Quick Notes: Randomized Controlled Trials (RCTs)- By Vaishnav Nair

● Prospective study - cohort is tracked over time and data is collected
● Measures effectiveness of new interventions/treatments
● Randomization - assigning participants to treatment or control groups based on chance
    ○ Observed and unobserved characteristics are balanced among both groups
    ○ Reduces bias
    ○ Helps better determine causality because any differences in outcome are more likely to be attributed to the intervention
● Steps to design:
    ○ 1. Population, interventions, and outcomes of interest are determined
    ○ 2. Power calculation - number of participants needed to reliably determine if a relationship exists between    the intervention and outcome of interest
    ○ 3. Participants are recruited and randomly assigned to either the comparison or treatment group.     
             ■ Concealment - the participant in unaware of which group they will be a part of
             ■ A computer will often determine the groups to minimize bias; doctors and nurses are often unaware of which participants are in which group
● Subtypes:
    ○ Intention-to-treat analysis (ITT): subjects analyzed in the groups they were placed into; often regarded as least biased
    ○ Per-protocol: one those who completed the treatment are analyzed and based on what treatment they received
     ○ Others exist but are less common
● Drawbacks:
    ○ High costs (both in time and money due to nature of tracking over time)
    ○ Participants may not be generalized as a representation of the population being studied
    ○ Lack of follow up