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. 2020 Aug 4;9(4):522–527. doi: 10.1089/jayao.2019.0139

Table 1.

Roles of the Adolescent and Young Adult Responsible Investigator

Role Examples
1. Address regulatory issues Work with research office and IRB to
advocate for opening AYA trials
Assist medical oncology research offices with navigating cross-enrollment process
Ensure adherence with study procedures and reporting of adverse events for AYA cross-enrollments
2. Enhance screening and recruitment processes Utilize systematic screening processes to identify and target AYA patients for recruitment to front-line, retrieval, and non-therapeutic studies
Establish cross-service screening processes with medical oncology to address full AYA age spectrum
Designate consistent clinical or research staff member to lead screening efforts (e.g., nurse or clinical research associate)
Initiate cross-service email notifications of newly diagnosed AYAs and potentially applicable studies
3. Facilitate collaboration between pediatric and medical oncology Address common barriers to collaboration
Identify and open available AYA eligible trials
Form partnerships to identify and recruit AYAs eligible for COG and other NCTN trials
Ensure adherence with protocol requirements
Facilitate COG membership for medical oncology
Form COG-SWOG dyad for COG AYA RI Network, if applicable
Establish joint tumor boards, where applicable
4. Serve as the institutional AYA-focused communication link with COG, including the AYA RI Network Provide site-level feedback for active and proposed COG studies
Serve as the recipient of COG accrual updates, newsletters, and surveys
Share site-level information on local enrollment challenges and solutions
Participate in COG AYA RI Network webinars
5. Raise local awareness and educate regarding AYA clinical trial enrollment disparities Track local AYA enrollments
Share local AYA enrollment figures with medical oncology, nursing, CRAs
Present at grand rounds, seminars, tumor boards
Educate staff on strategies to overcome barriers to enrollment
Disseminate information from AYA RI Network webinars

AYA, adolescents and young adult; COG, Children's Oncology Group; CRAs, clinical research associates; IRB, Institutional Review Board; NCTN, National Clinical Trials Network; RI, Responsible Investigator; SWOG, SWOG Cancer Research Network.