treatment will be delivered, how it will target cancerous cells, how it will be released into the cell, what it will do once inside the cell, and how it will destroy the cell. Use your notes in your laboratory journal to get ideas. Document your design in your laboratory journal. You and your partner are the lead researchers in charge of developing the nanotechnology-based treatment designed in the previous step. You have had positive results with both in vitro testing (involving cell culture) and in vivo testing (involving laboratory animals). Develop a clinical trial to test the safety and efficacy of your treatment. Refer to the notes in your laboratory journal from Activity 3.4.3 Clinical Trials to review the set up of a clinical trial. With your group, you will present your clinical trial proposal to the class, who will act as the Institutional Review Board. the following information in your presentation: Background Information: Name of clinical trial Description of population being studied Summary of the known and potential risks and benefits, if any, to human subjects Description of the route of administration (delivery method) Description of the cells the treatment will target Description of how the treatment will target these cells Description of how the treatment will be released into the targeted cells Description of what the treatment will do once inside the targeted cells Description of how the treatment will destroy the targeted cells Trial Objectives and Purpose: Description of the goals of the trial Description of the hypothesis of the results of the trial Description of how this treatment will be better than the treatments that are currently being used for this type of cancer Trial Design: Description of the type/design of trial to be conducted (e.g., double-blind, placebo-controlled) and a schematic diagram of the trial design Selection of Subjects: Specification of the criteria for the inclusion and exclusion of potential subjects (i.e. who is eligible to participate in the study and who is not) Assessment of Safety: Description of safety procedures a presentation that lasts no longer than 10 minutes. Use presentation software to create the framework for your presentation. Think about all that goes into completing a clinical trial. Be thorough and creative. Cover all of the bases so your trial is approved by the IRB board.
treatment will be delivered, how it will target cancerous cells, how it will be released into the cell, what it will do once inside the cell, and how it will destroy the cell. Use your notes in your laboratory journal to get ideas. Document your design in your laboratory journal. You and your partner are the lead researchers in charge of developing the nanotechnology-based treatment designed in the previous step. You have had positive results with both in vitro testing (involving cell culture) and in vivo testing (involving laboratory animals). Develop a clinical trial to test the safety and efficacy of your treatment. Refer to the notes in your laboratory journal from Activity 3.4.3 Clinical Trials to review the set up of a clinical trial. With your group, you will present your clinical trial proposal to the class, who will act as the Institutional Review Board. the following information in your presentation: Background Information: Name of clinical trial Description of population being studied Summary of the known and potential risks and benefits, if any, to human subjects Description of the route of administration (delivery method) Description of the cells the treatment will target Description of how the treatment will target these cells Description of how the treatment will be released into the targeted cells Description of what the treatment will do once inside the targeted cells Description of how the treatment will destroy the targeted cells Trial Objectives and Purpose: Description of the goals of the trial Description of the hypothesis of the results of the trial Description of how this treatment will be better than the treatments that are currently being used for this type of cancer Trial Design: Description of the type/design of trial to be conducted (e.g., double-blind, placebo-controlled) and a schematic diagram of the trial design Selection of Subjects: Specification of the criteria for the inclusion and exclusion of potential subjects (i.e. who is eligible to participate in the study and who is not) Assessment of Safety: Description of safety procedures a presentation that lasts no longer than 10 minutes. Use presentation software to create the framework for your presentation. Think about all that goes into completing a clinical trial. Be thorough and creative. Cover all of the bases so your trial is approved by the IRB board.