1. Guidelines for Conducting
Clinical Research
Using Retrospective Data

2. What is a Retrospective
Clinical Study?
• Retrospective studies are observational
– They “look back” at data recorded for
purposes other than current research
• Examples: Medical records and claims data
– No protocol interventions regarding
observations and measurements

3. Advantages of
Retrospective Clinical Studies
• Require fewer resources:
– Faster to complete
– Easier to manage
• Data collection & analysis only
– Less expensive
• Expanded research potential
– Study multiple outcomes
– Address rare diseases

4. • Risk of bias during:
– Selection (Selection Bias)
– Data Collection (Information Bias)
– Analysis and Interpretation (Confounding
Bias)
• No control over assessments or
treatments
Disadvantages of
Retrospective Clinical Studies

5. • Gain new information:
– Understand product use & cost in routine
clinical care
– Compare outcomes across sub-populations
– Compare Treatment A with Treatment B
– Develop hypotheses for future study
Why Conduct a Retrospective
Clinical Study?

6. How to Maximize Study Validity
• Develop a Statistically Valid Protocol
− Create clear objectives
− Describe limitations due to operational differences
of variables across centers
− Describe limitations due to time effects on
population, exposures and outcomes
− Prepare an unbiased sampling plan
− Plan through stratification and analytical
techniques to address confounding bias

7. How to Maximize Data Reliability &
Validity
• Create a Comprehensive Data
Management Plan
− Data collection methods
• Chart review, electronic extracts, de-identification
of records
− Methods to link data over multiple sources
− Database management

8. How to Maximize Data Reliability &
Validity
• Protect data with a quality assurance plan
that includes:
– Data checking for logical and systematic
errors and inconsistencies
– Risk-based source verification plan
• Use regulatory compliant software
solutions and processes

9. How to Staff Retrospective
Study Teams
Clinicians
• Disease outcomes and treatments, data
sources, variable definitions and coding
Statisticians
• Study design, database design, analysis
plans, statistical analysis, reporting

10. Data Managers
• Database design, quality assurance plans,
software support, data review
Sponsors
• Business development, clinical and regulatory
affairs
How to Staff Retrospective
Study Teams

11. BSI Expertise and Commitment
• Study design and statistical analysis
• Retrospective and prospective clinical studies
• Regulatory-compliant data collection software (rED
Cap® ) for efficient and cost-effective data
management
• Committed to Sponsor timelines and business
goals

12. BioStat International
• Founded in 1994 by Maureen Lyden
• High quality, client-focused biostatistical and
data management services
• Retrospective studies, Phase I-IV trials,
registry, and medical device feasibility and
pivotal trials
Let’s Talk!
813.979.1619
info@biostatinc.com
http://www.biostatinc.com