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.
William D Schlaff, Heping Zhang, Michael P Diamond, Christos Coutifaris, Peter R Casson, Robert G Brzyski, Gregory M Christman, Kurt T Barnhart, J C Trussell, Stephen A Krawetz and 7 more
2 registry-linked trialsOpen access · greenAbstract readClinical TrialComparative StudyMulticenter Study
Trial report in Fertility and sterility, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.
0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 23% of its field
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pregnancy in Polycystic Ovary Syndrome: A 30 Week Double-Blind Randomized Trial of Clomiphene Citrate, Metformin XR, and Combined Clomiphene Citrate/Metformin XR For the Treatment of Infertility in Women With Polycystic Ovary Syndrome
TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2002 to 2006Enrolled678ConditionsPolycystic Ovary Syndrome, Infertility, PregnancyArmsmetformin XR, clomiphene citrate
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what money
Authors and funding
17 authors at 10 institutions in 1 country.
William D SchlaffDepartment of Obstetrics and Gynecology, University of Colorado School of Medicine, Academic Office Building 1, 12631 E. 17th Avenue, Aurora, CO 80045, USA. william.schlaff@ucdenver.edu
Heping Zhang
Michael P Diamond
Christos Coutifaris
Peter R Casson
Robert G Brzyski
Gregory M Christman
Kurt T Barnhart
J C Trussell
Stephen A Krawetz
Peter J Snyder
Dana Ohl
Nanette Santoro
Esther Eisenberg
Hao Huang
Richard S Legro
Reproductive Medicine Network
University of Pennsylvania · USUniversity of Colorado Denver · USUniversity of Michigan–Ann Arbor · USWayne State University · USYale University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USPennsylvania State University · USSUNY Upstate Medical University · USThe University of Texas Health Science Center at San Antonio · USUniversity of Vermont · US
Funding
Data Coordination Center for the RMNU10HD055925 · NICHD · YALE UNIVERSITY · PI ZHANG, HEPING · 2007 to 2019
$39.2M
WRITING AND THE DAILY EXPERIENCE OF ILLNESSM01RR010732 · NCRR · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI DONG, CHENG · 1995 to 2009
$29.8M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD027049 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI COUTIFARIS, CHRISTOS · 1990 to 2017
$5.2M
GHSU/WSU Cooperative Reproductive Medicine NetworkU10HD039005 · NICHD · WAYNE STATE UNIVERSITY · PI DIAMOND, MICHAEL PETER · 2000 to 2017
$5.2M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD038992 · NICHD · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI LEGRO, RICHARD S. · 2000 to 2017
$5.0M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD038998 · NICHD · UNIVERSITY OF COLORADO DENVER · PI POLOTSKY, ALEX JOEL · 2000 to 2015
$2.6M
Cooperative Multicenter Reproductive Medicine Network (U10)U10HD055936 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SMITH, YOLANDA R · 2007 to 2014
$2.1M
The Utility of Empiric Medical Treatment of Infertile Oligo-asthenospermic MenU10HD055944 · NICHD · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI MCGEE, ELIZABETH A · 2007 to 2013
$2.1M
Letrozole Therapy for IVF/ET: Effects on Multiple Pregnancy and Treatment BurdenU10HD055942 · NICHD · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI ROBINSON, RANDAL D. · 2007 to 2015
$1.7M
GCRC RELOCATION AND EXPANSION PROJECTC06RR016499 · NCRR · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KIRCH, DARRELL G · 2001 to 2001
unlabelledMany clinical investigators think that the burden of Institutional Review Board (IRB) requirements has been consistently increasing over recent years, although there are few objective data describing these trends. Over a period of 7 years, the Reproductive Medicine Network observed a significant increase in the size and requirements of IRB submissions and significant variability of IRB performance in reviewing multicenter trials. These additional regulatory and administrative demands represent substantial burdens to researchers and to the IRBs themselves. It is timely to consider whether these changes better protect the interests and safety of human research participants. CLINICAL
trial registrationClinicalTrials.gov NCT00068861 and NCT00719186.
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.
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. · full record | OpenQuestion