Phase 2 clinical trial.pptx

Phase 2 of clinical trial is presented here.

1. Presentation On Phase-II Clinical Trial

2. Group members Mahamuda Jahan Shelly ( ID:11715004) Tanvirul Islam ( ID: 11715010) Samiha Rahman ( ID: 11715041) Md Saiful Islam (ID:11715042) 2

3. Mahamuda Jahan Shelly ID:11715004 Department of Pharmacy Comilla University

4. Introduction Clinical trials are studies performed with human subject to test new drugs or combinations of drug , new approaches to surgery or rediotherapy or procedures to improve the diagnosis of disease the quality of life of the patient. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. Clinical trial is the mainstay for bringing out new drugs to the market. 4

5. Phases of Clinical Trial 5

6. Phase-II Clinical Trial It is also known as therapeutic exploration and dose ranging. Conducted by physician , trained as clinical investigators. Based on a specific inclusion and exclusion criteria about 100 to 400 patients are selected. The main aim is establishment of therapeutic efficacy doses range and ceiling effect in a controlled setting. Tolerability and pharmacokinetics are studied. Phase can be blinded or open labelled. Carried out at 2-4 centre. 6

7. Phase II studies: Pre-requisites Review of Phase I data . Innovator / Experts . IRB . DCGI Prior approval by IRB and DCGI is mandatory For new actions of marketed drug , start with phase II ( Phase I exemption obtained ) 7

8. Objectives of Phase-II Efficacy in patients (primary objective) Safety issues ( secondary objective) Optimum dose finding . Dose efficacy relationship . Therapeutic dose regiment . Duration of therapy . Frequency of administration . Therapeutic window 8

9. Tanvirul Islam ID: 11715010 Departmment of Pharmacy Comilla University

10. TYPES OF PHASE-II CLINICAL TRIALS 10

11. Stages of Phase-II 11

12. T ypes based on process design 12

13. 13

14. Randomized design Randomize patient to different drugs or dose levels of the same drug Can estimate difference between treatments Can pick the treatment of best response Randomization produces balanced groups 14

15. Platform trials Multiple treatments evaluated simultaneously More efficient than traditional RCT designs 15

16. Cross-over design In a crossover study design,  two or more treatments (e.g., drugs, procedures) are provided to subjects at different time periods, and the sequence of treatments is randomized for each subject . 16

17. Samiha rahman ID: 11715041 Department of Pharmacy Comilla University

18. Phase II(a) vs Phase II(b) Phase II (a) Phase II (b) EARLY PHASE LATE PHASE Pilot clinical trials Pivotal clinical trials 20-200 Patients 50-300 Patients Not multicentric Multicentric Single Blind comparison with a standard drug Double Blind comparison with a placebo or standard drug 18

19. How do doctors put volunteers into groups in phase-II trial: Use computer program Put volunteers into different groups Each volunteer has an equal chance of going in any of the groups This process is known as Randomization Research staff checks the benefit of the treatment If the staff change the volunteer into new treatment groups, the trial result will be changed But randomization helps to avoid this 19

20. Population of Phase-II Trial Consists of multiple subgroups Specify the response rate and prevalence of each subgroup Calculate the response rate for whole population Choose standard phase 2 design to test on the response rate Observed prevalence among the accrued patients to the study may be quite different More high risk patients are rejected 20-300 Subjects Individual with target disease 20

21. Sample Size Determination Having the right sample size can ensure that if a statistically significant difference exists, it will be uncovered. Effect size is small a larger sample size is required Effect size is large a smaller sample size is required Correct sample size assure Correct participants Having a sufficient sample size can help save money and make sure the efficient use of resources 2 groups People receive the usual treatment People receive the usual + new treatment 21

22. About 70% of potential new drugs will progress to phase 2 Measuring safety and evaluating side effects Most research projects fail in phase 2 due to less effectiveness of product Several months to 2 years or <1-2 years Duration of Phase-II Trial 22

23. MD Saiful Islam ID:11715042 Departnent of Pharmacy Comilla University

24. Goals of phase- ll trial Primary goals To evaluate the efficacy in the patient with particular disease To evaluate the safety occasionally Finding the best dose Secondary goals To investigate pharmacokinetics of drugs To investigate pharmacodynamics of drug To evaluate immunogenicity 24

25. Dose determination Also known as dose finding phase Maximum tolerable dose is determined in phase-l Dose is determined by dose ranging study Different doses of an agent are tested to establish the best dose Trial starts with minimum dose but not exceed maximum tolerable dose A dose ranging study includes a placebo group and a few groups receiving different dose of the drug 25

26. Eligibility of the subject Patients with particular disease that the drug being studied is trying to cure Patients will have short medical history Patients with multiple diseases should be avoided Patients should be able and willing to comply with the requirement of the trial Patients should voluntarily agreed for trial Pregnant and breastfeeding female should be excluded Patient allergic to the drug should be excluded 26

27. THANK YOU 27