Date: Sun, 9 Feb 2003 14:28:36 -0500
Reply-To: "John J Genzano, III" <jgenzano@GENZANO.COM>
Sender: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From: "John J Genzano, III" <jgenzano@GENZANO.COM>
Subject: Re: Clinical Trial Phases
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If I remember correctly, for non-cancer drugs:
Phase I - first human trials; small population to test safety on humans,
i.e., make sure it don't kill 'em.
Phase II - dosage trials; small populations of sick humans to test
different dosages to determine which dosage regiment is best.
Phase III - efficacy trials; larger populations are tested against
existing drugs (if available) or placebo to determine if the efficacy of
the test drug is at least as good if not better than the other
treatment. There will normally be a fair number of trials at this phase,
especially if there are multiple existing drugs for the indication.
Phase IV - ongoing safety and/or additional indications; normally after
the drug is approved, drug safety is continually tracked and new
indications are tested.
John J Genzano, III
Genzano Software Consulting
SAS Certified Professional, V6
"Even when the experts all agree, they may well be mistaken." - Bertrand
Earning $100,000 a year is just as easy as earning $15,000 when you know
From: SAS(r) Discussion [mailto:SAS-L@LISTSERV.UGA.EDU] On Behalf Of
Sent: Sunday, February 09, 2003 1:49 PM
Subject: Re: Clinical Trial Phases
What are the different stages of clinical trials?
Developmental cancer treatments progress through four phases:
Phase I: Phase I trials are the first trials conducted on humans for a
new drug or treatment. It may not always be a new drug, but can be new
combinations of already approved drugs or a new drug together with
approved treatments. The goal of a phase I study is to define the dose
of the drug that should be given in future studies and the potential
side effects of the medication. Sometimes the efficacy of a drug is
reported on, but evaluating cancer responses is not the objective of a
phase I study.
Phase II: Phase II trials are designed to evaluate how well a drug works
against a particular cancer. They require more patients than phase I
studies. A side effect may occur that was not seen in the phase I study
because there are more patients. The safety of the treatment continues
to be evaluated in phase II studies as well as the efficacy.
Phase III: Phase III trials take a treatment that looks to be successful
after phase II studies and directly compares it to a standard treatment
for a certain cancer to see if the new treatment is better for patients.
Patients are randomly assigned different groups and these groups receive
different treatments. The groups are then compared to see if one of the
treatments worked better against the cancer and the side effects are
Phase IV: Phase IV trials are typically done after a drug has finished
development and is approved by the FDA and on the market. The purpose is
to continue studying the effects of a treatment on different populations
and to look for any toxicity that may occur with long-term use.
SAS in CT:
1. Database, data management:
+ which datasets are likely to be used in CT and what purpose
+ can you code general range of values checks against the data
+ use of common statistics to verify outliers (extreme values)
+ defining baseline requirements, such as expectation of text
descriptions and/or formats
+ process EXCEL data, flat files, longitudinal data
+ direct access to a Clintrial database, via ACCESS or SQL
2. Information delivery: reporting and analysis
+ processing lab data
+ working on adverse events reporting
+ transcribing the CRF values/range-of-values into reporting
+ creating acceptable graphs
+ documentation for indexing purposes
+ portability of code to different environments
+ use of other software for output delivery--PDF, Word
Joe Ricker <dandr@WORLDNET.ATT.NET> wrote:
I am totally illiterate when it comes to Clinical Trials.
Can someone please explain the different Phases of clinical trials, and
they relate to SAS.
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