Accelerating RTOR in Oncology: The AIM Model for Agile Trial Operations
Author(s)
Jigar Prajapati, M.Sc.1, VATSAL CHHAYA, M.Sc.1, Shaurya Deep Bajwa, M.Sc, MBA2, KAPIL KHAMBHOLJA, PhD1.
1Catalyst Clinical Research, Baroda, India, 2Catalyst Clinical Research, Thiruvananthapuram, India.
1Catalyst Clinical Research, Baroda, India, 2Catalyst Clinical Research, Thiruvananthapuram, India.
OBJECTIVES: The FDA’s Real-Time Oncology Review (RTOR) pathway accelerates cancer therapy access through early data submission and iterative review processes. Yet, manual and fragmented oncology trial workflows often impede RTOR readiness. We propose AIM—Automate, Integrate, Monitor a framework using automation to cut manual tasks, cross-functional integration to break silos, and real-time monitoring of trial progress, data locks, and submissions. AIM enhances operational efficiency, regulatory alignment, and patient access speed in oncology.
METHODS: The AIM model was developed using a concept-driven approach. A review of relevant literature was conducted to understand the current landscape of automation technologies, integration strategies, and operations insufficiencies in oncology trials. Expert insights from clinical operations, regulatory affairs, and digital innovation teams were synthesized to identify common barriers to workflow agility and submission readiness. These insights informed the design of the AIM framework which was reviewed for clarity, scalability, and regulatory readiness.
RESULTS: The AIM model identifies three key components for operationalizing RTOR in oncology trials:
1. Automate- Leverage digital tools to reduce manual tasks, improve data accuracy, and streamline workflows.
2. Integrate- Promote cross-functional coordination across clinical, regulatory, and digital innovation teams to reduce silos.
3. Monitor- Enable real-time tracking of trial progress, data lock status, and submission milestones. Collectively, these components offer a structured approach to improve operational efficiency, ensure regulatory readiness, and align with RTOR’s accelerated timelines. The model also highlights key focus areas where future investment in automation and integration may yield better gains.
CONCLUSIONS: The AIM framework offers a structured, scalable model to embed automation, integration, and real-time monitoring into clinical trials. By reducing manual burdens, enhancing coordination, and enabling real-time oversight, it supports sponsors in meeting RTOR’s expedited timelines and may facilitate faster patient access to oncology innovations.
METHODS: The AIM model was developed using a concept-driven approach. A review of relevant literature was conducted to understand the current landscape of automation technologies, integration strategies, and operations insufficiencies in oncology trials. Expert insights from clinical operations, regulatory affairs, and digital innovation teams were synthesized to identify common barriers to workflow agility and submission readiness. These insights informed the design of the AIM framework which was reviewed for clarity, scalability, and regulatory readiness.
RESULTS: The AIM model identifies three key components for operationalizing RTOR in oncology trials:
1. Automate- Leverage digital tools to reduce manual tasks, improve data accuracy, and streamline workflows.
2. Integrate- Promote cross-functional coordination across clinical, regulatory, and digital innovation teams to reduce silos.
3. Monitor- Enable real-time tracking of trial progress, data lock status, and submission milestones. Collectively, these components offer a structured approach to improve operational efficiency, ensure regulatory readiness, and align with RTOR’s accelerated timelines. The model also highlights key focus areas where future investment in automation and integration may yield better gains.
CONCLUSIONS: The AIM framework offers a structured, scalable model to embed automation, integration, and real-time monitoring into clinical trials. By reducing manual burdens, enhancing coordination, and enabling real-time oversight, it supports sponsors in meeting RTOR’s expedited timelines and may facilitate faster patient access to oncology innovations.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR11
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
Oncology