Regulatory Science Symposium: “Keys to a Clinical Trial: Management and Operations” Session 4 - Clinical Trial Communications for Diverse Populations (2024)

Competencies: Ethical Considerations, Health communications, Diversity, Clinical Trials, Plain Language, Clinical Research, Regulatory Science, Regulatory and Quality Sciences

Course Syllabus/Topics:

1. Contents
2. Defining and Understanding Diversity
1. What is diversity? Includes elements such as Socio-economic status, age, culture, access to insurance and care, education levels, geographical locations, gender identity, race, ethnicity, stigma, and social and environmental determinants of health – all of which are tied to healthcare access.
2. Why is diversity important? Not only to be mindful of lived experiences, but also has implications for how diseases are experienced or treated.
3. History Lesson
1. History of Clinical Trial Participation
1. NIH ensures that women and minorities are included in all clinical research. Became the law in 1993 to include women and underrepresented ethnic and racial groups in clinical translational research.
2. Trials should be carried out so that it is possible to study whether variables affect these populations differently than other participants.
3. Cost is not an acceptable reason for excluding women and minorities.
4. NIH initiates programs and support for outreach to recruit and retain them as volunteers in clinical studies.
2. What about now?
1. Majority are not told about opportunities to participate in research.
1. Only about 5% of Americans have ever participated in a clinical trial. About 87% of Americans feel that healthcare professionals should discuss CTs with patients diagnosed with a disease.
2. Biden Cancer Moonshot Initiative – seeing diverse participation in clinical trials, diverse clinical trial workforce, and community engagement.
4. Human-centered approach
1. “Seek first to understand, then to be understood.”
2. Planning process is participatory and co-created.
3. Important to infuse formative and summative evaluation.
1. Formative: Focus groups, interviews
2. Summative:
4. Some element of qualitative work.
5. Ethical role of researchers
1. Communicate regularly and compassionately with participants
2. Clinical trial participation is voluntary – altruism
6. Communication strategies
1. Multi-pronged and multi-layered approach
2. Written materials: Pre-test with community, availability of materials in different languages
3. Communication preferences – frequency of communication, availability, perceived barriers
4. Workforce - Staff trained in cultural sensitivity
5. Return of Results – Regularly and understandable
7. Course corrections
1. Check progress regularly
2. Be flexible
8. Case Scenarios
1. Strategies to mitigate situations
2. Use of introductory videos, virtual tours of laboratory
9. Q&A
   

Acknowledgements
Accompanying text created by:
Roxy Terteryan, Project Administrator, SC CTSI (atertery@usc.edu)
Rushaanaaz Sokeechand, Student Worker