Photo Courtesy of ARPA-H

ADvanced Analysis for Precision cancer Therapy (ADAPT)

The CX Hub has released a survey in support of ARPA-H’s program for ADvanced Analysis for Precision cancer Therapy. Specifically, ARPA-H is looking for CRO services to support a single evolutionary clinical trial that will enroll patients with metastatic breast, lung, and colon cancers. This trial will adjust drug treatments based on tumor evolution during multiple sequences of therapy. The CRO service will establish and coordinate clinical trial efforts across multiple ADAPT performers in different geographical locations, allowing for clinical interventions and tumor biology assessments in real time.

The ADAPT program seeks a CRO capable of providing the following services in its Program Phase 1 Stage I: Regulatory affairs and complianceclinical trial planningclinical trial protocol management, clinical trial site identification and selectionclinical trial site initiation and activationand patient recruitment.

In Program Phase I Stage II and Phase II, the program seeks CRO support for: patient recruitment and retention, patient enrollment (target of 2000 patients across 8+ trial sites, with demographics representative of the cancer types investigated in ADAPT- breast, colon, and lung cancers), clinical trial site management, clinical monitoring, drug logistics, drug safety management, biomarker testing, biomarker integration, biological sample collection and processing including but not limited to patient blood and tumor biopsies, biological sample distribution including but not limited to transfer of patient blood and tumor biopsies to testing labs, data management, data auditing, regulatory requirements and compliance, study file and document management, quality control, communication with trial sponsors, site closeout, transfer of clinical trial data to the ADAPT program performers.

In addition to the above activities, the ADAPT program is interested in the CRO’s historical patient population data including demographics from trials performed at the respondent organization in the past 2 years, stratified by cancer type (breast, lung, colon).

The ADAPT program is also interested in the CRO’s capabilities surrounding innovative trial initiation and management. To support this interest, please complete the survey here. This survey closes on June 4, 2024. The CX Hub and ARPA-H deeply value your input and look forward to reviewing your responses. 

Organizations or institutions interested in becoming a part of the CX Hub Spoke network can learn more at the How to Join webpage.