E-Newsletter - May 2021
Message From the Group Statistician


2020 was a year of resilience, patience, perseverance and commitment. Despite the bumps and challenges created by the pandemic that disrupted both personal and professional lives, we at the Alliance Statistics and Data Management Center (SDMC) continued to push forward to make 2020 yet another outstanding year of progress and accomplishments for us at the SDMC.

Here’s a high-level summary of the SDMC accomplishments for 2020:

  • The Alliance SDMC responded quickly and efficiently to the need to collect information about COVID-19 and impacts to Alliance clinical trials. A COVID-19 central database was created to capture COVID-related events, including withdrawal from treatment or study follow-up due to COVID-19, positive testing and all related protocol deviations. The central database was activated in April 2020. Data submission guidelines and a frequently asked questions document were created to aid sites. A macro was also created to summarize COVID-19 deviations for CIRB reporting and to support study teams in the monitoring of this data. A protocol and analysis plan was created to evaluate COVID data across trials for broad impacts to Alliance Clinical Trials. As of Oct 2020, data collection spans across 59 trials, 397 sites and 1650 patients
  • The Alliance SDMC has successfully implemented CDASH standards (four trials activated using CDASH) with the Alliance global library updated, a central CDASH review team in place to ensure all new trials are compliant with the CDASH standards, and all systems integrations completed to implement new CDASH variables.
  • As part of the Alliance SDMC’s commitment to data sharing, the Alliance SDMC has submitted 42 data sets from 35 trials to the NCTN Archive; 17 of which are approved for public request; 43 trials, 24,659 patients and 384,986 specimens as of September 2020 are available in the NCTN Navigator; 148 trials with all primary and secondary endpoints reported in the CT.gov and 35 trials for which initial results have been released.
  • The Alliance SDMC continued efforts with the CTSU to enhance and test the Source Document Portal (SDP).
  • The Alliance SDMC retired legacy systems, including the Ingres database and related applications, and converted to the new Protocol Lifecycle Management (PLM) applications.
  • Immune-related adverse event database, a centralized tissue and data repository for patients enrolled in clinical trials from across all NCTN groups who experience immune-related adverse events (Alliance A151804), was activated in January 2020 and has enrolled 44 patients to date.
  • ePRO has been included in 10 Alliance trials as of Dec 2020 (6 actively enrolling, 2 recently activated, 2 closed to enrollment).
  • The iRECIST team has worked with the Alliance Immuno-Oncology Committee to develop a process to ensure that iRECIST is included in all future Alliance immunotherapy trials as appropriate as well as to develop templates for including iRECIST in both concepts and protocols.
  • The Alliance SDMC has shown substantial academic productivity, as demonstrated by the 70 Alliance or legacy group publications (58) and abstracts (12) from 2020 with an Alliance statistician listed as co-author. This includes: three abstracts and 23 manuscripts on primary endpoint results; one trial description abstract, six abstracts and 19 manuscripts on secondary analyses; two abstracts and 13 manuscripts on correlative analyses, and three manuscripts on methodology/design.
  • The Alliance SDMC continued to provide collaborative guidance to members of the Alliance Translational Research Program (TRP) Translational Informatics Committee in their efforts to build a repository for storing processed bioinformatics data such as genotype and variant calls or gene expression in a manner that provides straightforward analytical access for Alliance investigators, thereby facilitating generation of preliminary data.

Looking forward, following the aims outlined in the Alliance COVID-19 Pandemic protocol, the Alliance SDMC will work with the NCI on understanding the testing patterns by site, patient and time and evaluate the impact of the pandemic on the conduct of Alliance clinical trials. Alliance statisticians will continue to partner with the NCI, FDA, ASCO and Mitre on Integrating Clinical Trials and Real World Endpoints (ICARE) initiative, and the mCODE initiative. The Alliance SDMC will continue its data sharing commitments through the NCTN data archive, CT.gov, Navigator, and individual requests submitted to the Alliance for data that are not available in these archives. The Alliance SDMC will continue to streamline the processes for registration trials including developing formal training modules, updating the backend infrastructure to accommodate CDASH, and streamlining the process for tracking training and review of SOPs by SDMC members. Alliance faculty will continue to focus on the development of new and improved statistical designs, analyses, and methods of conduct for cancer clinical trials, and bioinformatics methods and analytical tools, and will regularly publish and provide recommendations to improve the overall standards of cancer clinical trials research. The Alliance SDMC will continue to be actively involved in various NCI committees and statistical and cancer research societies, including the precision medicine initiatives of the NCI such as ALCHEMIST, cMATCH, iMATCH, myeloMATCH, and other initiatives such as the irAE.

The Alliance SDMC remains dedicated and committed to innovation and cutting edge science and look forward to working with all Alliance members and its partners on the exciting initiatives the years ahead will bring.

We wish everyone a healthy, and peaceful rest of 2021.

Sumithra Mandrekar
Alliance Group Statistician

On behalf of the Alliance SDMC 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
Director of Data Management: Jenny Darcy
Director of Information Systems: Megan Williams
Director of Clinical Trials Systems Support Services: Andrea Jacobsen
Director of Statistical Systems and Integrations: Shauna Hillman



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