Skip to main content

Assessing Possible Late Treatment Effects Early: The Diabetic Retinopathy Study Experience

  • Chapter
Data Monitoring in Clinical Trials
  • 1322 Accesses

Abstract

The Diabetic Retinopathy Study (DRS) assessed the ability of photocoagulation to delay or prevent severe visual loss in people with proliferative diabetic retinopathy. Benefit was detected early, but there where concerns about the possibility of late adverse effects. Calculations using projected blindness and death rates reassured the data monitoring committee that even large late adverse affects would not offset the early benefit already observed.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Ederer F, Podgor MJ, and The Diabetic Retinopathy Study Research Group. 1984. Assessing possible late effects of in stopping a clinical trial early: A case study. Diabetic Retinopathy Study Report No. 9. Control Clin Trials 5:373–381.

    Article  Google Scholar 

  2. Ederer F, Hiller R. 1975. Clinical trials, diabetic retinopathy, and photocoagulation: A reanalysis of five studies. Surv Ophthalmol 19:267–286.

    Google Scholar 

  3. The Diabetic Retinopathy Study Research Group. 1981. Diabetic Retinopathy Study Report Number 6: Design, methods, and baseline results. Invest Ophthalmol Vis Sci 21:149–209.

    Google Scholar 

  4. The Diabetic Retinopathy Study Research Group. 1976. Preliminary report on effects of photocoagulation therapy. Am J Ophthalmol 81:383–396.

    Google Scholar 

  5. Francois J, DeLaey JJ, Cambie E, Hanssens M, Victoria-Troncoso V. 1975. Neovascularization after argon laser photocoagulation of macular lesions. Am J Ophthalmol 79:206–210.

    Google Scholar 

  6. Davis MD, Hiller, R, Magli YL, Podgor MJ, Ederer F, Harris W A, et al. 1979. Prognosis for life in patients with diabetes: Relation to severity of retinopathy. Trans Am Ophthalmol Soc LXXVII:144–170.

    Google Scholar 

  7. Cutler SJ, Ederer F. 1958. Maximum utilization of the life table method in analyzing survival. J Chronic Dis 8:699–712.

    Article  Google Scholar 

  8. Bayo F. United States Life Tables by Causes of Death: 1959–61, Vol 1, No. 6, National Center for Health Statistics, Public Health Service Publication No. 1252, U.S. Dept. HEW, Washington, DC, May 1968.

    Google Scholar 

  9. Berg JW. 1964. Disease-oriented end results. A tool for pathological clinical analysis. Cancer 17:693–707.

    Article  Google Scholar 

  10. Ederer F, Podgor MJ. 1978. Estimates of a hypothetical delayed deleterious effect of photocoagulation treatment for diabetic retinopathy. Office of Biometry and Epidemiology. National Eye Institute. Biometrics Note No. 6, February.

    Google Scholar 

  11. The Coronary Drug Project Research Group. 1981. Practical aspects of decision making in clinical trials: The Coronary Drug Project as a case study. Control Clin Trials 1:367–376.

    Google Scholar 

  12. The Diabetic Retinopathy Study Research Group. Unpublished data

    Google Scholar 

  13. The Diabetic Retinopathy Study Research Group. 1978. Photocoagulation treatment of proliferative diabetic retinopathy. The second report of the Diabetic Retinopathy Study. Ophthalmology 85:82–106.

    Google Scholar 

  14. The Diabetic Retinopathy Study Research Group. 1981. Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings. DRS Report Number 8. Ophthalmology 88:583–600.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2006 Springer Science+Business Media, Inc.

About this chapter

Cite this chapter

Ederer, F. (2006). Assessing Possible Late Treatment Effects Early: The Diabetic Retinopathy Study Experience. In: DeMets, D.L., Furberg, C.D., Friedman, L.M. (eds) Data Monitoring in Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/0-387-30107-0_5

Download citation

Publish with us

Policies and ethics