1 / 30

Databases or Registries? Points to Consider

Databases or Registries? Points to Consider. Mary Lou Skovron, DrPH Group Director, Global Epidemiology Bristol-Myers Squibb FDA/Industry Statistics Workshop September 29, 2006. Overview. Claims databases Types Advantages Limitations Registries Types Advantages Limitations Examples

abe
Download Presentation

Databases or Registries? Points to Consider

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Databases or Registries? Points to Consider Mary Lou Skovron, DrPH Group Director, Global Epidemiology Bristol-Myers Squibb FDA/Industry Statistics Workshop September 29, 2006

  2. Overview • Claims databases • Types • Advantages • Limitations • Registries • Types • Advantages • Limitations • Examples • Conclusions

  3. Claims Databases

  4. Claims DatabasesTypes • Open-Plan eg UHC, PharMetrics • Pharmacy-based • Practice-based • Hospital-based • HMO, eg Kaiser-Permanente • Government eg Medicare, Medicaid

  5. Claims Databases:Advantages • Already exist, accruing patient information…useful when a relatively quick answer is needed • Potentially large populations from which to draw treated patient and comparison samples…statistical power not usually an issue • May include subgroups not included in clinical trials…expand knowledge

  6. Claims Databases:Limitations • ICD-9 coding… potential for misclassification • Limited sensitivity/specificity • Coding affected by reimbursement • Short ‘residence’ in the database • Clinical, lab, imaging data not usually present • Rare events in rare diseases require huge “electronic” populations to identify adequate numbers treated • May not represent important sub-populations • Surveillance bias and channeling bias • Inpatient drug exposures not usually recorded

  7. Claims Databases: Application • Acute events (short-term events) • Events that come to medical attention, eg CVA • Validated algorithm to identify indication and event of interest OR medical record review to verify events • Statistical approaches for confounders (eg propensity scores, instrumental variables, risk factor scores, multivariate analyses)

  8. Registries

  9. Registries • “A systematic collection of defined events or product exposures in a defined patient population for a defined period of time”1 • “A registry per se is not a study. It is an organized collection of data in humans within a particular disease group or other special group…”2 1Arlett P, Moseley J, Seligman PJ p 119 in Pharmacoepidemiology Fourth Edition, Strom BL, ed 2005 2 CIOMS V Section II.h.

  10. Registries:Types • Drug/Device Registry: Includes subjects receiving the drug or device regardless of indication • Disease Registry: Includes patients with the disease regardless of drug or device exposure

  11. Registries:Strengths • Richer data than in electronic databases: Patient SES, history, treatment, clinical data can be collected • Define encounter frequency and follow-up duration • Event ascertainment does not depend on ICD-9 coding • Can address additional questions in the data

  12. Registries:Limitations • Accrual can be slow if insufficient sites engaged • Generalizability must be established • Practical limits on number of patients followed

  13. Registries:Application • Long-term outcomes • Rare diseases • Potential confounders important • Multiple objectives

  14. Usefulness of Registries • Characteristics of patients in the target population for the new drug • Clinical course of the disease • Treatment patterns, health care utilization • Frequency of adverse events

  15. Registry Lifecycle • Early: Describe patient demographics, clinical characteristics, practice patterns (usually cross-sectional analyses); incidence of AEs with short lag times • Intermediate: Analyze relationships pf patient characteristics, treatment with outcomes; incidence of less common AEs, AEs with longer lag times; assess risk factors for AE incidence • Advanced: Evaluate changes in practice patterns; impact on outcomes and AE incidence; assess rare AE incidence

  16. Registry Quality • DeCIDE Network currently developing a reference document on developing, conducting and evaluating registries • Sponsored by AHRQ • Document in draft, Outline available on the web • Report currently in draft

  17. Examples

  18. Example:Cox-2 Inhibitors and Cardiac Events • Cox-2 use frequent in population • Primary care drug • Cardiac events not rare in target population • Short-term (< 2 years) events • Clinical history important

  19. One SolutionCox-2 Inhibitors and Cardiac Events • Claims database analysis1 • Advantages: • Data already accrued when study need identified • Large population • Limitation offset • Multivariate regression to control confounding • Verified cardiac events by chart review • Remaining limitations • Under-represented > 65 yo 1Velentgas P et al 2006

  20. Key Feature of the Solution • Numbers readily available: • Exposure: ~ 425,000 eligible subjects available for study • at least one dispensing of the 5 study medications during preceding 18-month period • first dispensing after minimum of six months without any of the medications • Endpoint: ~ 725 confirmed MI/ACS • Verification of endpoints • Medial record review applying accepted criteria

  21. Example:Thrombolytics And Bleeding • Important focus: subpopulations eg ethnicity, gender, age • Short-term event • Benefit and risk • Hospital-based treatment

  22. SolutionThrombolytics and Bleeding • Registry approach: National Registry of Myocardial Infarctions • Salient strengths: • Clinical and lab data ascertained • Data from medical records • Limitation Offset • Validated completeness against another data source • Large number of hospitals to assure adequate subpopulations • Remaining limitations • Short-term data cannot answer long-term questions

  23. Key Feature of the Solution • Large number of hospitals participate order to gather data on~200,000 MIs per year • Rich patient, clinical, treatment and outcome information • Answered the question about safety in subgroups under-represented in the clinical trials • In its > 10 year lifecycle has contributed to broad understanding and improvement of medical practice • External investigators can propose research; external advisory group reviews and approves all research

  24. Example: Safety of Orencia®, a New Biological for RA • Short-term (infections) and longer-term (NHL and other malignancies) events • Low general population prevalence of RA candidates for biologics treatment • RA a specialty-treated disorder • Proactive approach

  25. Solution: Complementary Approaches • Claims database study in UHC data • Event validation • Large pool of potential comparators • Population treatment patterns • Infections, other possible short-term events • Registry building on the independently conducted National databank for Rheumatic Diseases • Large pool of participating rheumatologists • 5,000 Orencia® initiators comparison to >=15,000 initiators/switchers of other treatments • Patient self-report and event verification • Enrollment and retention enhancements • Short and long-term events

  26. Key Features of the Solution • External scientific advisory group • Individual protocols • Statistical analysis plans • Interpretation of results including approaches to integration

  27. Conclusions

  28. Conclusions • One size does not fit all: evaluate options • Registries: a useful alternative to electronic databases • Consider complementary approaches

  29. Useful References • Strom BL, ed; Pharmacoepidemiology 4th Edition; UK; John Wiley and Sons Ltd;2005 • AHRQ DeCIDE Network upcoming publication • http://effectivehealthcare.ahrq.gov/decide/

  30. Thank You

More Related