Journal of Clinical Gynecology and Obstetrics, ISSN 1927-1271 print, 1927-128X online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Gynecol Obstet and Elmer Press Inc
Journal website https://jcgo.elmerpub.com

Review

Volume 15, Number 1, March 2026, pages 13-18

Reflections on the Challenges of Infertility-Based Randomized Controlled Trials

Table

↓  Table 1. Responsibility Related to Trial Associated Activities in Pharma-Sponsored, Investigator-Initiated Trials and Our Own RCT
 
Pharma-sponsored Investigator-initiated Our own RCT
IRB: Institutional Review Board; RCT: randomized controlled trial.
Hypothesis generation By sponsor By investigator By chief investigator
Preparation of the protocol By sponsor By investigator By chief investigator
Recruitment of co-investigators: feasibility questionnaire By sponsor/monitoring company By investigator in person/online discussion Pre-study online discussion
Determining the interventions/arms By sponsor By investigator By chief investigator
Setting up the inclusion-exclusion criteria By sponsor By investigator By chief investigator
Determining the 1° and 2° outcomes By sponsor By investigator By chief investigator
Sample size calculation By sponsor By investigator By chief investigator
Randomization By sponsor; central list, proper concealment By investigator; central list, concealment may be an issue Randomization list prepared by statistician, central access, concealment problematic
Blinding Arranged by sponsor if blinding is needed/possible Often problematic Providers/patients not blinded to treatment
Placebo group If required, arranged by sponsor Rarely used; Who prepares the placebo? Who pays for it? There was no placebo group
Statistical methods By sponsor By investigator/statistician By statistician
Single-center vs. multi-center RCT Almost always multi-center Mostly single center Multicenter
IRB approval Monitoring company By investigator By chief investigator
Local ethical procedures Monitoring company By investigator By chief investigator
Insurance By investigator By investigator or no extra insurance Additional insurance was mandated by regulatory authorities
Trial registration By sponsor By investigator By chief investigator in ClinicalTrials
Funding By sponsor None or through funds None
Data collection By sponsor and monitoring company By investigator(s) Chief and local investigators
Patient enrollment/maintenance Local investigators By investigator(s) Local investigators
Periodic follow-up By sponsor and monitoring company By chief investigator or none Only ad hoc follow-up, no regular follow-up
Statistical analysis By sponsor By investigator/statistician By chief investigators
Publication - publication expenses By sponsor By investigator By investigator, no funding, open access publication not an option