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LECTURE 04 2011 - Outline of Randomization Lectures 1...

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Outline of Randomization Lectures 1. Background and definitions 2. Generation of schedules 3. Implementation (to ensure allocation concealment, sometimes called blinded randomization) 4. Theory behind randomization
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Randomization Schedule A list showing the order in which subjects are to be assigned to the various treatment groups
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Implementation Schemes 1. Sealed envelopes - Opaque - Sequentially numbered 2. Telephone - Answering service - Coordinating center - IVRS 3. Personal computers - Local - Through communication with coordinating center 4. International coordinating centers in HIV treatment trials telnet to central coordinating center
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Urokinase-Pulmonary Embolism Trial (UPET) Circulation , 1973 1. Telephone answering service in New York City; 24-hour coverage 2. Assignments obtained through hospital pharmacy 3.Sealed envelopes as back-up
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Multiple Risk Factor Intervention Trial (MRFIT) JAMA , 1982 1. Assignments obtained by calling coordinating center after: a. Three screening visits b. Informed consent c. Eligibility checklist 2. Sealed envelopes used as back-up
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Treatment of Mild Hypertension Study (TOHMS) 1. Assignment (bottle no.) obtained using personal computer to call coordinating center computer after: a. Three screening visits b. Informed consent c. Eligibility checklist 2. Call coordinating center for back-up 3. Unique bottle no. for each participant 4. Bottle no. not assigned in sequence Amer J Cardiol , 1987
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Community Programs for Clinical Research on AIDS (CPCRA) 1. Assignments obtained by calling Statistical Center: Minimal data collection Usually no data at Statistical Center prior to randomization Eligibility checklist reviewed on telephone call 2. Pharmacist telephones to confirm assignment 3. Unique study ID number (SID) for each patient 4. SID numbers not assigned in sequence
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Components of CPCRA Randomization System 1. Randomization schedule, based on randomly permuted blocks 2. SID numbers, sheets, and notebooks 3. Randomization logbooks 4. Eligibility checking program 5. Pharmacy checking program 6. Backup procedures 7. Training (local and for clinical sites)
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C ontrolled On set V erapamil In vestigation of C ardiovascular E ndpoints (CONVINCE) Interactive Voice Response System (IVRS) Touch-tone keypad used for data entry of key eligibility data System verifies eligibility and assigns medication code (bottle number) Caller re-enters medication code as a double-check System also used for medication refills
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Survey of 15 Major Cancer Centers for Methods of Randomization Preparation of Schedules Permuted block* 13 Other 2 Computer 7 Random no. table 8 *Most common block size = 2 x no. treatments Mechanics of Treatment Assignment Telephone 12 Sealed envelopes 3 Source: Pocock et al., Br J Cancer , 1982
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