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.

Examples:

  • 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.