Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT).
Nancy J ButcherAndrea MonsourEmma J MewPeter SzatmariAgostino PierroLauren E KellyMufiza Farid-KapadiaAlyssandra Chee-A-TowLeena SaeedSuneeta MongaWendy UngarCaroline B TerweeSunita VohraDean A FergussonLisa M AskiePaula R WilliamsonAn-Wen ChanDavid MoherMartin OffringaPublished in: Trials (2019)
InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.