Efficacy data vs Safety data

This post is part of 'Domain | General' series

Every clinical trial is conducted to gain some medical knowledge on the (test) drug molecule and assess the Benefit/Risk ratio. 


What is Efficacy (Benefit)?

The ability of a drug or treatment to produce a beneficial result. A drug demonstrates efficacy if it is effective at the dose tested against the illness for which it is prescribed.


  • Lowering the elevated blood pressure
  • Lowering the elevated blood glucose levels
  • Increasing the depleted electrolyte levels

What is Safety (Risk)?

The assessment of any 'undue harm' that might be caused by the drug when used at a dose level to produce an anticipated benefit.

  • Skin rashes caused by a medication as an antibiotic
  • Burning sensation in stomach by a medication which is used for pain relief

What is safety data?

Any data that is collected to evaluate if a drug is causing 'undue harm' is considered as safety data.

Safety of a drug is generally evaluated by examining the below listed examinations.

  • vital signs (blood pressure, saturated oxygen level, pulse rate)
  • laboratory (hematology, chemistry, urinalysis)
  • electrocardiogram
  • adverse events reported (side effects of a drug).

When assessing any safety concerns of a drug in a subject, investigator's may examine the subject demographics, medication history, prior or concomitant medications taken etc. This data is also generally considered as 'safety data' by the 'clinical trial programmers'.


What is efficacy data?

Any data that is collected to evaluate the benefit produced by the drug is called efficacy data.

  • On any regular study, vital signs data may contribute to safety data. However, in a study that is evaluating the ability of a drug to lower blood pressure, vital signs data will be called efficacy data.
  • On any regular study, hemoglobin (laboratory parameter) may contribute to safety data. However, in a study that is evaluating the ability of drug to increase hemoglobin level, hemoglobin (lab data) will be called efficacy data.

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The Drug development process
Overview of clinical trial process
What is a clinical trial?
Who conducts clinical trials?
Why are clinical trials conducted?
What are the phases of clinical trials?
What is a clinical trial protocol?
Case Report Form (CRF)
What is a clinical trial registry?
Factors affecting drug metabolism and activity
Prior and Concomitant medications
Inclusion/Exclusion Criteria in a clinical trial
What happens after a clinical trial is completed?
The Investigational New Drug Process
Preclinical Research
Drug discovery
FDA Drug Review
What is the importance of baseline characteristics in a clinical trial?
Why do we need CDISC standards?
What is a clinical development plan?
What is a clinical study report?
"Exploratory study" vs "Confirmatory study"
What is ICH?
Clinical trial registries
Efficacy data vs Safety data
What is clinical data management?

Trial design aspects
What is a crossover clinical trial?
What is blinding in clinical trials?
What is an open-label clinical trial?
What is randomization in clinical trials?

What is a cohort?


What is a computer?
What happens when we execute a SAS program?
What is software?
What is SAS?
What is data?
What is data entry?
What is data retrieval?
What is data management?
What is "Report"?
What is statistics?
What is Statistical Analysis?
How do we use SAS?
What kind of questions can SAS help us answer?
How do we provide instructions to SAS?
What is a SAS program?
What does a SAS program contain?

Attributes of a SAS dataset
Rules for SAS dataset names
Rules for SAS variable names
Rules for SAS library names
Rules for character SAS format names
Reserved SAS dataset names
Rules for numeric SAS format names
What can SAS dataset options do?
Attributes of a SAS variable
Automatic conversion of data types in SAS
How does SAS expect our data to be organized?
Introduction to SAS interface
By groups in SAS

Rules for character SAS informat names

Proc freq
Count the number of times a particular value occurred in a variable of a dataset

Proc contents
Check the list of variables in a SAS dataset

Proc datasets
Delete all sas datasets from a library
Delete specific sas datasets from a library
Save specific sas datasets (and delete others) of a library
Rename SAS datasets using proc datasets change statement

Log issues
WARNING: No matching members in directory.

One-line definitions
What is a SAS library?
What is a libref?
What is an input statement?
What is infile statement?
What is set statement?
What is length statement?


How to derive baseline flag in SDTM
How to create SEQ variable in SDTM
New domains in SDTM IG 3.3
What is a codelist?
How to derive study day variable in SDTM
What is SDTM?
Why do we need SDTM?
How to convert original results to standard results using conversion factors

What information does SDTM.DM (Demographics) contain?

Adverse Events
What is causality assessment?
What information does SDTM.AE (Adverse Events) contain?

What information does SDTM.DS (Disposition) contain?

Concomitant Medications
What information does SDTM.CM (Concomitant/Prior Medications) contain?

What information does SDTM.PR (Procedures) contain?


What is ADaM?

What is ADSL as per ADaM standard?

What is BDS as per ADaM standard?


What is correlation?
Descriptive statistics
Inferential statistics
ANCOVA - Basic example
ANOVA - Basic example
Alpha (Type I) error
Beta (Type II) error


What is R?
What is an R package?
What is tidyverse?
What are the core packages of tidyverse?
What is haven package of tidyverse?
How to install tidyverse?
How to load core tidyverse packages into the R session?

Reading data
Import/Read SAS dataset into R

Creating sample data
How to create some sample data in SAS and R tidyverse

Subset variables (columns)
How to select only required variables/columns in SAS and R tidyverse?
How to drop unwanted variables/columns in SAS and R tidyverse?

Subset observations (rows)
How to select/subset required rows in SAS and R tidyverse

Appending data
Append two datasets in SAS and R tidyverse

Merging/joining data
Merge/full join two datasets in SAS and R tidyverse
Merge/inner join two datasets in SAS and R tidyverse
Merge/left join two datasets in SAS and R tidyverse

Sort (order) observations
Sort/order observations based on the values in a single variable in SAS and R tidyverse

Transpose/Restructure data
Restructure/transpose long data to wide data
Restructure/transpose wide data to long data

Obtain frequencies
Obtain frequencies/counts based on one variable - one-way frequencies in SAS and R tidyverse
Obtain frequencies/counts based on two variables - two-way frequencies in SAS and R tidyverse

Descriptive statistics
Descriptive statistics for a numeric variable using SAS and R tidyverse