HSCI 307 Lecture Notes - Lecture 1: Randomized Controlled Trial, Clinical Trial, Cohort Study

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amethystwallaby271

26 Apr 2023

School

Simon Fraser University

Department

Health Sciences

Course

HSCI 307

Professor

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Document Summary

Positivism: valid knowledge and truth is generated through a scientific process based on observation (& measurement) and generalization. Emphasizes rigorous measurement of variables and the analysis of cause-effect relationships. Type of research method: randomized controlled trials (rct). Criticism: focusing too much on the characteristics of the individual (and not enough in their context). A randomized controlled trial (or randomized control trial; rct) is a form of scienti c experiment used to control factors not under direct experimental control. -prospective: participants receive the intervention and then are followed over time. Not blinded (or open): both researchers and participants know. Double-blinding (or masked): : both the treating physicians and the participants are unaware. Triple-blinding: main results are estimated with coded values for treatment- . Purpose is to document the safety of the intervention in humans. Phase 1 studies are usually performed on healthy volunteers. Conducted after the safety of the new intervention has been documented in animal research.

Related Questions

Randomized controlled trials (RCTs) are the strongest research design for establishing cause and effect. Which of the following is the main limitation of RCTs?

a) RCTs may not be ethical for some studies.

b) RCT design cannot control for confounders.

c) Randomized controlled trials may have a disproportionate number of people exposed to the risk factor.

d) Randomized controlled trials are, by their very design, likely to be very biased towards an expected outcome.

universitystudent911

I need to collect information and to write a full description for the following components related to “gelatin-based biomaterial” topic related to Tissue engineering for hearing research: I need the following:

Research Strategy

a. Background with explanations (1 page)

b. Significance with explanations (0.5 page)

c. Innovation with explanations (0.5 page)

d. Approach with explanations (Research Methodology)

i. Rationale (0.5 page)

ii. Experimental for Specific Aims

iii. Potential problems and alternative strategies for each Specific Aim (1 paragraph)

rafi_mokdad

Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power.

Characteristics or indications that subjects must have in order to participate in the clinical trial

DSMB

The probability of detecting a meaningful difference, or effect, if one were to occur

CRO

Prospectively identified and quantifiable parameters that a study is designed to meet

Inclusion criteria

An independent organization that provides management services for clinical trials

CEC

An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study

Endpoints

An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor

Power

An independent body that analyzes data or images from a clinical trial to make specialized quantitative measurements required by the trial protocol

Core laboratory

rafi_mokdad

HSCI 307 Lecture Notes - Lecture 1: Randomized Controlled Trial, Clinical Trial, Cohort Study

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