Clinical Trials PDF

-Types of interventional studies - Definition, phases and problems associated with clinical trials -Different types of research blinding Interventional studies Clinical trials Quasi experiment Quasi experiments  Clinical trials Definition: I...

-Types of interventional studies - Definition, phases and problems associated with clinical trials -Different types of research blinding Interventional studies Clinical trials Quasi experiment Quasi experiments  Clinical trials Definition: It is an experimental study that is designed to compare the therapeutic benefit of two or more treatments. Aim: To compare a new drug or vaccine with a traditional one according to its:- 1. Cost-effectiveness 2. Effectiveness. 3. Safety (toxicity and side effects).  Clinical trials Definition: It is an experimental study that is designed to compare the therapeutic benefit of two or more treatments. Aim: To compare a new drug or vaccine with a traditional one according to its:- 1. Cost-effectiveness 2. Effectiveness. 3. Safety (toxicity and side effects).  Clinical trials The clinical trial is a prospective study with two differences:- Prospective study Clinical trial 1. Subjects select themselves for 1. Randomization:- The investigator exposure or non-exposure to randomly determines who will be the factor exposed (treated) or not 2. No blinding is applied 2. Blinding is applied  Clinical trials Blinding definition: keeping people unaware of treatment group - It should be applied whenever possible If blinding is absent Affect the perception of outcome Reduce confidence in the study result.  Clinical trials Blinding may be: 1. Subject under investigation............................ single blind 2. Subject and data collector (researcher)...............................double blind 3. Subject + investigator+ data analysts...............triple blind Blindness can be achieved by using a similar shape or color and taste…or using placebo.  Clinical trials Phases of clinical trials Phase 1 Phase 2 Phase 3 Phase 4 Number of 15-30 Less than 100 From 100 to Several participants thousands hundreds or thousands Purpose - To find safe - To determine - To compare - To further dosage if the agent has the new agent evaluate the - To decide how an effect on with the long-term the agent particular current safety and should be given disease standard effectiveness of - To observe - To see how a new how the agent the agent treatment affects the affects the human body human body Clinical trials compare the new agent with the current standard Clinical trials  Clinical trials Correctly defining inclusion and exclusion Sample size. criteria. Non participation, non-compliance, Expenses attrition Problems Ethical issues encountered Long period in clinical of follow up trials  Prospective study Clinical trial Clinical trialsCorrectly defining 1. Subjects select themselves for 1. Randomization:- inclusion and The Sample investigator size. exclusion criteria. exposure or non-exposure to randomly determines who will be the factor exposed (treated) or not Quasi Non participation, non-compliance, Expenses experiment 2. No blinding is applied attrition 2. Blinding is applied Problems Ethical encountered Long period issues in clinical of follow up trials 1. Enumerate the two types of interventional studies? 2- List the problems encountered in clinical trials?