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European Patients’ Academy on Therapeutic Innovation Clinical Trial Designs
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European Patients’ Academy on Therapeutic Innovation There are several types of trial designs: Non-randomised controlled trial Randomised controlled trial -Parallel group -Cross-over Single or double blind Superiority or non-inferiority trial 2 Trial design types
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European Patients’ Academy on Therapeutic Innovation In a clinical trial design, there are a number of different types of comparisons that can be included: Superiority comparison trials demonstrate that the investigational medicine is better than the control. Equivalence comparison trials demonstrate that the endpoint measure is similar (no worse, no better) to the control. Non-inferiority comparison trials demonstrate that the investigational medicine is not worse than the control. Dose-response relationship trials demonstrate various dose parameters including starting dose and maximum dos. 3 Comparisons
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European Patients’ Academy on Therapeutic Innovation Randomisation is the process of assigning a trial participant randomly (by chance) to treatment or control groups. Different tools are used to randomise (closed envelopes, computer sequences, random numbers). There are two components to randomisation: a)the generation of a random sequence b)Implementation of the random sequence, ideally in a way so that participants are not aware of the sequence. 4 Randomisation in clinical trials
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European Patients’ Academy on Therapeutic Innovation Participants are allocated into treatment and control groups by the investigator. Controls used in non-randomised trials: Concurrent controls: participants matched according to demographics. Historical controls: all participants receive the medicine being studied; the results are either compared to the patient's history (for example a patient living with a chronic illness) or a previous study control group. 5 Non-randomised controlled trials
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European Patients’ Academy on Therapeutic Innovation Participants are randomly allocated between treatment and control groups. Randomisation removes potential for bias. There are different types of randomised trial designs: 1.Factorial design trials 2.Withdrawal trials 3.Parallel group trials 4.Cross-over trials 6 Randomised controlled trials
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European Patients’ Academy on Therapeutic Innovation 7 Parallel groups design
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European Patients’ Academy on Therapeutic Innovation 8 Evaluation of the parallel groups design
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European Patients’ Academy on Therapeutic Innovation 9 Cross-over design (2 x 2)
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European Patients’ Academy on Therapeutic Innovation 10 Evaluation of the cross-over design
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European Patients’ Academy on Therapeutic Innovation 11 Matched-pair design
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European Patients’ Academy on Therapeutic Innovation Stratification ensures balanced allocation within each combination. Studies can be stratified for more than one factor, for example, age and gender. Common stratification factors include by site, age groups, previous exposure, gender, and lifestyle factors. 12 Randomisation using stratification
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European Patients’ Academy on Therapeutic Innovation Find suitable geographical areas (e.g. catchment area, city, country, etc.). Randomly choose a number of these geographical areas For each of these chosen geographical areas, choose a proportional subsample from the members of the study population in that area. Combine these subsamples to get a sample group. 13 Randomisation using cluster sampling
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