The pharmaceutical industry faces significant challenges in clinical trial recruitment and retention—often struggling with timelines, cost overruns, and limited access to representative patient populations. Why? In part, the status quo typically focuses on study-specific community engagement, a reactive approach usually implemented shortly before or during the recruitment phase.
While sometimes necessary, this method is inefficient and misses substantial benefits achieved with a proactive, sustained approach at the therapeutic area (TA) level. It is also ineffective for building long-term relationships and “affective trust” with key communities who are underrepresented in clinical research.
The following argues for a strategic shift toward sustained community engagement at the TA level, highlighting its potential to: improve return on investment (ROI), reduce costs, enhance clinical trial outcomes, impact patient retention, and help sponsors leverage community investments made at the trial stage throughout the therapeutic lifecycle.
The Limitations of Study-Specific Community Engagement
The conventional study-specific community engagement model treats potential participant outreach as a tactical, short-term endeavor tied to individual trials. Sponsors allocate budgets on a per-study basis, leading to fragmented efforts and a lack of continuity. This approach often results in:
- Delayed recruitment: Initiating community engagement late in the process compresses timelines, leading to rushed efforts and potentially missed recruitment targets.
- Limited reach: Study-specific campaigns often fail to reach beyond immediate recruitment needs, missing opportunities to cultivate long-term relationships with potential participants.
- Missed opportunities for data collection: Valuable insights into community needs, preferences, and barriers to participation are lost due to the episodic nature of study-specific engagement.
- Suboptimal retention strategies: Without ongoing engagement, understanding the root causes of patient dropout becomes difficult, hindering the development of effective retention strategies.
The Power of Sustained, Therapeutic Area Community Engagement
A strategic shift toward sustained community engagement at the TA level offers a compelling alternative. It involves building ongoing relationships with patient communities, advocacy groups, and key opinion leaders within a specific therapeutic area. Instead of maintaining episodic outreach, engagement becomes a continuous process of education, trust-building, and empowerment.
Hypothetical TA-Level Model
Consider a scenario at Sponsor X involving a portfolio of lung cancer trials. Instead of performing 10 separate studies, each conducting its own limited outreach, the research entity establishes a sustained therapeutic area community engagement program. Here’s how it might play out:
- Shared cost model: Each study contributes a fraction of its budget to a shared pool, creating a total investment for sustained community engagement centered on lung cancer.
- Continuous engagement: This collaborative investment supports ongoing activities such as informational workshops, community health fairs, and online forums, fostering a vibrant lung cancer community. Activities focus on general lung cancer education, awareness of research opportunities, and building relationships with potential participants. They do not involve soliciting personal health information or study-specific details and therefore do not require IRB review.
- Accelerated recruitment: When a new trial opens, a pre-engaged pool of potential participants is already available. Even a modest conversion rate can accelerate recruitment timelines dramatically—potentially reducing them from years to months.
- Cost savings & mobilization: While an additional cost emerges to mobilize this pre-engaged pool for a specific study, the accelerated recruitment and reduced need for intensive advertising can lead to significant budgetary savings. Per-study expenditure accounts for activities required to transition individuals from general therapeutic area engagement to study-specific participation. This mobilization phase, involving activities like pre-screening, informed consent discussions, and collection of eligibility information for a specific trial, would require IRB approval. Considering the average cost of recruiting a single patient, even a small improvement in recruitment efficiency can translate to substantial financial benefits.
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Improved Patient Retention Through Sustained Community Engagement at the TA Level
Critically, sustained therapeutic area community engagement—because it is not tied to a specific study start or stop—allows for continuous data collection and relationship-building that directly impacts patient retention. By leveraging trust built within the community and gathered data insights, pharmaceutical companies can proactively address common reasons for patient dropout, such as:
- Lack of understanding about the study: Ongoing education and communication within the community can ensure participants are well-informed and engaged throughout the trial.
- Concerns about side effects: Open communication and support resources can help alleviate patient anxieties and improve adherence.
- Logistical challenges: Understanding the specific needs of a community can help tailor support services and minimize barriers to participation.
Addressing these issues through sustained community engagement can improve patient retention rates significantly, leading to substantial cost savings by reducing the need for additional recruitment due to dropout and ensuring the integrity of study data. Keeping participants engaged further strengthens the ROI of sustained community engagement at the TA level. Additionally, community insights that are gathered sustainably at the TA level may be valuable to several functional teams (i.e., Clinical Operations, Marketing, Medical Affairs, Patient Advocacy) across the treatment development lifecycle.
Key Benefits of Sustained Engagement at the TA Level:
- Improved ROI: Accelerated recruitment, reduced advertising costs, and improved patient retention contribute to a stronger return on investment for clinical trials.
- Enhanced representation and inclusion: Sustained community engagement fosters trust within underrepresented communities, helping address key barriers to participation and promoting more representative trial populations. A TA-level approach addresses the two primary reasons for lack of participation among underrepresented groups: not being asked and mistrust.
- Data-driven insights: Continuous engagement allows for the collection of valuable community insights, informing protocol design, site selection, recruitment messaging, and patient retention strategies. This sustained community engagement model becomes a valuable asset for subsequent trials and several different teams within the pharmaceutical company.
- Strengthened reputation: Demonstrating a long-term commitment to patient communities enhances sponsor reputation, building trust and fostering stronger relationships with key stakeholders across care.
- Long-term value: The benefits of a sustained and engaged community extend beyond individual trials to create a foundation for upcoming marketing in addition to research and development efforts. TA-level strategies enable pharmaceutical companies to leverage community investments made at the time of the trial throughout the development lifecycle.
Embracing a Strategic Imperative for More Comprehensive Trials
Shifting from study-specific to therapeutic area community engagement represents a strategic imperative for pharmaceutical companies as they seek to optimize clinical trial recruitment and maximize participation. By embracing a proactive, long-term approach, sponsors can unlock significant benefits, including improved ROI, enhanced representation, valuable data insights, a stronger reputation, and more importantly, improved patient retention and cost savings.
This paradigm shift requires a change in mindset, with TA leads taking ownership of sustained community engagement and allocating dedicated resources. The transition may require an upfront investment, but the long-term returns, both financial and societal, will far outweigh initial costs. The future of clinical trial recruitment lies in building “affective trust” and lasting relationships with the communities we serve.
Want to know how a TA-level approach would work for your clinical research? Schedule a meeting with our team.