Why ECGs are Essential to Cardiac Safety in Drug Development

White Paper

Why ECGs are Essential to Cardiac Safety in Drug Development

This white paper explores:

  • Why we collect ECGs during drug development, and the reliability of ECG measurements, interpretations, and evaluations
  • What ECGs reveal in a clinical trial
  • New and modern ECG machines
  • Whether site-collected paper ECGs are equivalent to digitally-collected ECGs
  • The uses of continuous ECG recordings

More about this white paper:

Regulatory authorities have required that cardiac safety data be collected during all clinical phases of the development of a new drug – whether the drug is targeted at a cardiac or non-cardiac indication.  But what exactly does this mean?  Just what sort of data is required?  

The majority of cardiac safety data that is collected during clinical trials is electrocardiographic data. A variety of instruments for collecting ECGs are currently in use, but the best device for use in a clinical trial depends on the mix of sites which will be involved, the specifics of the investigational agent, and the frequency and intensity of ECG collection. Once the ECG is collected, digitally or on paper, it can be read at the site or a by a central core lab.

 The emphasis on capturing ECGs during drug development is simple to understand:

  • ECGs are safe, painless, quick, and inexpensive
  • The devices used to collect 12 lead ECGs are relatively inexpensive, portable, and widely available
  • Paper ECGs printed out by such devices are immediately available for review by the local sites
  • Nearly all physicians have at least some training and familiarity with 12 lead ECGs
  • ECGs are commonly used in clinical practice and therefore familiar to most patients and clinical sites

What you’ll learn:

This paper focuses on the types of cardiac safety data that the FDA and other regulatory authorities typically expect to be collected during drug development, and the various aspects to consider when using ECGs to collect that data.