The BASE Lab team of faculty experts, interviewers, and analysts partners with clinical investigators and sponsoring organizations throughout the lifespan of a study from grant proposal to written findings, offering methodological expertise, operational capacity, and training.
Developing an Evaluation Framework for NIH’s Single IRB Policy
BASE Lab faculty and staff serve as the Social Science Team for the Clinical Trials Transformation Initiative (CTTI). In this capacity, faculty collaborates with a multi-stakeholder CTTI project team and the National Institutes of Health (NIH) to design and conduct qualitative research to gather key stakeholders’ experiences with implementing the single IRB (sIRB) process. Data inform the development of a framework to evaluate the implementation of the new NIH sIRB policy.
A faculty member contributes to developing the grant proposal, leads study protocol and question guide development and writes up the study findings. Interviewers and analysts conduct the in-depth interviews with key stakeholders and thematically analyze the data.
Adolescent HIV Vaccine Clinical Trial Acceptability and Feasibility in North Carolina
The BASE Lab is partnering with principal investigator Amelia Thompson, MD, MPH, Assistant Professor of Pediatrics and member of the Duke Human Vaccine Institute, to identify the acceptability of and barriers and facilitators to adolescent participation in HIV vaccine clinical trials. Interviews are conducted with cisgender and transgender adolescents, and with parents/caregivers of cisgender and transgender adolescents.
A BASE Lab faculty member provides mentorship in developing the grant proposal, study protocol, and question guides, and in writing the study findings. Interviewers and analysts conduct in-depth interviews with adolescents and caregivers, lead the thematic data analysis, and provide tailored training for Dr. Thompson’s team to build capacity in qualitative interviewing and thematic analysis of interview data.
IMMUNOLOGY & NEUROLOGY
Quality of Life and Medical Information Needs and Comprehension of Patients with Psoriasis and with Systemic Lupus Erythematosus
The BASE Lab is partnering with UCB Pharmaceuticals, a global immunology and neurology biopharma company, to conduct a mixed-methods study to identify, describe, and quantify quality of life experiences and medical information needs among patients with either psoriasis or systemic lupus erythematosus.
A BASE Lab faculty member developed the grant proposal and study protocol and write the study findings. Along with the project leader, they also develop question guides and surveys. Interviewers screen potential participants and conduct in-depth interviews and surveys; analysts thematically analyze the qualitative data and use descriptive statistics and tests of association to describe the survey data.
RETURN OF RESULTS
Gathering Evidence to Develop and Assess Caregiver and Participant Communications
The BASE Lab is partnering with the Pediatric Trial Network (PTN) and Duke Clinical Research Institute’s communications team to conduct interviews with caregivers and adolescent participants to:
- Assess the attractiveness, comprehension, relevance, acceptability, persuasiveness, and credibility of draft PTN thank you notes and lay summaries of study results
- Identify engagement preferences during and after PTN studies, and expected feelings and responses to receiving thank you notes and lay summaries of study results
A faculty member leads study protocol and question guide development and writes the study findings. The BASE Lab project leader, interviewers, and analysts identify and recruit PTN trial participants and caregivers with partner PTN sites, conduct in-depth interviews, and analyze data thematically.