Project Details
Description
The Alliance for Clinical Trials in Oncology (Alliance) was founded on July 15, 2011, through the
merger of 3 legacy groups: Cancer and Leukemia Group B, North Central Cancer Treatment
Group, and American College of Surgeons Oncology Group. The Alliance Statistics and Data
Management Center (SDMC) is responsible for all statistics, data management, and Information
Technology functions for the Alliance and, as such, is an integral part of the Alliance’s mission.
Despite being formed from 3 distinctive groups, all SDMC activities are now consolidated at a
single location at the Mayo Clinic under the leadership of Dr. Sumithra Mandrekar as the
Alliance Group Statistician, all while undergoing a leadership transition due to the untimely
death of the previous group statistician, Dr. Daniel Sargent. Alliance faculty includes
methodological leaders in biomarker-based clinical trial design, adaptive trials, surrogate
endpoint evaluations, development of methodology and computing tools for identification of
predictive genomic markers, and early-stage clinical trial design. From March 1, 2014 – August
31, 2017, the SDMC provided statistical, data management, and IT collaboration for 20
treatment trials currently in development, 21 treatment trials that opened to accrual and, 100
trials that opened prior to March 2014, for which patient follow-up or manuscript preparation is
in progress. SDMC members were authors on 234 published manuscripts reporting on Allianceled
clinical trials and associated correlative or retrospective studies, authored an additional 149
reviews, editorials, or position papers on novel statistical and bioinformatics methods, analyses
and software, and provided substantial statistical support and leadership on 44 publications
which leverage individual patient data from multiple Alliance studies. SDMC systems are robust
and scalable and support all needs of the Alliance. The SDMC has implemented Medidata Rave
for all trials, consolidated to a single information systems infrastructure, met all NCI OEWG
timelines, collaborated on international trials, partnered on prospective and retrospective
registration trials, and is leading the ALCHEMIST trial, A151216 (part of the NCI precision
medicine initiative). The SDMC has contributed to several national NCTN systems initiatives:
piloting of the ePRO system, Source Data Verification, integrations between Rave and CTEPAERs,
implementing the Data Quality Portal and Central Monitoring Portal, and partnering on
the NCTN Biospecimen Navigator. The Alliance SDMC has kept pace with, and in many cases
led, innovation in scientific, administrative, and technological arenas of cancer research, and is
ideally poised to meet the challenges of cancer clinical trials in 2018 and beyond.
Status | Finished |
---|---|
Effective start/end date | 4/3/19 → 2/29/24 |
Funding
- National Cancer Institute: $471,234.00
Fingerprint
Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.