Clinical Research: Part 3 RCTs

Overview How does an RCT differ from an experiment? What are the key considerations in the design and evaluation of RCTs? What are the key considerations in the choice of comparators?

Randomized Controlled Trial Simply an experiment designed to influence a clinical outcome Experiment = random assignment across two or more conditions Clinical outcome = physical or mental health outcome (notably somewhat ambiguous)

Key Considerations (APRICOT) Aims or goals of the research Participants (eligibility, sample size, and accrual) Randomization procedures Intervention(s) Control/Comparator condition(s) Outcome measures Timeline of intervention, assessment, follow-up You could take multiple courses based on the details of this slide alone, but consider PSYC 6100

Ethical issues? Scientific issues? Comparators Placebo Substance lacking active treatment ingredient Any observed effect (placebo effect) is due to a self-fulfilling prophecy Inert vs. active placebo Waitlist Treatment as Usual (or Usual Care, or Enhanced Usual Care) Alternative Intervention Ethical issues? Scientific issues?

Ethical issues? Scientific issues? Comparators Placebo Substance lacking active treatment ingredient Any observed effect (placebo effect) is due to a self-fulfilling prophecy Inert vs. active placebo Waitlist Treatment as Usual (or Usual Care, or Enhanced Usual Care) Alternative Intervention Ethical issues? Scientific issues? Many treatments are harmful if not toxic in the short-run, have unknown long-term side effects, are ineffective, and/or expensive

Ethical issues? Scientific issues? Comparators Placebo Substance lacking active treatment ingredient Any observed effect (placebo effect) is due to a self-fulfilling prophecy Inert vs. active placebo Waitlist Treatment as Usual (or Usual Care, or Enhanced Usual Care) Alternative Intervention Ethical issues? Scientific issues? Many have no/few resources

Types of Studies Efficacy Study: Compares a new intervention to a control condition under highly controlled or ideal circumstances (narrow eligibility, no concurrent interventions, expert interventionists, plentiful resources, mechanisms assessed) Effectiveness Study: Compares a new intervention to a control condition under real-world circumstances (broad eligibility, fewer resources, lower expertise, flexible) Comparative Effectiveness Study: Compares two or more interventions that are empirically supported and/or commonly used