ICH E14 and S7B: A Note From the SPS President

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Dear Members of SPS,

Since the link between serious ventricular arrhythmias among patients taking e.g. terfenadine was discovered in the early 1990s, drug developers and regulators worldwide have searched for an optimal and efficient risk assessment of drug-induced QTc interval prolongation and torsades de pointes arrhythmia leading to release of the ICH S7B and ICH E14 in 2005; a topic that has been key to the Safety Pharmacology Society (SPS) since its inauguration in 2000.  As we all acknowledge, these guidelines have been very successful but despite the concurrent release of the guidelines the recommended nonclinical evaluations of risk for QT prolongation unfortunately have minimal impact on the ICH E14-based recommendation for assessing clinical QTc prolongation.

Therefore, there is no doubt in my mind that the updated Q&A to the ICH E14 and ICH S7B as well as the effort in linking these guidelines together is a very important piece of work. On behalf of SPS, I wish to recognize and thank the many people in the ICH E14/S7B Implementation Working Group (IWG)  who have worked diligently on getting the Q&As to the current stage; Step 2b and release for public consultation. As Past Presidents and Members of SPS, we wish to specifically recognize and thank Hugo Vargas, Jean-Pierre Valentin, Derek Leishman and Eric Rossman (In Vivo Project Manager) who have been at the front of this important work.  They are also responsible for the very successful session on this topic at the SPS Virtual Annual Meeting on September 16, 2020 and we will continue to liaison with them to provide you with future updates and information.

We also thought it important to share the survey data from that session collected from the attendees who participated. To quote the survey data, ”A majority of respondents (53%) believed that the Q&As will improve QTc/ proarrhythmia assessment” but the data also highlights some important concerns: “A majority of respondents (50%) do foresee issues with implementing the nonclinical strategy”.

I am pleased to see how these Q&As are re-enforcing the value of the nonclinical data generated to assess the overall risk for QTc-prolongation and torsades de pointes arrhythmia. As stated in the recently published paper by the IWG (Vargas HM et al, 2020) “The time has come to meaningfully merge nonclinical and clinical data to enable a more comprehensive, but flexible, clinical risk assessment strategy for QTc monitoring”.

To keep you informed on this important issue, we plan to host a series of webinars in 2021 for SPS Members. Members will receive updates on the Q&As and will have opportunities to provide input on the implementation process and finalization of the Q&A guideline updates.

Please watch for more information in the coming months through all SPS news outlets (website, newsletters, blogs and social media).

On behalf of SPS

Tomas Mow, DVM, PhD, DSP

2020 President, Safety Pharmacology Society

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