Table 2.
Community Consultant Panel (CCP) recommendations for improved participation in clinical trials and modifications made by investigators
| Domains of discussions from Community Panel | Specific trial modifications developed in collaboration with the CCP, including implemented strategies and recommendations that could not be implemented (denoted with a ) |
|---|---|
| Increase trust in the research process | |
| Enhance transparency | • Indicate source(s) of trial funding (private vs. public/NIH) and of decision-making power for discussed modifications, i.e. local vs. national vs. pharmaceutical companies • Transparent trial-relevant information readily available to public in lay language (COVID-19, vaccine trial processes, vaccine types and status) • Trial participation expectations and procedures (time in participation, compensation, risks, and benefits) |
| Need for trusted messages with accurate information | • Identify trusted community venues, media, and leaders for outreach about COVID-19, clinical trials, and vaccines • Support messengers with clear information and sources about COVID-19, vaccine trial processes, and vaccine types |
| Community engagement and recruitment strategies | |
| Engagement and outreach | • Multiethnic media and venues for trusted communication • Approaches (face-to-face, virtual, written, flyers, social media) • Community-identified venues and leaders to share clinical trial opportunities and provide informational sessions • Appropriate language and messaging based on race/ethnicity, literacy-level, translation, or cultural context for outreach |
| Suggestions for local clinical trial recruitment website | • Customize website for usability, accessibility, readability, inclusive language, benefits of inclusion, and common community questions • Increase diversity and representation of minority groups in website images • Improved FAQ questions section addressing participant expectations in clinical trials |
| Suggestions for outreach materials (flyer) for clinical trials | • Create a Spanish version of the trial outreach flyer, an additional Spanish-language recruitment website, screening, and consent materials • Tailor language on materials (increase font for readability, remove scientific jargon, and use appropriate reading level) • Use inclusive wording (i.e., instead of, “help us find a COVID-19 vaccine,” use, “Let’s find a COVID-19 vaccine together” • Remove language on “documentation of negative COVID19 test” to reduce the opportunity of potential confusion for undocumented participants • Add complete contact information for questions and inquiries (phone, website, email, and language translation services) rather than only the website to sign-up • Use images reflecting a diverse population |
| Address emergent issues and misinformation around COVID-19 vaccine trials | • Participate in community discussions to update community members and to help address mis- and dis-information identified by CCP and their networks |
| Enhance trial accessibility and acceptiblity | |
| Provide transportation for participants | • Provide transportation for routine visits and COVID-19 positive “sick day visits” |
| Provide a welcoming environment and “customer service” at clinical trials sites | • Provide descriptions of what to expect when arriving at the sites, language concordant greetings and introductions, familiarization or tour of location (where to find restrooms, waiting areas, etc.), and genuine appreciation of trial participation • Provision of snack bags/water bottles upon entrance or exit • Obtain patient preferences (pronouns, name, language) • Adjust/reduce waiting times for participants • Include diverse staff members to great participants and language concordant staff (and for phone calls) • Include child/elder care during visits a • Provide other health services at the clinical trial sites a • Clear explanations and communication of eligibility and ineligibility |
| Locate trial sites in minority communities | • Recommended additional trial sites in neighborhoods with high COVID-19 risk and outcomes a |
| Access to health care for uninsured participants if adverse reactions/COVID related illnesses | • Emphasize that participants receive health coverage for study-related injuries and adverse reactions through the National Vaccine Injury Compensation Program • Health coverage for COVID-19 clinical care is not included a • Referral protocols for uninsured or underinsured persons to obtain needed COVID-19 or other clinical care |
a
Recommendations the Los Angeles COVID-19 trial teams were unable to implement (see narrative for additional detail).