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Bsi retrospective clinical studies slide share_22apr13_ (2)

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Bsi retrospective clinical studies slide share_22apr13_ (2)

  1. 1. Guidelines for ConductingClinical ResearchUsing Retrospective Data
  2. 2. What is a RetrospectiveClinical Study?• Retrospective studies are observational– They “look back” at data recorded forpurposes other than current research• Examples: Medical records and claims data– No protocol interventions regardingobservations and measurements
  3. 3. Advantages ofRetrospective 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. 4. • Risk of bias during:– Selection (Selection Bias)– Data Collection (Information Bias)– Analysis and Interpretation (ConfoundingBias)• No control over assessments ortreatmentsDisadvantages ofRetrospective Clinical Studies
  5. 5. • Gain new information:– Understand product use & cost in routineclinical care– Compare outcomes across sub-populations– Compare Treatment A with Treatment B– Develop hypotheses for future studyWhy Conduct a RetrospectiveClinical Study?
  6. 6. How to Maximize Study Validity• Develop a Statistically Valid Protocol− Create clear objectives− Describe limitations due to operational differencesof variables across centers− Describe limitations due to time effects onpopulation, exposures and outcomes− Prepare an unbiased sampling plan− Plan through stratification and analyticaltechniques to address confounding bias
  7. 7. How to Maximize Data Reliability &Validity• Create a Comprehensive DataManagement Plan− Data collection methods• Chart review, electronic extracts, de-identificationof records− Methods to link data over multiple sources− Database management
  8. 8. How to Maximize Data Reliability &Validity• Protect data with a quality assurance planthat includes:– Data checking for logical and systematicerrors and inconsistencies– Risk-based source verification plan• Use regulatory compliant softwaresolutions and processes
  9. 9. How to Staff RetrospectiveStudy TeamsClinicians• Disease outcomes and treatments, datasources, variable definitions and codingStatisticians• Study design, database design, analysisplans, statistical analysis, reporting
  10. 10. Data Managers• Database design, quality assurance plans,software support, data reviewSponsors• Business development, clinical and regulatoryaffairsHow to Staff RetrospectiveStudy Teams
  11. 11. BSI Expertise and Commitment• Study design and statistical analysis• Retrospective and prospective clinical studies• Regulatory-compliant data collection software (rEDCap® ) for efficient and cost-effective datamanagement• Committed to Sponsor timelines and businessgoals
  12. 12. BioStat International• Founded in 1994 by Maureen Lyden• High quality, client-focused biostatistical anddata management services• Retrospective studies, Phase I-IV trials,registry, and medical device feasibility andpivotal trialsLet’s Talk!813.979.1619info@biostatinc.comhttp://www.biostatinc.com

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