RandomizedControlledTrials随机临床试验.pptVIP

Lecture 6 * Lecture 6 * Lecture 6 * Lecture 6 * Lecture 14 * Cost-effectiveness analysis: cost, side effects, etc. Lecture 6 * Apply to the RCTs with long-term follow-up (loss to follow-up). Lecture 6 * AGE-STANDARDIZED DISTRIBUTION OF CHARACTERISTICS OF WOMEN PARTICIPATING IN THE NURSES’ HEALTH STUDY IN 1990, ACCORDING TO THE USE OR NONUSE OF POSTMENOPAUSAL HORMONES . Lecture 6 * Lecture 6 * Single Institution vs. Multiple Site Collaborative Controlled Trials Multi-center trials can be beneficial when: Generalization is important Limited number of patients are available from a single clinic We wish to bring together expertise However, multi-center trials add a significant amount of overhead to a study. / /ictrp/en/ https://www.clinicaltrialsregister.eu/index.html Registration of Clinical Trials Data Collection in RCTs Prognostic profile at entry Treatment Outcome Criteria for outcome, data management, and acquisition must explicit and written out. Data Collection – Treatment Data Assigned: The treatment arm/group that the subject was allocated to (placebo or active). Treatment A, Treatment B, or Treatment C Received: The actual treatment that the participant received. During the study, the investigators must assess compliance to the treatment Interview/ specimen collection Outcome Data Look for “improvement”, i.e. the desired effect Also must record any and all “side effects” Beneficial Harmful SAEs (severe adverse events) Intention To Treat (ITT) What do you do with the non-compliers, etc.? Intention to Treat analysis (ITT) – “All patients allocated to each arm of treatment regimen are analyzed together “as intended” upon randomization, whether or not they actually received or completed the prescribed regimen. Failure to follow this step defeats the main purpose and advantage of random allocation and can cause serious bias.” –A Dictionary of Epidemiology, 5th Edition Intention to Treat The validity of a randomized controlled trial depends greatly on t