Trial Design Support

IROC trial design support facilitates research protocols with clearly written specifications and requirements, enabling efficient data collection and robust analysis.

To promote quality in NCI-sponsored clinical trials with imaging and radiotherapy (RT) endpoints, IROC QA personnel provide support at every stage of research design and protocol development. From standard-of-care guidelines to novel techniques and modalities for imaging and RT, IROC offers services to match the research project’s unique needs.

These services include:

• Advice for investigators on appropriate modalities, techniques, and associated QA-related issues.
• Efficient and timely communication within the NCTN via email, web conferences, teleconferences, and face-to-face meetings.
• A multifaceted approach for RT facilities that tailors QA processes based on the complexity of a clinical trial.
• Recommendations for image review type (local vs. central) or timing (real-time vs. retrospective) for a given trial, along with identification of appropriate reader services.
• Recommendations for RT case review (pre-, on-, and post-treatment implementation).
• Support for the development of protocol sections pertaining to proper image acquisition and RT techniques, with corresponding QA processes.
• Resources focused on the timely development of accurate protocol content, including:
  • Questionnaires to efficiently gather information to aid QA recommendations.
  • Imaging manuals or charters with step-by-step guidance.
  • A complete library of templates to accelerate completion of the QA protocol components.

IROC’s trial design support facilitates research protocols with clearly written imaging and RT specifications and QA requirements, resulting in efficient data collection and robust analysis.