'Model' versus 'everyday' patients: can randomized controlled trial data really be applied to the clinic?

REPRODUCTIVE BIOMEDICINE ONLINE

卷:34

Article

Hershkop, Eliyakim¹  Segal, Linoy¹  Fainaru, Ofer^1,2  Kol, Shahar^1,2 

[1] Technion Israel Inst Technol, Ruth & Bruce Rappaport Fac Med, IL-3109601 Haifa, Israel

[2] Dept Obstet & Gynecol, IVF Unit, Rambam Hlth Care Campus, IL-3109601 Haifa, Israel

关键词: Evidence-based medicine;    Exclusion criteria;    Inclusion criteria;    IVF;    Randomized controlled trials;   

DOI  :  10.1016/j.rbmo.2016.11.010

来源: Elsevier

【 摘 要 】

New drug approval requires a new drug to undergo rigorous clinical trials to determine its efficacy and safety. A drug is approved only for the population on which it was tested, i.e. those who meet the inclusion criteria of the trial. The aim of this study was to determine what percentage of 'real life' patients in our clinic meet the inclusion and exclusion criteria used in large-scale clinical trials required for drug registration in the field of assisted reproduction. All 265 consecutive patients with pertinent data treated in a tertiary centre IVF Unit during 2015 were surveyed. Their demographic and clinical parameters were compared with inclusion and exclusion criteria used in nine major clinical trials. Only 97 out of 265 137%1 patients met the consensus inclusion criteria as defined by the nine clinical trials. The number of oocytes retrieved was 9.10 +/- 5.34 in the patients that met the inclusion criteria (n = 97) versus 6.90 +/- 5.23 (P = 0.00122) in those that did not (n = 168). Most 'real life' patients who come for treatment at a tertiary IVF centre do not meet the consensus of inclusion and exclusion criteria used for major clinical trials. (C) 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

【 授权许可】

Free