Randomized controlled trials: Triple Blind

It is a presentation assignment in my academic.

1. Assignment on M.sc in Biostatistics and Demography Presenting by Under the guidance of Akash Patel Dr. Sarang Pedgaonkar International Institute for Population Sciences, Deonar, Mumbai-400088. [IIPS/MBD(2021-2023)/50] Randomized controlled trial: Triple Blind

2. Outline Randomized controlled trial(RCT) : Introduction Key Features of RCT Why RCT? Types of RCT Blinding of The Trial Why Do We Blind? Triple Blind

3. Randomized controlled trial is a form of scientific experiment used to control factors not under direct experimental control. An RCT in clinical research typically compares a proposed new treatment against an existing standard of care; these are then termed the 'experimental' and 'control' treatments, respectively. When no such generally accepted treatment is available, a placebo may be used in the control group so that participants are blinded to their treatment allocations. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences. Randomized controlled trial : Introduction

4. Key Features of RCT Randomization : To make study groups comparable on all factors except for Exposure Status. Blinding : Patient and /or investigator should be unaware of the Treatment assigned (single, double, triple). Ethical Concerns : “first, do no harm, ” stopping rules. Intention to Treat Analysis : “analyze what you randomize. ”

5. Why RCT? A well-blinded RCT is considered the gold standard for clinical trials. RCT are prospective longitudinal studies Allowing causal association between intervention and outcomes. Makes groups comparable. Controls and confounding (known and unknown). Prevents selection bias. The random selection of participants into each arm and the controlled way in which trial is carried out mean that all factors are considered equal. Other study design cannot infer causality.

6. Types of RCT

7. Blinding of The Trial Blinding is a procedure in which one or more parties in a trial are kept unaware of which treatment arms participants have been assigned to, i.e. which treatment was received. Blinding is an important aspect of any trial. How a trial was blinded should be accurately recorded in order to allow readers to interpret the results of a study. If blinding is ever broken during a trial on individual participants, it needs to be justified and explained.

8. Why Do We Blind? Blinding is used to prevent conscious or unconscious bias in the design of a clinical trial and how it is carried out. This is important because bias can affect recruitment and allocation, care, attitudes, assessments, etc. It is used to ensure the objectivity of participants, study staff, clinicians, data collectors, outcome adjudicators and data analysts.

9. Triple-blind studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual who administer the treatment or intervention, and (c) the individual who assess the outcomes. This ensures that bias for or against the tested treatment is very unlikely to occur. Medicine may still be labelled as A or B during analysis. Analyst is blinded to which treatment is which. Helps to avoid bias in the analysed results. Triple blind usually means a double-blind trial that also maintains a blind data analysis. The purpose of triple-blinding procedures is to reduce assessment bias and to increase the accuracy and objectivity of clinical outcomes. Triple Blind

10. Thank you