Measurement and Regulatory Science (MaRS) Fellowship Program

Research Pioneers

Incorporating the patient voice in heaIth interventions is becoming increasingly criticaI to healthcare advancements. However, to do this accurately and effectively, we need more skilled researchers who understand the technical and regulatory aspects of clinical outcomes assessments and how to evaluate health interventions based on patient values.

Beginning fall 2021, Duke's Measurement and Regulatory Science (MaRS) Fellowship Program will shape early career investigators in these particular areas. 

Throughout this two-year program, fellows will focus on both didactic training and real-world regulatory issues related to patient-centered research. Therefore, each participant will receive:

  • One-on-one training by internationally recognized Duke faculty with expertise in patient-reported outcomes methodology, patient preference assessment, regulatory science, and/or stakeholder engagement
  • Mentor-guided work opportunities in industry or with regulatory agencies
  • A tailored program specifically for the fellow, ensuring he or she completes the program with a core set of competencies

 

"There has been a major shift over the past decade toward patient-centered research. Our fellowship program provides training on the methods for capturing and including the patients' voices in the evaluation of safety and efficacy of interventions under study."

 —Bryce Reeve, PhD, Director, Center for Health Measurement

 

 


MaRS Fellowship Core Skillset

  • Designing, selecting or evaluating clinical outcomes assessments (COAs)
    • Best practices for survey design
    • Measurement theory and models
    • Qualitative methods for concept elicitation
    • Qualitative methods for cognitive testing
    • Quantitative methods for evaluating psychometric properties of COAs
       
  • Integrating COAs in clinical trials
    • Endpoint positioning of COAs
    • Analytic considerations for COA endpoints
       
  • Survey methods for valuing outcomes and assessing preferences
    • Random-utility theory and models
    • Economic models for choice under uncertainty
    • The use of preference data for patient-centric benefit-risk analysis
       
  • Patient-focused drug and device development
    • Engagement of stakeholders throughout development programs
      • Best practices for patient engagement
    • Conceptual models relevant to a development program (e.g., of disease, endpoint model, context of use)



"We recognize that each fellow comes to the program with unique experience and training. Rather than requiring a standard curriculum, we customize the coursework and mentoring to meet each individual's goals." 

— Kevin Weinfurt, PhD, Co-Director, Center for Health Measurement


 


Our Approach

Recommended as an 80/20 program, MaRS will provide early career investigators training and experience with clinicaI outcomes assessments and patient-centered research opportunities to prepare them for their next career in industry or with regulatory agencies. See below for information regarding each year of the program. 

YEAR I 

Location: The Center for Health Measurement within the Department of Population Health Sciences at Duke University School of Medicine in Durham, N.C. 
Focus: Strengthening skills via didactic training and participation in ongoing studies involving COAs

During this time, fellows will attend graduate-level courses offered through: 

  • Duke's Clinical Research Training Program

  • The Department of Population Health Science's graduate program

  • Ad hoc courses offered throughout Duke

  • Independent studies with program faculty

YEAR II 

Location: Regulatory agencies or industry 
Focus: Real-world, experiential patient-centered research

Fellows will also conduct a mentored project that is both related to patient-centered research and can contribute to regulatory decision making and policy making. 

Eligibility

Applicants should have a doctoral degree in public health, psychometrics, education measurement, biostatistics, medical sociology/anthropology, nursing, medicine, or related fields. Candidates would also need to move to the Durham, N.C. area for the first year of the program. 

Important Dates

Application Period Start: October 1, 2020
Application Due: December 20, 2020
Decision: March 31, 2021
Fellowship Start: Fall 2021

Please contact Mary Trabert for more information.