distinction between “Phase 2 clinical studies. “Phase 2 Combination Tx Studies” refers to Tx Studies” and “Phase 2 Phase 2 toxicity clinical studies with combination regimes of Combination Tx Studies”. two or more study agents. Table 5: Should all LAO This table should list all high priority studies at all sites involved studies be listed or should all in the research project (LAO, IC and AO, as applicable). The studies conducted by the site purpose of this table is to define the capacity and ability of the PI? LAO, IC and AO (as applicable) to conduct early phase experimental therapeutic studies. Table 5: We do not routinely Provide what you have. We are specifically looking for patients collect screening data from that were screened and were found to be ineligible, for outside institutions on example patients were screened to see if they had a particular patients who were not biomarker and most were found ineligible because they did registered on the trial. We not have that particular biomarker. 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. Table 6: What is meant by “Accrual to Trial Led by Applicant” means clinical trials where these two columns – “Accrual the proposed LAO, IC or AO investigators on the application to Trial led by Applicant” and are/were the lead PI on the clinical trial protocol. “Accrual to “Accrual to Trial NOT lead by Trial NOT led by Applicant” means clinical trials where an
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
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