SAS Clinical Trail programming exam
What is Randomized Clinical Trial(RCT)?
What are 4 Clinical Trial Phases?
Foreword: A testicular cancer patient asks his urologist whether the orchiectomy will be painful.
The doctor replies "only when you get my bill".
• SAS Clinical Trail programming exam Overview
Recently SAS launched this new Clinical Trail programming exam, this credential validates a candidates' ability to apply SAS programming skills to clinical trials data.
A candidate for this exam should have experience in
clinical trials process
accessing, managing, and transforming clinical trials data
statistical procedures and macro programming
reporting clinical trials results
validating clinical trial data reporting.
• What is Randomized Clinical/Control Trial?
A study in which people are allocated at random
(by chance alone) to receive one of several clinical interventions or placebo, it is to prevent biases.
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: The subjects involved in study do not know which treatment they receive.
If the study is double-blind, the researchers also do not know which treatment is being given to any given subject.
This 'blinding' is to prevent biases, since if a physician knew which patient was getting the study treatment and which patient was getting the placebo,
he/she might be tempted to give the (presumably helpful) study drug to a patient who could more easily benefit from it. Click the previous link on the adds to download the following slides.
In addition, a physician might give extra care to only the patients who receive the placebos to compensate for their ineffectiveness.
A form of double-blind study called a "double-dummy" design allows additional insurance against bias or placebo effect.
In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study.
• What are 4 Clinical Trial phases?
Phase I: determine the safety
of a new treatment to health volunteers.
Phase II: determine whether a certain disease responds to a new treatment
Phase III: study whether a new treatment is better than standard treatment
Phase IV: find more information about a new treatment that has been already approved for use in patients.
: Normally, a small (20-100) group of healthy volunteers will be selected.
This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics
of a drug.
They look at how the drug is handled in the human body, particularly with respect to the immediate short-term safety to higher doses.
: performed on larger groups (100-300), examine dose-response curves in patients and what benefits might be seen in a small group of patients with a particular disease.
: studies are randomized controlled multicenter trials on large patient groups (300–3,000) and are aimed at being the definitive assessment of how effective the drug is,
in comparison with current 'gold standard' treatment.
Because of their size and comparatively long duration, Phase III trials are the most expensive,
time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.
A positive study in Phave III is often knows as a landmark study for a drug, through which it might gain a licence to be prescribed for a specific disease.
: also known as Post-Marketing Surveillance Trial
. It involves the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.
This study are critical for gathering additional safety information from a larger group of patients in order to understand the long-term safefy of the drug.
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