Oversight – Going Mainstream?

In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*. These are commonly known as Suspected Unexpected Serious Adverse Reaction or SUSARs. Timely safety report distribution is important because of its part in improving patient safety but also due to the compelling regulatory obligation to distribute this material promptly.

A Pharmacovigilance Process Summary

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies.

The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical. But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not?

A fortnight ago I found myself in the lovely Italian city of Milan – attending the “Outsourcing in Clinical Trials – Europe” event organised by Arena International

The standout content for me came on the afternoon of Day 1 in a series of quick fire presentations about Oversight Models. As I’m guilty of banging on about oversight for a number of years it was refreshing to listen to a different voice. What struck me in the ideas put forward by Denise Lee, Head of Clinical Operations @ Allergy Therapeutics and Annelies Legters, Senior Director Clinical Operations @ Kiadis Pharma was how ideas about Oversight are now becoming more mainstream. And not a moment too soon.

Let’s recap on the context for Oversight for a moment. Regulators are expecting to see increased evidence of Study Oversight by Sponsors and CROs. The 2018 roll out of ICH E6 R2 has only reinforced the expectation to see Oversight happening on a continuous and contemporaneous basis. But is this actually happening out in the field? How would you answer that question for your current study?

This pattern is further exemplified by the FDA Guidance on risk-based monitoring.

Here at myClin we are seeing a growing number of instances of sponsors hitting regulatory trouble due to lacking Oversight evidence. The cause is often ClinOps processes that typically position Oversight as an extra, parallel process – an additional burden when you’re already “totally maxed out” starting and and executing the study. Inevitably such extra processes can get neglected when time is short and despite best intentions, let’s be honest, we rarely go back and tidy up properly.

The good thing is the Denise and Annelies have useful suggestions to help.

The Allergy Therapeutics approach centres on a Sponsor Oversight Plan with these key features:

  • Oversight is defined in advance
  • Oversight is continuous

Annelies had another useful definition from a colleague:

  • Oversight is proof that you had real-time knowledge of study conduct versus an audit or review after the work is complete.” [Sharon Reinhard, Clinical Compliance Solutions]
  • Part of the Kiadis approach has been to create a new internal Clinical Monitoring Liaison (CML) role – Kiadis staff who are experienced monitors. The Oversight need is satisfied when these CMLs go on co-monitoring visits with the CRO monitors – and of course document their activities promptly. Benefits include maintaining an ongoing relationship with their investigators and site coordinators, in parallel to the CRO and being aware of site issues/concerns.

Much of this chimes with the Oversight practices that myClin recommend to our clients. The myClin Clinical Oversight Platform becomes central to these activities – as the elegant tool that automatically builds your data-driven Oversight evidence pool. myClin is a comprehensive study management tool that brings together:

  • Your Trial Master File (eTMF)
  • and your Investigator Study Files electronically (eISF)
  • your Learning Management (LMS)
  • and Document Management for your hundreds if not thousands of study documents
  • team communication and collaboration.

As well as this platform all myClin clients also get detailed advice as to what Oversight activities to commit to as appropriate to the specific needs of their study(ies). Just as the regulators are expecting.

By Adam Wood, VP, Business Development at myClin

About myClin: Are you really ready for an inspection? Start using the myClin platform to take control of intricate and error-prone study documentation. Keep essential information at your fingertips to stay audit-ready at all times. Get started with more free resources and a demo at myClin.com

About Clinical Works: Are you ready to move faster and smarter with a high impact, curated ClinOps team? We help new bio-pharm ventures and start-ups bridge the gap from investment to clinical development. Find out more at clinical.works

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