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'Model' versus 'everyday' patients: can randomized controlled trial data really be applied to the clinic?
Eliyakim Hershkop1, Linoy Segal1, Ofer Fainaru2
1Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa 3109601, Israel.
Reproductive Biomedicine Online
|December 31, 2016
Summary
Most patients undergoing assisted reproduction treatments do not meet the strict inclusion criteria of clinical trials. This highlights a gap between trial populations and real-world patients seeking fertility treatments.
Area of Science:
- Reproductive Medicine
- Clinical Trial Design
- In Vitro Fertilization
Background:
- Drug approval relies on rigorous clinical trials to establish efficacy and safety.
- Approved drugs are indicated only for populations matching trial inclusion criteria.
- Assisted reproduction treatments involve complex patient demographics and clinical histories.
Purpose of the Study:
- To assess the proportion of "real-world" patients in an assisted reproduction setting who meet criteria for major clinical trials.
- To identify demographic and clinical factors influencing patient eligibility for clinical trials in fertility treatment.
- To evaluate the generalizability of clinical trial findings to the broader patient population undergoing IVF.
Main Methods:
- Retrospective analysis of 265 consecutive patients treated at a tertiary IVF Unit in 2015.
- Comparison of patient demographic and clinical parameters against inclusion/exclusion criteria from nine major drug registration trials.
- Statistical analysis to determine the percentage of patients meeting consensus inclusion criteria.
Main Results:
- Only 37% (97 out of 265) of surveyed patients met the consensus inclusion criteria from the nine clinical trials.
- Patients meeting inclusion criteria had a higher mean number of oocytes retrieved (9.10 ± 5.34) compared to those who did not (6.90 ± 5.23).
- A significant majority of "real-life" patients at a tertiary IVF center did not meet the established clinical trial criteria.
Conclusions:
- Most patients seeking assisted reproduction at tertiary centers do not fulfill the stringent inclusion and exclusion criteria used in major clinical trials.
- This discrepancy raises questions about the direct applicability of clinical trial results to the general patient population in assisted reproduction.
- Future research should consider broader patient populations in clinical trials or explore methods to bridge the gap between trial evidence and clinical practice.
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