E-Newsletter - February 2017

Message from the Group statistician | suMithra Mandrekar, PhD
Alliance SDC: At the cutting edge of cancer research 

It is with mixed emotions that I write this first column in my new role as the Alliance Group Statistician. I was elected to this position In November 2016 after the untimely passing of Dr. Daniel J. Sargent, founding Alliance Group Statistician, in September 2016. Dan was a dear friend and mentor to me over these years, and I miss him greatly. I am deeply humbled and honored to take on this role to continue the great legacy he left behind. Dan’s contributions to the Alliance and to the field of Cancer Biostatistics are numerous and immeasurable. Over the years, he mentored and nurtured numerous faculty and staff at the Alliance Statistics and Data Center (SDC) whose work will continue for years to come. On behalf of the entire Alliance SDC, we will remember Dan fondly forever for his leadership, mentorship and the essential principles of clinical trials design and conduct he has taught us. 

The Alliance SDC continued its superb academic productivity in the last year, as demonstrated by the 95 Alliance or legacy group publications and abstracts from December 1, 2015 to November 15, 2016 with an Alliance statistician listed as co-author. Collectively since 2014, five of the top 10 Alliance publication authors, are SDC statisticians. Alliance statisticians remain active in statistical methodology work, contributing to 38 publications on statistical methods and clinical trial designs in statistical and medical journals, and 23 secondary analyses manuscripts. A total of 22 external grants motivated by Alliance studies have our statisticians as principal investigators and/or co-investigators. Alliance statisticians continue to remain actively involved in various national and NCI committees as well as statistical and cancer research societies.

Dan would always tell me, the Alliance SDC not only provides leadership and collaboration for statistical activities but also leadership, support and collaboration on the data management, and information technology needs for the Alliance and NCTN activities. A glimpse into the major accomplishments of the Alliance SDC operations since 2014 would be an apt tribute to Dan on his leadership and vision he had for the Alliance SDC.  

Major Operational Accomplishments of the Alliance Statistics and Data Center Since 2014

  1. All Alliance IT centralized at Mayo Clinic in Rochester, MN.
    1. Multiple enhancements were made to the Alliance RandoNode, including:
      1. Integrations with Rave, BioMS for patient instantiation
      2. Updated integrations for CTSU Transfer & Update Module
      3. Enhancements/integrations for new study designs, such as ALCHEMIST (A151216), and stratification factors blinded to the registering site (A041501)
  2. All Alliance Data Management activities centralized at Mayo Clinic (as of September 2015) -- in total 115 studies moved from Duke to Mayo Clinic.
  3. The facilitation of an online application that allows Study Chairs to access and signoff on study reviews (completed January 2016).
    1. The scanning of all paper documents for terminated and closed studies into an electronic document management system.
  4. The Alliance SDC now has extensive expertise in Medidata Rave study builds. As of November 2016, thirty-one Alliance trials are currently open to accrual in the Rave system, and the Alliance Rave Global Library contains 98 forms, more than 750 edit checks, and 53 custom functions. The ability to leverage these reusable components has decreased the timeline for Rave study builds to two months if the study maximizes use of the forms, edits, and custom functions in the global library.
  5. The Alliance SDC is a full partner in all relevant NCI/NCTN activities. The Alliance SDC successfully piloted the following initiatives with the NCI:
    1. The Central Data Repository allowing a unified, central data repository to maintain a subset of clinical data for use in NCI review and future reporting needs.
    2. The Data Quality Portal which provides a central location for sites and LPOs to generate and review delinquency data and queries allowing a more comprehensive site performance review.
    3. The Site Audit Report which provides a standard source data verification process including custom reports for auditor use and the ability to record audit results within Rave.
    4. The Rave/caAERS integration to allow a single point of entry for all adverse event data on Alliance trials.

Looking forward, a robust retirement plan for legacy data collection and redundant systems is in full swing, to be completed by the end of December 2017, specifically:

  • The core of the plan calls for active studies (patients on treatment / in follow-up) to migrate their data collection activities from Teleforms to Medidata Rave (first legacy trial converted from Teleforms to Rave in November 2014).
  • Data from the legacy data collection systems will reside in the Alliance data warehouse and will continue to be available to statisticians and reporting personnel.

Beginning in 2017, the Alliance SDC will undertake a major systems replacement initiative that is designed to replace its core study management and patient registration applications. This initiative is intended to improve user workflows, improve data quality, and to significantly reduce maintenance costs. The project is expected to have first deployments in Q2 2018.

The Alliance SDC is working very hard on being compliant with the Clinical Trials.gov reporting by the target date of April 2017. As of February 10, 2017, we have 54 trials reported, and 15 remaining to be reported. We are also working on the NCTN data sharing initiatives and the project data sphere data share initiatives. We are also actively working on a number of registration trials to be activated in 2017. These trials require a number of enhancements to our systems and data management infrastructure that the SDC is working to implement.

Finally, a statistical fellowship award in Innovative Clinical Trial Design and Methods in honor of Dan will be instituted, details of which will be forthcoming soon.

Thank you all for your support, cooperation, trust and patience the last few months as I transitioned into this role, and for everything you do to make our Group the success that it is.


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