E-Newsletter - February 2018
Message from the Group Statistician

A Closer Look at the Alliance Statistics and Data Center (SDC)

It is just over a year since I became the Group Statistician for the Alliance. What an incredible year of success and accomplishments it has been for the SDC and the Alliance as a whole, including the submission of our competing renewal application. YAY!

Despite originally being formed from three distinctive groups, all SDC operations are now consolidated at a single location at the Mayo Clinic. Additionally, as of early 2018, all legacy CALGB systems will be retired and all legacy CALGB studies with ongoing data collection migrated to Medidata Rave®. The transition of the legacy electronic data capture systems for ACOSOG and NCCTG is underway and should be completed by 2020.This consolidation will provide the Alliance SDC considerable staffing flexibility, efficiencies in DM, IT, and statistical operations while providing the needed platforms for statistical innovation and discovery. We instituted a yearly statistical fellowship award in Innovative Clinical Trial Design and Methods in honor of Dr. Daniel J. Sargent, which was awarded to Dr. Vivien (Jun) Yin for 2018. We are the SDC for the National Biorepository to Advance Studies of Immune-Related Adverse Events to manage a centralized tissue and data repository for patients enrolled in clinical trials from across all NCTN groups who experience immune-related adverse events (irAEs).

Since the formation of the Alliance SDC in 2014, we have provided statistical, data management, and IT collaboration and support for all Alliance coordinated treatment and NCORP trials, including more than 150 trials for which patient follow-up is continuing or that are in manuscript preparation. The Alliance database currently contains records for more than 150,000 patients enrolled on to 891 Alliance and legacy group-led clinical trials spanning the period 1955 to present. SDC members continue to be on the cutting edge of statistical and methodological research, publishing extensively on novel statistical and bioinformatics methods, analyses and software, and providing statistical support and leadership on publications which leverage individual patient data from multiple Alliance studies. In 2017, the Alliance SDC provided statistical leadership and collaboration for the IDEA collaboration (ASCO Plenary), and three FDA registrations/approvals (C100104, C10603 and A031203).

In 2017, the SDMC contributed to several national NCTN systems initiatives: piloting of the ePRO system, Source Data Verification, integrations between Rave and CTEP-AERs, implementing the Data Quality Portal and Central Monitoring Portal, and partnering on the NCTN Biospecimen Navigator. In working with the Translational Research Program (TRP) leadership, we are currently piloting a solution for storing and sharing bioinformatics data, with secure data transmission, complete audit trail for all transfer activity, and simultaneous user access. This was launched in October 2017. The scope of this pilot is to gather usage metrics (storage needed, infrastructure and workflow), and the platform requirements for the long-term solution.

Meet the Alliance SDC Leadership Team
Associate Group Statistician: Dr. Ann Oberg
Operations Administrator: Cari Cummins
Directors of Statistics: Drs. Xiaofei Wang and Qian Shi
Director of Computational Genomics and Bioinformatics: Dr. Ann Oberg
Directors of Data Management: Jenny Darcy and Marcia Wilson
Director of Information Systems: Michael Carston
Director of Clinical Trials Systems Support Services: Andrea Jacobsen
Director of Statistical Systems and Integrations: Shauna Hillman

Thank you all for your support and cooperation as we worked through the many transitions over the last few years. I remain dedicated and committed to the Alliance as we continue to look forward to the exciting changes the years ahead will bring.

Wishing everyone a joyous and peaceful 2018.


 

Sumithra J. Mandrekar, PhD

 

For other articles in this issue of the Alliance E-News newsletter, see below.