天津医科大学天津医科大学 Clinical trail. 天津医科大学天津医科大学 1.Historical Background 1537: Treatment of battle wounds: 1741: Treatment of Scurvy 1948:

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天津医科大学天津医科大学 Clinical trail

天津医科大学天津医科大学 1.Historical Background 1537: Treatment of battle wounds: 1741: Treatment of Scurvy 1948: Streptomycin trial 1954: Field Trial of Salk Polio Vaccine comparison between a randomized controlled double-blind clinical trial and a non-randomized open trial

天津医科大学天津医科大学 2.Definition of clinical trail Clinical trail: an experiment study that is designed to compare the therapeutic benefits of two or more treatments. Experimental study: A study in which conditions are under the direct control of the investigator.

天津医科大学天津医科大学

天津医科大学天津医科大学 The purpose of the clinical trail is to provide information that will help in the selection of and use of appropriate,timely, and effective treatments.

天津医科大学天津医科大学 3.Goals of Clinical Trials Treatment Prevention Screening and early detection Diagnostic Prognosis Genetics Quality-of-life / supportive care

天津医科大学天津医科大学 4.Phases of Clinical Trials Phase 1: people What dosage is safe? How should treatment be given? How does treatment affect the body?

天津医科大学天津医科大学 Phase 2: Less than 100 people Does treatment do what it is supposed to? How does treatment affect the body?

天津医科大学天津医科大学 Phase 3: From 100 to thousands of people Compare new treatment with current standard

天津医科大学天津医科大学 Phase 4: From hundreds to thousands of people Usually takes place after drug is approved Used to further evaluate long-term safety and effectiveness of new treatment

天津医科大学天津医科大学 5.Types of clinical trail RCT( randomized controlled trial ) Non-RCT

天津医科大学天津医科大学 RCT

天津医科大学天津医科大学 RCT: Parallel Design Jadad A. Randomized Controlled Trials. BMJ Books; 1998.

天津医科大学天津医科大学 RCT: Crossover Design Treatment Control Outcome Jadad A. Randomized Controlled Trials. BMJ Books; Rand

天津医科大学天津医科大学 RCT: Factorial Design Treatment AControl Treatment B Treatment A and Treatment B Just Treatment A Control Just Treatment B Neither treatment Jadad A. Randomized Controlled Trials. BMJ Books; 1998.

天津医科大学天津医科大学 6.The characteristic of RCT Prospective Intervention Randomization Control Blinding

天津医科大学天津医科大学 7.Process of RCT Draft clinical trial protocol Determine study population Estimate sample size Establish control Randomization Blinding Data analysis

天津医科大学天津医科大学 Process1:Draft clinical trial protocol A written, detailed action plan that: Provides background about the trial Specifies trial objectives Describes trial’s design and organization Ensures that trial procedures are consistently carried out

天津医科大学天津医科大学 Process2:Determine study Population Subset of the general population determined by the eligibility criteria General population Eligibility criteria Study population Enrollment Study sample Observed

天津医科大学天津医科大学 Eligibility Criteria State in advance Consider Potential for effect of intervention Ability to detect that effect Safety Ability for true informed consent

天津医科大学天津医科大学 Process3:Estimate sample size Enumeration data

天津医科大学天津医科大学 Process3:Estimate sample size Quantitative data

天津医科大学天津医科大学 Process4:Establish control Standard control (positive control) Placebo control (negative control) Placebo: an inert medication or procedure Crossover control Mutual control Self control Blank control Historical control

天津医科大学天津医科大学 Process5: Randomization All patients have the same chance of receiving either treatment or control Sequence of allocation to treatment or control must be unpredictable

天津医科大学天津医科大学 Randomization Helps ensure that the treatment and control groups will have similar characteristics both known and unknown factors are equalized Avoids selection bias

天津医科大学天津医科大学 Randomization Simple randomization Block randomization Stratified randomization

天津医科大学天津医科大学 Process6:Blinding A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Goal: to reduce effect of beliefs on symptoms and actions

天津医科大学天津医科大学 Blinding Single blind Unaware: subject Double blind Unaware: subject, observer Triple blind Unaware: subject, observer, data analyser

天津医科大学天津医科大学 Process7:Data analysis Considerations magnitude of the treatment effect precision of the treatment effect statistical significance

天津医科大学天津医科大学 Process7:Data analysis Outcome measure Clarify the endpoint of the trial Both measurements for improvement (desired effect) and possibly side effects

天津医科大学天津医科大学 Process7:Data analysis Index of evaluation Effective rate Cure rate Fatality rate Survival rate Protective rate Index of effectiveness ……

天津医科大学天津医科大学 Bias of RCT Selection bias Measurement bias Placebo effect Loss to follow-up Compliance

天津医科大学天津医科大学 Placebo effect Occurs when persons affected with a specific illness demonstrate clinical improvement when treated with an inert substance.

天津医科大学天津医科大学 Loss to Follow-Up Participants may leave a study for a variety of reasons moving out of town too burdensome to comply with the study protocol experiencing adverse effects from the intervention feeling well or cured by the intervention death How to deal with lost participants find out why the were lost assume the worst, and see how it affects results

天津医科大学天津医科大学 Compliance Adherence to all the requirements of trial- related, physicians, researchers. Drop out (or even drop in) Drug use non-compliance

天津医科大学天津医科大学 Ethical considerations Informed consent: Voluntary consent given by a subject or by a person responsible for a subject (e.g. a parent) for participation in an investigation, immunization program, treatment regimen, etc., after being informed of the purpose, methods, procedures, benefits, and risks. Awareness of risk is necessary for any subject to make an informed choice. Also refers to consent for medical care.

天津医科大学天津医科大学 Ethical considerations Blank control Placebo control Exclusion of women, elderly and others from eligible study subjects

天津医科大学天津医科大学 Non-randomized controlled trial

天津医科大学天津医科大学 Early studies of new and untried therapies Uncontrolled early phase studies where the standard is relatively ineffective Investigations which cannot be done within the current climate of controversy (no “clinical equipoise”)