E-Newsletter - November 2015

Introducing Alliance Foundation Trials, LLC (AFT)

Alliance Foundation Trials, LLC (AFT) is a research organization that develops and conducts cancer clinical trials, working closely with pharmaceutical partners, research collaborators and the Alliance for Clinical Trials in Oncology scientific investigators and institutional member network.  AFT seeks to fulfill the vision of the Alliance for Clinical Trials in Oncology to reduce the impact of cancer on people by uniting a broad community of scientists and clinicians from many disciplines committed to discovering, validating and disseminating effective strategies for the prevention and treatment of cancer.

Established in 2014 as a limited liability corporation, AFT is managed by the Alliance for Clinical Trials in Oncology Foundation, which is its sole member. The AFT operational structure and funding sources are separate from the Alliance clinical trials program funded by the National Cancer Institute (NCI).

AFT offers clinical trial investigators, pharmaceutical partners and the Alliance for Clinical Trials in Oncology institutional member network collaborative opportunities to develop and conduct trials, in addition to NCI-funded initiatives. This expands access and trial design options. AFT studies are developed by the Alliance scientific committees and are integrated into scientific goals of the committees.

Sites eligible to participate in AFT trials are members of the Alliance for Clinical Trials in Oncology network in good standing. AFT determines site-protocol matches based on previous site performance, accrual reports and results from its feasibility process. AFT invites sites that meet these criteria to participate in trials.




AFT sponsor

 Pharmaceutical collaborator sponsor

AFT holds IND

 Pharmaceutical collaborator holds IND (regulatory)

AFT responsible for entire conduct of the study

 Pharmaceutical collaborator responsible
 for entire conduct of the study

Site contracts are with AFT

 Site contracting responsibilities determined per
 agreement with collaborators

Pharmaceutical collaborator shares in study development; provides funding, drug supply and distribution and data submission for regulatory approval (registration trials)

AFT responsible for AFT site selection and site performance monitoring, assists with patient recruitment efforts at minimum; other functions are per  agreement with collaborators

Site Identification


Overall good standing as Alliance member

AFT reviews previous site performance and accrual reports to determine site selection in general

AFT conducts feasibility process to assess site’s capability to conduct trial based on specific protocol requirements

AFT invites site to participate


Difference Between AFT and Alliance Trials



Study Selection and Development

Study design by Alliance scientific and modality committees

Study design by Alliance scientific and modality committees

Studies available by invitation

Studies available through CTSU menu

Studies open to invited sites

Studies open to Alliance and NCTN members

Site Selection

Studies limited to selected sites with network

Generally, studies open to all components of network

# of sites limited based on study and funding

# of sites within member network may be limited; entire network, including affiliates may not be invited

Operations Systems and Partners

Separate Interactive Response Technology (IRT for patient registration), Clinical Trial Management System (CTMS), AFT Medidata RAVE electronic data capture, Argus Safety System (expedited adverse event reporting), electronic Trial Master File (eTMF), AFT Biospecimen Management System

  • CTSU Oncology Patient Enrollment
  • Alliance Medidata Rave electronic data capture
  • CTSU Regulatory Support System
  • Alliance BioMS (biospecimen management system)

Central Institutional Board Review (CIRB) (Quorum or other CIRB)

  • NCI Central Institutional Board Review (CIRB)

Mayo Clinic Statistics and Data Center

  • Mayo Clinic Statistics and Data Center

Biorepository at Washington University


  • Biorepositories at Washington University, Mayo Clinic, Ohio State University

Contracts and Funding

Master Services Agreement or Clinical Trial Agreement

  • Agreements through Brigham and Women’s Hospital
  • Purchasing Service Agreement (PSA) allows per case funding from NCTN grants
  • Agreements with Mayo Clinic allows per case funding through NCORP grants

Negotiated budget (study, patient case reimbursement, administrative site costs)

  • Standard NCI per case payment, and additionalpayments per study funding sheet

Per case payment for patients and accrual and pass through costs

  • Agreements with Mayo Clinic – case reimbursements through NCORP grants

Alliance Membership Accrual

One patient intervention accrual credit toward Alliance membership recorded after network has met 15 patient treatment/intervention accruals per year (cannot use AFT accruals to make up Alliance deficiency – e.g., 15 Alliance accruals + 10 AFT accruals = 25 Alliance membership accruals; however, 10 Alliance accruals + 10 AFT accruals = 10 Alliance membership accruals)

  • 15 patient treatment/intervention accruals per  network/per year
  • 5 patient treatment/intervention accruals per affiliate/per year


Monica M. Bertagnolli, MD
Chief Executive Officer

Gini F. Fleming, MD
Chief Scientific Officer


Suzanne George, MD
Dana-Farber Cancer Institute

Olwen M. Hahn, MD
University of Chicago
Comprehensive Cancer Center

Elise Horvath, MD
Alliance for Clinical Trials
in Oncology Foundation

David Kozono, MD, PhD
Dana-Farber Cancer Institute

Otto Metzger, MD
Dana-Farber Cancer Institute

Scott E. Smith, MD, PhD
Loyola University Medical Center


Trini Ajazi, MM

Chief Administrator Officer

Drew Gollerkeri, MBA

Sylvia Hrbek
Accounting Manager

Purcella Jennings
Accounting Manager

Jennifer Gaskin, CCRP
Operations Director

Michelle Pucillo, MPH
Operations Director

Erin M. Mueller, MA
Director, Contracts and Agreements

Carter DuFrane
Senior Project Manager

Aimee Farrell
Senior Project Manager

Emma McCarthy
Project Manager

Alicia Quirke
Site Manager

Laura Hatcher
Senior Clinical Research Associate

Hillary Wilson
Clinical Research Associate

Mary MacDonald
Project Coordinator - Quality Assurance


To learn more about AFT, visit www.AllianceFoundationTrials.org.


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