5 Steps to Facilitate LEP Patient Recruitment in Clinical Trials

Bridging language gaps is key to build trust and to ensure that LEP patients receive a clinical trial experience comparable to that of their native English-speaking peers.
Clinical researcher and Limited English Proficient (LEP) patient in clinical trial

Nurturing Trust to Facilitate LEP Patient Recruitment and Increase Participation

A well-designed plan can translate insights about Limited English Proficient (LEP) patient experiences and barriers to health into actionable steps. This blog breaks down the process into manageable steps to ensure you are prepared to receive and work with LEP patients effectively and, importantly, that LEP patients will have the best possible experience with your organization. Ideally, these patients may gain an increased sense of empowerment and faith in the U.S. medical system as a result.

Solving language barriers is a significant part of your plan – but not the only consideration to be addressed. LEP patients are confronted with greater sensitivities and challenges than their native English-speaking peers – deep, intergenerational trauma and medical racism. Many may be wary of lending their time and health to an experimental trial. You may have to work harder to build the same level of belief and trust in your intentions, safety protocols, informed consent, and pursuit of health equity.

What does this look like?

  • Your outreach materials must demonstrate thorough attentiveness to this language barrier and identify how you will not let it reduce their experience, interfere with their participation, or compromise their health.
  • Trial FAQs can be tailored to culturally relevant questions, concerns, and expectations.
  • Facilitating open forums with the LEP community, backed with localized collateral and native speakers in attendance to support recruitment.
  • Translated documents must be at the ready to support pre-consideration and informed consent.
  • Interpretation for live conversations is essential – and if the conversations involve highly sensitive information, in-person may be best.

Preparing for Varying Levels of English Proficiency

Be prepared to support patient diversity goals with language services for a variety of
native languages and levels of English proficiency. The HHS Language Access Plan
2023 is an excellent reference point for the requirements and expectations of advancing
equity for public health, including patients with limited English proficiency.

Speak a Language Other Than English at Home:

Central Americans: 86.2%
Cubans: 77.7%
Asian Americans: 73.5%
Hispanic Americans: 71.1%
Mexican Americans: 70.4%
Puerto Ricans: 58.9%

Not Fluent in English, Self-Reported:

Vietnamese Americans: 48.2%
Chinese Americans: 42.0%
Asian Americans: 30.9%
Hispanic Americans: 28.4%
Filipino Americans: 19.8%
Asian Indians: 17.7%

Step 1: Update Your Data Collection Processes

If you are not yet capturing patient demographic data, there is no better time than the present to begin. Consult the most recent FDA guidance on the demographic data needed, how to obtain it, and where and when you need to be submitting reports. 

If you are already capturing patient demographic data per FDA guidelines, consider alternative data categories that you have the capacity to collect. Language(s) spoken at home or self-reported English fluency would be useful categories to consider adding. Be sure you are differentiating white-identifying Hispanic populations from white non-Hispanic populations. 

Remember, it’s about making strides and demonstrating progress, not perfection.

Action Items: 

  • Analyze your data collection processes and categories.
  • Ensure alignment with FDA draft guidance regarding diversity data collection and reporting.
  • Consider expanding demographic data collection where appropriate.

Step 2: Identify Current Diversity Gaps and Establish Partnerships

These questions developed by the FDA are worth asking and engaging with sincerely:

  • Do your eligibility criteria serve the goal of having a representative sample of the population most likely to use the product?
  • Do your exclusion criteria work against these goals?
  • How can you make participation less burdensome?
  • Have you considered fostering community engagement through medical societies, focus groups, community advisory boards, disease registries, and community-based participatory research?

Check the complete trial design and conduct recommendations from the FDA to explore inclusion practices. 

Internal data may contain a wealth of untapped insights about how to move forward. Consider retroactively analyzing recent outcomes concerning racial and ethnic representation to better understand how your firm is currently performing. Can you speak with the teams in charge of recruitment, retention, and patient experience to learn about any barriers they faced when sourcing and working with patients? These insights could be among the most valuable to your implementation plan.

