January 28 2021
The NRG New Investigators Committee Presents...
"LOI / Concept Development: Nuts & Bolts"
The Program Chair for this session and Head of Gynecologic Cancer Therapeutics at the Clinical Investigations Branch of the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP), Dr. Elise C. Kohn, MD started the presentations by thoroughly explaining the process of getting an idea or concept off the ground and into the form of a trial. Dr. Kohn explained the phases of trials, the pathways for NCI CTEP-supported trials, the process of trial reviews, and best practices including defining your study direction and parameters. She discussed the responsibilities of the task force and the Steering Committee and outlined the use of biomarkers in studies.
Dr. Charles Kunos of the Investigational Drug Brank of CTEP and the Division of Cancer Treatment & Diagnosis at the NCI, reviewed the CTEP portfolio, the NCI experimental therapeutics program (NExT) new drug application, the Experimental Therapeutics Clinical Trials Network (ETCTN) or the National Clinical Trials Network (NCTN), as well as early-phase trial Letter of Intents (LOI). Dr. Kunos made it a point to alert investigators that they should connect with CTEP and the Medical Officer as soon as they are aware that they wish to involve a IND agent on their trial so they are abreast on any information available that could be helpful during concept development.
Dr. Masha Kocherginsky of Northwestern University discussed statistical considerations for clinical trial design by highlighting the key components in designing a clinical trial, considerations for Phase II, III and II/III designs, and incorporating biomarkers into design. Dr. Kocherginsky reviewed phases, endpoint selection, treatment arm options, statistical concepts, interim analysis, the use of biomarkers, and multiple testing.
Nancy Soto, the Team Director of Protocol Development for NRG Oncology, reviewed the NRG-specific processes and requirements for LOIs and concept development, including the NRG internal review process involved in trial development to implementation. She outlined the role of the Principal investigator and the role of the Project Administrator in developing the trial as well as the communication that flows between these entities.
Lastly, Dr. Vinai Gondi, the Director of Research & Education at the Northwestern Medicine Proton Center, the Co-Director of Brain and Spine Tumor Center at the Northwestern Medicine Cancer Center, Warrenville, and the NRG New Investigator Brain Tumor New Investigator Liaison, told the story of his individual pathway to trial development through NRG Oncology. Dr. Gondi provided the timeline to LOI/protocol as well as his lessons learned including; thinking into the future, the value of mentorship, the need for innovation, the need to think like a disease leader, learning Steering Committee Priorities, emphasis on background and endpoints, welcoming feedback, acknowledging resources are finite, assembling your study team, prepare, be ready to beat any deadlines, enlist in other cooperative groups, and focus on your protocol's feasibility.
"NRG New Investigators Networking Luncheon"
New Investigators within NRG Oncology, mentors, investigators, NRG Committee leaders, and more were invited to attend a round-table style virtual networking event following the educational session on LOI and Concept Development. During this networking event, attendees joined the session and were triaged into a table to engage with other NRG stakeholders in their areas of interest, research efforts, discuss any questions, and solicit advice.