Nonrandomised controlled trial Randomised controlled trial Parallel group Crossover Single or double blind Superiority or noninferiority trial 2 Trial design types In a clinical trial design there are a number of different types of comparisons that can be included ID: 1009934
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1. Clinical Trial Designs
2. There are several types of trial designs:Non-randomised controlled trialRandomised controlled trial Parallel groupCross-overSingle or double blindSuperiority or non-inferiority trial2Trial design types
3. 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.3Comparisons
4. 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: the generation of a random sequenceImplementation of the random sequence, ideally in a way so that participants are not aware of the sequence.4Randomisation in clinical trials
5. 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.5Non-randomised controlled trials
6. Participants are randomly allocated between treatment and control groups.Randomisation removes potential for bias.There are different types of randomised trial designs:Factorial design trialsWithdrawal trials Parallel group trialsCross-over trials6Randomised controlled trials
7. 7Parallel groups design
8. AdvantagesChallengesCan be applied to almost any diseaseHomogenisation of the groups (Especially where different geographical locations are used)Any number of groups can be run simultaneouslyGroups can be in separate locations8Evaluation of the parallel groups design
9. 9Cross-over design (2 x 2)
10. AdvantagesChallengesLow variance due to treatment and control being the sameCan only be applied to chronic illnesses as treatments are applied one after the other oneCan include a number of treatments10Evaluation of the cross-over design
11. 11Matched-pair design
12. SmokersNon-smokersParticipant NoRandom arm/groupParticipant NoRandom arm/group001A003B002B005A004B006BStratification 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. 12Randomisation using stratification
13. Find suitable geographical areas (e.g. catchment area, city, country, etc.).Randomly choose a number of these geographical areasFor 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.13Randomisation using cluster sampling