Use the resources provided to answer the questions in each area. Sample Phase 1 Oncology Protocol 1. This, as you have now learned, is a pretty typical phase one trial, with the exception that it has two parts. It could be two separate protocols, but it makes sense to combine these protocols together into a single PK study. 2. How do the Parts A and B objectives differ? Does it make sense to place these mini-trials in the same study? Part A strives to characterize the PK parameters while Part B strives to establish MTD. While I understand why these are in the same study, I would prefer their separation. 3. What are the basic entry criteria? 4. What are the DLT rules? 5. Why is the generic paclitaxel label referenced in this trial? 6. Why would treating cancer with carboplatin (an alkylating agent) and paclotaxel (a microtubule polymerization enhancer) possibly be a good chemotherapy regimen? What would the disadvantages be? 7. Are drugs often combined in oncology treatment (to make a regimen)? Three examples of combination oncology regimens are., …., and ..? 8. In this trial, for cycles 3 and later why is DLT assessment not required ? 9. Why are dose modifications allowed in this study? 10. Why is the use of G-CSF prohibited until Cycle 2? 11. Is an advanced lymphoma patient allowed to enter this trial? Why? 12. What will be the most common reason for exiting the trial in these types of phase 1 studies? 13. Google the handling and administering of chemotherapy agents. Are there specific guidelines for handling chemotherapy agents? What do they entail? Is there a governing agency for the guidelines? 14. How is efficacy measured in this phase 1 trial? Is this a well known methodology? 15. Which AE cataloging/categorizing system is used in this trial? Is the use of this method common in oncology trials? 16. What is the procedure for reporting unexpected, serious, and drug-related events? Is this procedure mentioned in this trial? Simon et al Accelerated Dosing in Phase 1 1. What are the basic differences in Simons study Designs 1 through 4? 2. How many simulated sets of data were examined? How many actual phase 1 trials were studied? 3. Did the design type (1-4) affect the ability to determine MTD in a reasonable amount of time? 4. How did average number of subjects needed to complete the trial differ among design groups? 5. How did average number of cohorts differ among design groups? 6. How did number of subjects in toxicity grades 1-4 vary among the 4 trial designs? 7. What objectives were accomplished by this research group (Simon, et al) following their experimentation with phase 1 trial design? 8. Undertreated subjects is a problem in typical phase 1 trials. Which trial designs had fewer undertreated subjects? ICH Guidance GCP 1. What are three of the most important principles of GCP? 2. What is the least amount of members for an IRB? 3. What qualifies an investigator for participation in a clinical trial? 4. When should an Informed Consent be revised? 5. Who can terminate a study? 6. Prior to signing a contract with an investigator, what should the Sponsor do? 7. What is the purpose of monitoring? 8. What is the purpose of auditing a clinic participating in a trial? 9. What are 4 documents an investigator must have available for review prior to allowing she/he to conduct a trial? Choice for Control Group 1. How does the choice of a control group affect the success of a trial? 2. What is the single major purpose of a control group? 3. Is double-blinding always possible in a trial? 4. Can the selection of subject population affect the outcome of a study? 5. List 4 factors that may reduce the ability to detect a difference between two treatments? 6. How can bias be minimized? 7. What are three important advantages of the placebo-controlled trial? Data Monitoring Committees Guidance 1. What is the simple purpose of a DMC? 2. Why were DMCs invented in the early 1960s? 3. When are DMCs recommended? not recommended? 4. Which types of professionals are needed to form a DMC? 5. May investigators participating in the trial become DMC members? Why or why not? 6. Why is the establishment of a charter EXTREMELY important when creating a DMC? 7. What is one (or perhaps the only) major responsibility of a DMC? 8. Does the DMC monitor both safety and efficacy? Why? 9. If the DMC has safety concerns regarding an ongoing trial they may stop the trial or modify in what way(s)? 10. Many Sponsors ask the DMC to take a statistical (unblinded) look at the data collected thus far (in other words: analyze the data available [usually halfway through the trial] and see if the data statistics are consistent with what was expected for the primary efficacy endpoint, for example)? Is this allowed (can you really take a peak)? Why can this be allowed? Expedited Reporting of Safety Information 1. What was the reason for creating this document, since the FDA and the ICH already define expected, serious adverse effect, and drug-related in various other documents? 2. A subject has just given informed, written consent to participate in your trial. He is in the process of completing the assays and procedures needed at screening. He walks from one building of your hospital to another and trips and sprains his ankle. Is this an AE? Where do you report this event? 3. What is a SUSAR? What is the difference between a SUSAR and an adverse event? 4. Can the investigator determine if the serious and possibly drug related (according to the investigator) event is expected? Why or why not? 5. Does the FDA really think that the Sponsor will update the IB often enough to contain a complete listing of all AEs? So what does the Sponsor do? 6. What are the time deadlines for expedited reporting of SUSARS?
https://customessayusa.com/wp-content/uploads/2021/07/customlogo-300x60.png 0 0 https://customessayusa.com/wp-content/uploads/2021/07/customlogo-300x60.png 2022-05-07 18:34:282022-05-07 18:34:28What was the reason for creating this document, since the FDA and the ICH already define expected, serious adverse effect, and drug-related in various other documents?
GET TO NOW US
Thousands of students and professionals rely on us for their writing tasks to achieve their goals in academic life. Our services are offered as a fusion of quality, affordability, reliability, and utmost dedication.
We accept major payment methods