Design, Biostatistics, and Clinical Research Ethics

1
Design, Biostatistics, and Clinical Research
Ethics

• Doris M. Rubio, PhD
• Core Director
• Associate Professor of Medicine
• University of Pittsburgh

2
Specific Aims

• Provide centralized services to trainees,
  fellows, and junior faculty who are conducting
  Clinical and Translational research and educate
  them about these services
• Organize research entities into a network to pair
  investigators with specialized services

3
Specific Aims

• Conduct research on cutting-edge methodologies
• Organize seminars to bring together the network
  and develop ways to translate new tools and
  methodologies into research

4
Services for Design, Biostatisics and Data
Management
Core Director
Trainees, Fellows, Junior Investigators
Funded Investigators
1
2
Online Research Community Web based database of
Entities
DBE Core Design, Biostatistics, Clinical
Research Ethics
Liaisons
Entities and Core coordinate novel research
and training
Entities Centers Institutes Departments
3
4
5
DBE Core

• Consultants
• Biostatistician, Epidemiologist, Methodologists
• Ethicist (including the Center for Bioethics and
  Health Law)
• GSRs from Biostatistics to work with
  Epidemiologist and Biostatistician
• Office of Clinical Research has an
  epidemiologist and statistician
• Collaborating with the consulting services in
  Biostatistics and Statistics Departments

6
DBE Core

• Examples of Services
• Proposal review
• Grant development Power analysis
• Design consultation (RCT, observational studies,
  case-control, large databases, health services,
  qualitative methods)
• Statistical consultation
• Recruitment consultation
• Psychometric consultation
• Ethical consultation

7
Services for Design, Biostatistics and Data
Management
Core Director
Trainees, Fellows, Junior Investigators
Funded Investigators
1
2
Online Research Community Web based database of
Entities
DBE Core Design, Biostatistics, Clinical
Research Ethics
Liaisons
Entities and Core coordinate novel research
and training
Entities Centers Institutes Departments
3
4
8
Entities

• Pitt, UPMC, RAND, VA, etc. have a multitude of
  resources in regards to design and biostatistics
• Mobilize resources to match investigator with
  most suitable entity
• Investigator or DBE core searches database to
  find the appropriate liaison
• Liaisons serve as the link between the
  investigator and the entity

9
Services for Design, Biostatisics and Data
Management
Core Director
Trainees, Fellows, Junior Investigators
Funded Investigators
1
2
Online Research Community Web based database of
Entities
DBE Core Design, Biostatistics, Clinical
Research Ethics
Liaisons
Entities and Core coordinate novel research
and training
Entities Centers Institutes Departments
3
4
10
Novel research

• Support novel research on new methodology,
  statistical approach, or ethical issues
• Disseminate that information through seminars and
  publications
• Consult with investigators to implement
  methodology into research practice
• Funding 2 pilot proposals

11
Training

• Collaborate with education core to provide
  seminars for junior investigators
• Collaborate with existing seminars in statistics
  and epidemiology
• Annual featured guest speaker on research
  methodology, epidemiology, or statistics
• Bruce Turnbull from Cornell (adaptive designs)
• Collaborate with T32s to provide experiential
  training

12
Summary

• Core Services
• Design and Biostatistics
• Ethics
• Networking of entities
• Novel and innovative pilot research
• Training

13
Design, Biostatistics, and Clinical Research
Ethics

• Doris M. Rubio, PhD
• Core Director
• Associate Professor of Medicine
• University of Pittsburgh