2018
The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials
Diamond MP, Eisenberg E, Huang H, Coutifaris C, Legro RS, Hansen KR, Steiner AZ, Cedars M, Barnhart K, Ziolek T, Thomas TR, Maurer K, Krawetz SA, Wild RA, Trussell J, Santoro N, Zhang H, Network F. The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials. Clinical Trials 2018, 16: 3-10. PMID: 30354458, PMCID: PMC6384136, DOI: 10.1177/1740774518807888.Peer-Reviewed Original ResearchConceptsInstitutional review boardReproductive Medicine NetworkPast clinical trialsClinical trialsReview boardChild healthNational InstituteClinical researchMedicine NetworkSingle institutional review boardInstitutional review board approvalCurrent clinical trialsInstitutional review board submissionLocal institutional review boardReview board approval
2011
Recruitment challenges of a multicenter randomized controlled varicocelectomy trial
Trussell JC, Christman GM, Ohl DA, Legro RS, Krawetz SA, Snyder PJ, Patrizio P, Polotsky AJ, Diamond MP, Casson PR, Coutifaris C, Barnhart K, Brzyski RG, Schlaff WD, Meacham R, Shin D, Thomas T, Zhang M, Santoro N, Eisenberg E, Zhang H, Network R. Recruitment challenges of a multicenter randomized controlled varicocelectomy trial. Fertility And Sterility 2011, 96: 1299-1305. PMID: 22130101, PMCID: PMC3243664, DOI: 10.1016/j.fertnstert.2011.10.025.Peer-Reviewed Original ResearchConceptsReproductive Medicine NetworkPlacebo armInfertility evaluationIntrauterine inseminationMedicine NetworkSuboptimal recruitmentClinical trial enrollmentMale infertility studiesAscertain reasonsIUI cyclesInfertile womenTrial enrollmentSurgical interventionPatient educationMAIN OUTCOMEStudy recruitmentInfertile menMale infertilityStudy participantsInfertility studiesMale partnersRecruitment challengesTrialsInadequate recruitmentFertility interventionsIncreasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies
Schlaff WD, Zhang H, Diamond MP, Coutifaris C, Casson PR, Brzyski RG, Christman GM, Barnhart KT, Trussell JC, Krawetz SA, Snyder PJ, Ohl D, Santoro N, Eisenberg E, Huang H, Legro RS, Network R. Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies. Fertility And Sterility 2011, 96: 15-18. PMID: 21645894, PMCID: PMC3151556, DOI: 10.1016/j.fertnstert.2011.05.069.Peer-Reviewed Original ResearchConceptsPolycystic Ovary Syndrome IReproductive Medicine NetworkMulticenter clinical trialMulticenter trialClinical trialsSubstantial burdenInstitutional reviewClinical investigatorsMedicine NetworkSignificant increaseBurdenTrialsInstitutional review board requirementsObjective dataIRB submissionPregnancyInfertilityHuman research participantsYearsSignificant variability