As you arm yourself with data and gather the right questions to ask, the natural next step is to start forming partnerships within your organization. You can expect a smoother, more comprehensive implementation by ensuring each department has a stake in your inclusion goals. Some approach it top-down, starting with a companywide, strategic-level commitment to inclusion. Others begin with grassroots, multi-disciplinary committees to build the resources and relationships necessary to pursue inclusion as a company practice. Either way, ensuring widespread buy-in will be foundational.

Action Items:

  • Using available data, identify diversity gaps within your current and future trials.
  • Build partnerships across your organization to establish shared diversity and inclusion goals.
  • Identify languages needed for future language services support.
  • Develop benchmarks for future trials.

Step 3: Develop a Multilingual Clinical Trial Outreach Plan

Your outreach plan represents a starting point for establishing trust and credibility with LEP candidates. Per HHS and FDA rules, ensure your patient recruitment strategy is language-accessible. Translations should align with cultural sensitivities regarding doctor-patient interactions, expectations for privacy, and assurances to the level of care they can expect.

Action Items:

  • Translate outreach materials into target languages with consideration for varying cultural context(s). 
    • These include websites, landing pages, pamphlets, videos, emails, letters, downloadable PDFs, social media posts, and other informative or marketing content.

Step 4: Translate Informed Consent Materials

The informed consent process ensures that a clinical trial’s purpose, procedures, potential benefits, and potential risks are completely understood. Two forms of language services must be available to enable informed consent for LEP patients: written translations (developed in advance) and live interpretations for intake, doctor-patient interactions, and other conversation-based communications.

Your Language Access Plan should identify which resources are available to patients and the circumstances in which they are available.

Action Items [Translation]: 

  • Patient Reported Outcomes (PROs)
  • Scales and Quality of Life (QoL) Instruments
  • Summaries of Product Characteristics (SmPC)
  • Adverse and Severe Adverse Events
  • Patient Recruitment, Questionnaires, Quality of Life Scales, Diaries and Interpretations
  • Patient and Clinician Education Materials
  • Patient Informed Consent Forms (ICFs) and Patient Information Leaflets (PILs)
  • Patient Diaries/Forms/Materials
  • Clinical Study Report Forms and Clinical Study Protocols
  • Clinical Trial Recruitment and Retention
  • Case Study Report Forms (CRFs)
  • Investigator Brochures
  • Physician Letters
  • Site Documentation and Reports
  • Packaging and Labeling
  • Import/Export Permits
  • Preclinical – Phase IV Documentation

Action Items [Interpretation]: 

  • Identify clinical trial milestones for in-person, video, and/or phone interpretation.
  • Ensure a language services team is contracted for the duration of the clinical trial.
  • Source the technology/tablets needed for virtual interpretation.

Step 5: Deliver a Superior Clinical Trial Experience to LEP Patients

Smooth execution and consistency are critical to ensure LEP patients receive a clinical trial experience comparable to their peers. This means working with a professional language services provider (LSP) with a pool of certified linguists. Ideally, the pool will include medical board-certified interpreters and translators – they have the linguistic skill set and they live and breathe medical research and treatment – rendering superior results that build patient trust.

A seamless experience requires frequent, up-front communication about LEP patient expectations and resources. Ensure tablets are charged and ready for video interpretation during in-person visits. Plan for on-site resources for sensitive conversations. Make it a point to request and analyze LEP patient feedback, comparing it to English-fluent patients to understand the effectiveness of your plan’s implementation.

Action Items: 

  • Select a language services partner that can deliver quality-assured translation and interpretation from a qualified pool of linguists.
  • Collect and analyze LEP patient feedback.

Gain Patient Trust and Accelerate Development with a Language Service Partner

A core tenet of your plan must include partners with specialized capabilities to help you carry ideals into action. As the go-to language service provider for life sciences firms looking to implement a race and ethnicity diversity plan, PGLS brings clinical trial expertise to deliver an excellent experience to LEP patients – from the earliest awareness and consideration stages through ongoing trial management and reporting.

Dedicated to navigating the ins and outs of FDA and HIPAA requirements, our highly qualified linguist pool can facilitate highly sensitive patient interactions with accuracy and empathy. Our trusted in-country linguists, subject-matter experts, board-certified medical doctors, and sophisticated translation software bridge language and culture for compassionate and effective communication. Comprehensive project management delivers successful outcomes, protects sensitive medical data, and delivers a consistent patient experience from start to finish. Get in touch to learn more.