ST 520 Statistical Principles of Clinical Trials - NCSU Statistics ...

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CHAPTER 4 ST 520, A. TSIATIS and D. Zhang • Clinician is willing to accept randomization • Patient consent is obtained. In the US this is a legal requirement • Patient formally entered into the trial After a patient and his/her physician agree to participate in the trial then • Each patient must be formally identified. This can be done by collecting some minimal information; i.e. name, date of birth, hospital number. This information should be kept on a log (perhaps at a central office) and given a trial ID number for future identification. This helps keep track of the patient and it helps guard against investigators not giving the allocated treatment. • The treatment assignment is obtained from a randomization list. Most often prepared in advance (a) The randomization list could be transferred to a sequence of sealed envelopes each containing the name of the next treatment on the card. The clinician opens the envelope when a patient has been formerly registered onto the trial (b) If the trial is double-blind then the pharmacist preparing the drugs needs to be in- volved. They prepare the sequence of drug packages according to the randomization list. (c) For a multi-center trial, randomization is carried out by the central office by phone or by computer. (d) For a double-blind multi-center trial, the randomization may need to be decentralized Documentation to each center according to (b). However, central registration is recommended. • A confirmation form needs to be filled out after treatment assignment which contains name, trial number and assigned treatment. If randomization is centralized then this confirmation form gets sent from the central office to the physician. If it is decentralized then it goes from physician to central office. PAGE 72
CHAPTER 4 ST 520, A. TSIATIS and D. Zhang • An on-study form is then filled out containing all relevant information prior to treatment such as previous therapies, personal characteristics (age, race, gender, etc.), details about clinical conditions and certain laboratory tests (e.g. lung function for respiratory illness) All of these checks and balances must take place quickly but accurately prior to the patient commencing therapy. PAGE 73
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ST 520 Statistical Principles of Cl
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TABLE OF CONTENTS ST 520, A. Tsiati
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CHAPTER 1 ST 520, A. TSIATIS and D.
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CHAPTER 10 ST 520, A. TSIATIS and D
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ST 520 Statistical Principles of Clinical Trials - NCSU Statistics ...

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