E-Newsletter - April 2018

Revisiting the Alliance Conflict of Interest Policy

The Alliance for Clinical Trials in Oncology revised and re-released its Policies and Procedures document in December 2017, with an effective date of January 1, 2018. The changes reflect the current NCI Clinical Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP) infrastructure, policies and procedures, as well as clarifications or changes in Alliance practices that have been implemented.

Specifically, the Alliance Conflict of Interest Policy (Section 3.5) was updated to include collection and review of study-specific COI disclosures from institutional investigators, in addition to the main member Principal Investigator. It is important to note that study-specific COI disclosures may be collected on select studies. The COI policy was updated to implement additional review considerations determined by the Alliance COI Committee related to disclosures from Alliance leadership. These considerations include multiple disclosures that individually do not meet thresholds set forth in the current policy. Multiple disclosures of greater than $5,000 are subject to review by the Alliance COI Committee. The committee may request a management plan including oversight by co-leaders. The policy was also updated to strengthen the language regarding public disclosure of potential COI. 

Defining Financial Conflict of Interest

According to the Alliance P&P (Section, a financial conflict of interest (FCOI) in research means significant financial interest that could directly and significantly affect the design, conduct, analysis or reporting of research. For Alliance for Clinical Trials in Oncology, each person proposed to hold a leadership or staff role that impacts the design, conduct, analysis or reporting of research results must comply with financial disclosure requirements. The Alliance study chairs/co-chairs, committee chairs, group leaders, Data and Safety Monitoring Board, institutional investigators and Alliance operations staff members are required to disclose financial arrangements >$5,000 per year, as defined in this policy. FCOI training, review of the Alliance Conflict of Interest Policy and submission of the Alliance COI form must be completed prior to research participation and at least annually. Updated COI forms are required to be submitted within 30 days of a change in financial arrangements. Study specific COI forms must be submitted until study results are published. Alliance training on the COI Policy and other educational materials will be provided during the annual Alliance Group meeting.

Take a few minutes to read and review the Alliance Conflict of Interest Policy, and ensure that you’re in full compliance. For more information or questions about the policy, contact Leslie Kelley, Alliance Regulatory Compliance Manager, by e-mail Regulatory@AllianceNCTN.org.

About the Alliance Conflict of Interest Committee
The Alliance Conflict of Interest Committee is a volunteer committee comprised of Alliance investigators. The committee reviews financial conflict of interest disclosures related to trials supported by the Alliance and Alliance for Clinical Trials in Oncology Foundation.



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