Clinical SAS terms

Clinical Study
A clinical study involves research
using human volunteers (also called
participants) that is intended to add
to medical knowledge. There are two
main types of clinical studies: clinical
trials and observational studies.
Clinical Trials includes both
interventional and observational
studies.

Drug trials report

They arefundamental to the development
of innovative medicines, vaccines and
devicesthat treat and prevent illness.
Medicines, vaccines and devices tested but
not yet been approved by health
authorities.
Currently available for sale, and being
tested toIMPROVEexisting formulations or
evaluate their potential in other diseases.

Drug development
Drug discovery and development process efforts
begin and end with the patient. R&D efforts are
guided by two principles:
Do we understand the underlying mechanism or
cause of the disease?
Does this disease represent a significant unmet
medical need in patients?
If the answer to both questions is "yes," then
develop a research program aimed at better
understanding the disease and finding an
effective chemical or biologic based medicine.

Drug approval process

The first is the preclinical phase, which usually
takes 3 to 4 years to complete. If successful, this
phase is followed by an application to the FDA as
an investigational new drug (IND).
After an IND is approved, the next steps are clinical
phases 1, 2, and 3, which require approximately 1,
2, and 3 years, respectively, for completion
( Table ).
Importantly, throughout this process the FDA and
investigators leading the trials communicate with
each other so that such issues as safety are
monitored.

Continue
The manufacturer then files a new drug
application (NDA) with the FDA for approval.
This application can either be approved or
rejected, or the FDA might request further
study before making a decision.
Following acceptance, the FDA can also
request that the manufacturer conduct
additional post marketing studies. Overall,
this entire process, on average, takes
between 8 to 12 years.

FDA
Guidance documents included under the umbrella title
of FDA Information Sheets represent the agency's
current thinking on protection of human subjects in
research.The date following the title of each document
represents the most recent update for that subject.
Many documents were last updated prior to the
enactment of good guidance practice requirements.
As further updates become necessary, reformatting of
some documents may therefore be necessary.
While most will still be included under the umbrella of
Information Sheets, some may be accessible separately
after update.

Clinical trials phase 1

Phase I trials are the first stage of
testing in human subjects.
Testing of drug on healthy volunteers
for dose-ranging.

Phase 2 and 3
However there are many phases
such as preclinical, phase
0,1,2,3,4,and 5.
Phase 2- Testing of drug on patients
to assess efficacy and safety.
Phase 3- Testing of drug on patients
to assess efficacy and safety.

Phase 4 and 5
Phase 4 Postmarketing surveillance
watching drug use in public.
Phase 5- For translational research.

Skewness
Skewness: indicator used in distribution ANALYSIS as a
sign of asymmetry and deviation from a normal
distribution.
Interpretation:
Skewness > 0 - Right skewed distribution - most values
are concentrated on left of the mean, with extreme values
to the right.
Skewness < 0 - Left skewed distribution - most values are
concentrated on the right of the mean, with extreme
values to the left.
Skewness = 0 - mean = median, the distribution is
symmetrical around the mean.

Kurtosis
Kurtosis - indicator used in distribution ANALYSIS as a sign of
flattening or "peakedness" of a distribution.
Interpretation:
Kurtosis > 3 - Leptokurtic distribution, sharper than a normal
distribution, with values concentrated around the mean and
thicker tails. This means high probability for extreme values.
Kurtosis < 3 - Platykurtic distribution, flatter than a normal
distribution with a wider peak. The probability for extreme
values is less than for a normal distribution, and the values
are wider spread around the mean.
Kurtosis = 3 - Mesokurtic distribution - normal distribution for
example.