Good Clinical Practice in the Era of COVID-19

Posted by Heather Pitt on Jun 8, 2020 11:19:32 AM

The significance of Good Clinical Practice (GCP) is starkly highlighted now, as pharma companies and countries globally race to find COVID-19 treatments. We all know the huge and tireless efforts that are ongoing and the palpable desire for rapid results.  

It’s widely recognized that there are opportunities to accelerate clinical trials and many of us devote our working lives to this goal. There is always scope for improved processes, smarter tools, and elimination of waste. However, in this pressure cauldron moment, we need to remember that GCP is not a bureaucratic millstone to be circumvented.

GCP may hail from the last century, but its tenets remain critical during this rush to find effective treatments for COVID-19. In this challenging global situation, GCP ensures that our research remains ethical, rigorous, and successful.

The international quality standard of GCP originated in the Nuremberg Trials, when the horrific Nazi experimental practices were prosecuted and the defense hinged on the lack of ethical guidelines for research on people. From that came the Nuremberg Code in 1947, the first international document advocating voluntary participation and informed consent.

In the 1960s, public awareness of the dangers of medicines grew after the sedative Thalidomide caused fetal deformities in Europe. In 1964, the Nuremberg Code was codified into the Declaration of Helsinki, declaring that the safety of the patient is the primary consideration in clinical studies. Culminating in the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, GCP is the cornerstone of all clinical research.

The core principles remain as follows:

  • Safety and well-being of trial patients
  • Trials are conducted with rigor and integrity
  • Resulting data is reliable and usable by investigators across the globe

GCP must be woven into the design, execution, oversight and management of any clinical trial. This includes ensuring that sites have up-to-date training and certification so the trial itself won't be jeopardized by a GCP lapse.

Developing an effective COVID-19 vaccine is of paramount importance. However, imagine the repercussions if billions of people globally were to receive a COVID-19 vaccine that later turned out to have safety issues?

Staying up-to-date on current practices assumes greater importance in this rapidly shifting landscape. Below please find links to guidance from regulators issued in response to the COVID-19 pandemic. These cover clinical trial management and GCP considerations. Please check these regularly for updates.

Topics: Clinical Research Conduct, ICH GCP, Informed Consent, Clinical Trials, COVID-19

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