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A Primer on Safety Signal Interpretation for Clinical Research Careers

If you would like to combine your interest in science and health,then a career in clinical research may be the right choice. When you study clinical research, you have the chance to learn about topics such as pharmacovigilance practices.These generally refer to how pharmaceutical products are developed, tested, and monitored to ensure they are safe and consistent.

One of the key components of pharmacovigilance practices for clinical research,as well as aftermarket surveillance, is safety signal interpretation. Keep reading to learn more about this process and how it factors into clinical research.

What Are Safety Signals?

As you take courses to prepare for CCRP certification, you will begin to understand that the term safety signal refers to information about a pharmaceutical product that establishes a causal link or association between an adverse event or reaction and a drug. The different types of information that are considered to be important in identifying safety signals include:

  • Any reported information on a potential causal relationship between a pharmaceutical product and an adverse event
  • The instance of an aftermarket unlabeled adverse event
  • Observation of new drug-drug or drug- food interactions
  • The identification of a population to be at higher risk than the general population
  • An increase in the frequency or severity of a labelled event

An adverse drug event (ADE), sometimes referred to as an adverse reaction (AR), is defined in Canada as a noxious and unintended response to a drug. If an AR or any of the above occurs, the information must be assessed and evaluated to determine if there is a causal link or association with the drug.Then professionals must determine how the benefit-risk profile of the drug has changed.

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Determination of safety signals is done through analysis of information

How Is Important Information Reported?

Consumers, patients, health professionals, manufacturers, and those with clinical research careers are expected to report any ARs or other safety signal-related information to regulatory organizations. In addition to reports by individuals or through clinical research, AR information is collected through:

  • Post-marketing studies by manufacturers or health care institutions
  • Case reports and surveillance by health care professionals
  • Studies in scientific journals
  • Communication about risk between regulatory agencies around the world
  • Reports in the media

Regulatory bodies, manufacturers, and researchers take this kind of information and use it to strategize further investigation or next steps and to determine risk. Identifying safety signals is crucial to making sure a drug can be safely used, and it must be ongoing throughout a pharmaceutical product’s life cycle.

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Health care professionals and clinical researchers play an important role in drug safety

What Happens After Safety Signals Are Established?

Whenever information about a drug is reported, professionals must assess it to determine whether or not is constitutes a safety signal.If an association between an AR or other event is indeed established one or more of the following measures may be undertaken:

  • (Additional) Post-marketing studies
  • Re-assessment of the risk and benefit profile
  • Product labelling changes
  • Different packaging to clearly identify risks and instructions
  • Dissemination of information
  • Public alerts
  • Additional “warnings” provided with drug information

These types of activities are typically called for by regulatory authorities. The identification of safety signals and subsequent actions ensure that ARs are reduced, especially among high-risk populations. Safety signals also ensure that information about pharmaceutical products and their various benefits and risks are up to date and accessible to the people who need it.

Proper labelling and information is critical for consumers who need pharmaceutical products

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