzing the study protocol and identifying opportunities to lessen burdens as far as possible using decentralized clinical trial elements and other patient and site-centric approaches. Examples include the option for patients to replace one or more site visits with a home nursing or telehealth visit, or providing the services of a travel concierge to make essential site visits less burdensome. It is also vital to understand that the patient may have work and/or childcare responsibilities and to reimburse them for time off work or providing hotel access close by if they are a long distance from the site. Another useful approach is to assess the time required on-site by the patient during a visit and how that could be made more comfortable by providing sites with child-friendly activity kits, books or puzzles, and magazines or perhaps blankets for adolescents and adults. The burden is not always physical. Understanding and recognizing the social and emotional burdens placed on people, and lessening these, is important too.
- Working with specialists in the disease area, such as patient advocacy groups, to build engagement tactics around the patient profiles, and proactively seeking out patient/caregiver insights from sources including focus groups, targeted social listening and health crowdsourcing companies. Specialist recruitment vendors can also be useful, especially ones that take a ‘one-to-many’ approach to recruitment campaigns, leveraging services from multiple partners within their own networks. Other specialist vendors specifically target a therapeutic area and are well known and trusted sources for patients to seek out information about clinical research. Selecting the best possible partner in a particular space can be key to success.
- Developing creative materials to support recruitment and retention, including clinical trial materials, planning and placement of advertisements, and development of patient-facing websites and apps. It can be helpful to work with partners that understand patient and caregiver profiles and journeys to create materials based on messages that resonate successfully with the intended audiences. These materials should reflect diversity and account for any local culture and patient health literacy differences. It is important to tailor materials to reflect the fact that the environment and timeframes for decision making can be very different, for example, for a patient in the ICU, compared with one with a long-standing rare disease.
- Making appropriate site feasibility assessments at the strategic level before continuing to trial site identification and site selection, with feasibility teams liaising closely with patient engagement experts to ensure inclusion of all perspectives. The right questions about patient preferences and engagement tactics should be included in feasibility assessments. In some cases, operational teams can also tailor plans to include patient engagement tactics or suites of tactics that will work for an individual site.
- Gaining site and patient/caregiver level feedback on recruitment strategies and determining viewpoints of investigators, study coordinators and other site staff on their support needs for the study. These can vary widely by institution or geographic region. Site and patient perspectives can also differ, so this step is important in finding a middle ground for strategies to satisfy all stakeholders while maintaining scientific integrity.
Study recruitment and retention targets are within reach with thoughtful implementation of these eight strategies. These can be applied to avoid study pitfalls; underpin successful participant identification, recruitment, and retention; optimize patient and caregiver experiences; and support budget discussions to ensure adequate funding for these vital elements in strategic study planning.