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Printable Handouts
Navigable Slide Index
- Introduction
- Structure of session
- Trial design
- The first “trial” - Daniel 1:5-16
- Brief history of landmark clinical trials
- Why (randomized) trials?
- History of ethics in clinical research
- Basic design concepts
- Randomization
- Randomization concepts
- Adaptive randomization strategies
- Clinical equipoise
- Concealment of allocation
- Blinding/masking of “X, Y, Z”
- Other masking considerations
- Sample size considerations
- Types of errors
- Sample size calculation requirements
- Hypothesis frameworks
- Outcome specification
- Choosing an appropriate comparator
- Phases of clinical trials
- Defining a trial’s “purpose”
- PRECIS-2
Topics Covered
- Trial design
- Randomized clinical trials
- Basic trial design concepts
- Concealment of allocation
- Sample size considerations
Talk Citation
Qureshi, R. (2025, March 31). Overview of clinical trials: history and trial elements [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 15, 2025, from https://doi.org/10.69645/IIZG8884.Export Citation (RIS)
Publication History
- Published on March 31, 2025
Financial Disclosures
- Prof. Riaz Qureshi has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Overview of clinical trials: history and trial elements
Published on March 31, 2025
28 min
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello and thank you for your
interest in clinical trials.
My name is Riaz Qureshi and
I'm an assistant professor in
the Department of Ophthalmology
and Epidemiology at
the University of Colorado on
the Anschutz Medical Campus.
I'm an epidemiologist
specializing in methods.
I completed my doctorate at
Johns Hopkins University in
the epidemiology department,
specializing in clinical
trials and evidence synthesis.
Today, I'm going to
give a high-level
overview of clinical trials.
0:28
I've broken this session into
four important sections.
Each of these
sections and indeed
many specific concepts within
the sessions could be covered by
entire lectures and
workshops on their own.
My goal is to provide a
high-level overview of
the distinctions and importance
of trial-related concepts,
designs, and considerations
that you should make if you are
reading a trial publication
or are invited to
work on a trial.
If you want to run a
clinical trial yourself,
I recommend following
this talk with
more detailed courses
and making friends with
your local epidemiologists and
biostatisticians
to help you with
all these considerations
and make the trial the
best that you can to have
the greatest
potential for impact.
This talk will be broken
down into two parts
split after covering
trial design concepts.
1:12
The world of trials is vast and
this talk is going to fly past
as we cover everything from
randomization to
reporting of results.
Even though we will
cover a lot of ground in
the next hour with only a
slide or two per concept,
there will still be
important elements of
running a trial that
I simply can't cover.
For example, considerations of
how to approach recruitment
of participants,
collect data, and
monitor the data
and your trial as
it's happening.
All of these are
also important but
beyond the scope of an
overview of trial designs.
Hopefully, with this
talk, you'll have
enough to get started and a
baseline understanding of
the variation that's
possible when people might
first say have you
considered running a trial?