Use of hybrid operations to promote equity (HOPE) and enhance access to oncology treatment trials.

128 Background: Oncology treatment trial conduct is often limited to academic medical centers (AMCs) distantly located from the patients they serve. Legal and contractual barriers often preclude AMCs from opening clinical trials at community sites and those sites may lack robust onsite clinical research infrastructure. Limiting clinical trials to the main AMC creates barriers to patient participation including logistical challenges such as travel, missed work, financial stress, and loss of access to local resources designed to support patient needs (e.g., transportation, on-site meals, trusted provider relationships, local cultural, linguistic, and educational resources). AMCs need to partner with local healthcare providers (HCPs) to design innovative solutions to bring clinical trials closer to patients without adding undue burden on community sites. Methods: UNC Lineberger, in collaboration with local HCPs working across North Carolina, developed and implemented hybrid decentralized clinical trial (DCT) infrastructure and methodologies. The emphasis was on facilitating protocol-mandated assessments and visits to be conducted by local HCPs, who are not considered "engaged in research" per the regulatory definition and do not need to be formally associated with UNC Lineberger via legal research agreements. HARMONY (NCT03769415), an interventional treatment study designed to determine the impact of molecular information on clinical decision-making in metastatic breast cancer, was chosen for pilot testing as a hybrid DCT due to straightforward design, relevant research questions, and expressed interest from community providers. Results: HARMONY was amended for hybrid DCT methodologies with specific adaptations to account for local biospecimen collection, remote screening of local HCP schedules, collaboration with local HCPs on introducing the study, remote consent, and returning of molecular results to local HCPs. This pilot was successfully operationalized with limited administrative burden to local providers and the enrollment of 20 local HCP patients over a 1-year period in comparison to 23 at the AMC. Compliance analysis showed high protocol adherence with only 2 deviations associated with the patients enrolled from a remote site. Conclusions: Pilot trial success indicates that AMCs can successfully partner with local HCPs to operationalize hybrid decentralized oncology treatment trials moving most, if not all, assessments closer to patient homes without overburdening community sites or incurring non-compliance. This work addresses questions raised by an American Society of Clinical Oncology (ASCO) taskforce regarding application of such a design to oncology clinical research, and stressing the need to amend and formalize procedures to compliantly conduct such studies. Clinical trial information: NCT03769415 .