distinction between “Phase 2 Tx Studies” and “Phase 2 Combination Tx Studies”. clinical studies. “Phase 2 Combination Tx Studies” refers to Phase 2 toxicity clinical studies with combination regimes of two or more study agents. Table 5: Should all LAO studies be listed or should all studies conducted by the site PI? This table should list all high priority studies at all sites involved in the research project (LAO, IC and AO, as applicable). The purpose of this table is to define the capacity and ability of the LAO, IC and AO (as applicable) to conduct early phase experimental therapeutic studies. Table 5: We do not routinely collect screening data from outside institutions on patients who were not registered on the trial. We can obtain the number of patients who signed consent at the LAO (but not the number who were considered for a trial and excluded based on information obtained for routine clinical management not requiring consent). We may be able to obtain accurate information from the AOs. However, it is unlikely that we can obtain accurate information after the fact from other participating sites for multi-site studies which we coordinated. Provide what you have. We are specifically looking for patients that were screened and were found to be ineligible, for example patients were screened to see if they had a particular biomarker and most were found ineligible because they did not have that particular biomarker. Table 6: What is meant by these two columns – “Accrual to Trial led by Applicant” and “Accrual to Trial NOT lead by “Accrual to Trial Led by Applicant” means clinical trials where the proposed LAO, IC or AO investigators on the application are/were the lead PI on the clinical trial protocol. “Accrual to Trial NOT led by Applicant” means clinical trials where an
Reported” and “# of Specimens Analyzed?” is the number of specimens actually used for some sort of testing, assay, diagnostic, or characterization. Table 11: Are the SOPs requested for the LAO only or for AOs as well? All that is required is a list with only the name of the SOPs for the LAO and AOs. If the LAO and AO share the same SOP, it only needs to be listed once. We do not want copies of the SOPs. Tables 2-10: is the expectation to include data for all applicable clinical trials conducted at our institution or only clinical trials in which the ET-CTN investigators participated? The primary purpose of the resources tables is to document the PI’s and site(s)’s ability to effectively conduct early phase clinical trials. It should clearly convey the investigators ability to accomplish the goals and objectives of the study. The applicant should use his/her best judgment as to which studies are included. Can non-CTEP trials (e.g. pharmaceutical trials) be included in any of the tables that fit in the phase ½ category? Yes, pharmaceutical trials can be included. Pharmaceutical trials should be clearly labeled. If a study opened in 2006 and accrued until it was closed in 2009, how would the information be reported on the tables? Would the accrual and samples only be reported from 2008-2009? Accrual information is placed in the table in the year the study was closed or completed. RFA/FOA Is this RFA considering new awards or is it only going to re-fund existing awards? This RFA will fund new awards.