Trial Conduct Can samples be characterized Yes in a non-CLIA laboratory for patients not on treatment? Does an Investigational An IDE may not be needed for all integral biomarker assays. Device Exemption have to be But, if an IDE is required, the NCI Regulatory Affairs Branch in submitted for integral CTEP will provide regulatory assistance to the institution. The biomarker assays? NCI will also assist in submissions to the Food and Drug Administration. Are there standard Case Yes. NCI has, through its monitoring and auditing contractor Report Forms that must be Theradex, 150 standardized Case Report Forms. Included in the utilized for studies under the 150 Case Report Forms is a standardized Case Report Form for FOA? molecular characterization. What should be included in It is important to address outreach and accrual efforts at each the application when site. Of particular interest is the accrual of minorities and those addressing accrual? with rare diseases (if applicable). What criteria are there for The LAO should determine the best qualified investigator to selecting an LPO? conduct the clinical research project. (Note: Criteria for placement of NCI clinical studies have not changed). The LAO can select a young investigator with a mentor as principal investigator at an LPO. What are the criteria for The PTA is reviewed by the NCI program using a competitive selection of a submitted review process. Review criteria will include subject matter project team application expertise, existing NCI-funded, peer-reviewed projects, and (PTA)? ability to accrue patients. Sites will be notified if selected for the Drug X Project Team. How many PTAs will there be All PTAs submitted will be reviewed. The number selected to for any given drug that will be participate on a project team will be based on merit. approved? What is the role of the LPO? The LPO is the organization of the principal investigator of the protocol. Is the LPO the leader of the The LPO is the leader of the clinical trial. drug development plan, the clinical trial, or both?
Trial Conduct Can samples be characterized in a non-CLIA laboratory for patients not on treatment? Yes Does an Investigational Device Exemption have to be submitted for integral biomarker assays? An IDE may not be needed for all integral biomarker assays. But, if an IDE is required, the NCI Regulatory Affairs Branch in CTEP will provide regulatory assistance to the institution. The NCI will also assist in submissions to the Food and Drug Administration. Are there standard Case Report Forms that must be utilized for studies under the FOA? Yes. NCI has, through its monitoring and auditing contractor Theradex, 150 standardized Case Report Forms. Included in the 150 Case Report Forms is a standardized Case Report Form for molecular characterization. What should be included in the application when addressing accrual? It is important to address outreach and accrual efforts at each site. Of particular interest is the accrual of minorities and those with rare diseases (if applicable). What criteria are there for selecting an LPO? The LAO should determine the best qualified investigator to conduct the clinical research project. (Note: Criteria for placement of NCI clinical studies have not changed). The LAO can select a young investigator with a mentor as principal investigator at an LPO. What are the criteria for selection of a submitted project team application (PTA)? The PTA is reviewed by the NCI program using a competitive review process. Review criteria will include subject matter expertise, existing NCI-funded, peer-reviewed projects, and ability to accrue patients. Sites will be notified if selected for the Drug X Project Team. How many PTAs will there be for any given drug that will be approved? All PTAs submitted will be reviewed. The number selected to participate on a project team will be based on merit. What is the role of the LPO? The LPO is the organization of the principal investigator of the protocol. Is the LPO the leader of the drug development plan, the clinical trial, or both? The LPO is the leader of the clinical trial.