Preview

FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

Advanced search

ROLE OF RANDOMIZED TRIALS IN PHARMACOEPIDEMIOLOGY

Full Text:

Abstract

Abstract: pharmacoepidemiology has recently evolved into a self-dependent post-marketing disciplinefrom clinical pharmacology, borrowing its methodology and analyticaltools from epidemiology. The article describes the goals of pharmacoepidemiology and provides introduction to randomized designs in post-marketing drug research by the example of large simple trials.

About the Authors

T. L. Galankin
The first St. Petersburg State Medical University named after Academician Pavlov
Russian Federation


A. S. Kolbin
The first St. Petersburg State Medical University named after Academician Pavlov; Saint Petersburg State University
Russian Federation


References

1. Vlasov V.V., Last Dzh.M. i dr. Jepidemiologicheskij slovar'. 4-e izdanie. Pod redakciej Dzh. Lasta; redakcija perevoda. M., 316 s.

2. Kolbin A.S., Zyrjanov S.K., Belousov D.Ju. Osnovnye ponjatija v ocenke medicinskih tehnologij: metod. posob. M. 2013. 42 s.

3. Melihov O.G. Klinicheskie issledovanija. M. 2000; 200 s.

4. Strachunskij L.S., Kozlov S.N., Rachina S.A. Farmakojepidemiologija:osnovnye ponjatija i prakticheskoe primenenie. Klinicheskaja farmakologija i terapija. 2001; 10 (4): 48-53.

5. Fletcher R., Fletcher S., Vagner Je. Klinicheskaja jepidemiologija. Osnovy dokazatel'noj mediciny. Per. s angl. M. 1998; 347 s.

6. Calenda E., Tourrel F. Sinoatrial block induced by timololeyedrops. Can. J. Ophthalmol. 2007; 42 (1): 149 p.

7. Dawson L. The Salk Polio Vaccine Trial of 1954: risks, randomization and public involvement in research. Clin. Trials. 2004; 1 (1): 122-30.

8. Francis T.Jr., Korns R., Voight R. et al. An evaluation of the 1954 poliomyelitis vaccine trials: summary report. Am. J. Public. Health. 1955; 45: 1-50.

9. Fisher B., Costantion J.P., Wickerham D.L. et al.Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J. Natl. Cancer. Inst. 1998; 90:1371-88.

10. Gray R., Clarke M., Collins R., et al. Making randomized trials larger: a simple solution? Eur. J. Surg. Oncol. 1995; 2: 137-9.

11. Hasford J. Drug risk assessment: a case for large trials with lean protocols. Pharmacoepidemiol. Drug. Saf. 1994; 3: 321-7.

12. Herbst A.L., Ulfelder H., Poskanzer D.C. Adenocarcinoma of the vagina: association of maternal stilbestrol therapy with tumor appearance in young women. N. Engl. J. Med. 1971; 284: 878-81.

13. Kaiserman I., Fendyur A., Vinker S. Topical beta blockers in asthmatic patients-is it safe? Curr Eye Res. 2009; 34 (7): 517-22.

14. Lesko S.M., Mitchell A.A. An assessment of the safety of pediatric ibuprofen: a practitioner-based randomized clinical trial. JAMA. 1995; 273: 929-33.

15. Slone D., Shapiro S., Miettinen O.S. et al. Drug evaluation after marketing. A policy perspective. Ann. Intern. Med. 1979; 90: 257-61.

16. Strom B.L., Kimmel S.E., Hennessy S. Textbook of Pharmacoepidemiology. 2nd edition. Wiley-Blackwell. 2013; 480 p.

17. Yusuf S., Collins R., Peto R. Why do we need some large, simple randomized trials? Stat. Med. 1984; 3: 409-20.


For citation:


Galankin T.L., Kolbin A.S. ROLE OF RANDOMIZED TRIALS IN PHARMACOEPIDEMIOLOGY. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2014;7(1):4-8. (In Russ.)

Views: 310


ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)