Risks in clinical trials…Share your opinions on this topic to stay better informed

Posted in Regulatory, Risk Mitigation

In today’s clinical trial landscape, “risk” is an omnipresent word.  Every aspect of conducting a clinical trial has some inherent level of risk and decision makers continue to grapple with finding the best ways to identify risk, understand impact and proactively mitigate it.  Recent regulatory changes like the implementation of ICH E6 R2 mandate companies to formalize risk-based approaches to quality oversight and the desire to learn how others are combating similar challenges has increased.

At the Avoca Quality Consortium (AQC), this topic has been top of mind for several years.  In 2013, we surveyed 70 Sponsors and nearly the same number of CROs/clinical service provider organizations to learn about the methods used to assess and manage risk in outsourced clinical trials.  The research had a focus on risk-based approaches to oversight and quality management.  We explored risk sharing models and their success, the use of systematic risk assessments, and the utility of risk-based management approaches including risk-based monitoring.  The summary of key learnings can be picked up here.

Flash forward to late 2016, and our 65+ AQC Member companies overwhelmingly voted this as the single most important topic that that they need more data and help on.  And we’re on it.  Avoca just launched our 2017 survey that is open to the entire industry.  We want to collaborate with you on achieving a better state of understanding of the evolving landscape of risk and risk-based approaches to managing quality in clinical research.

To enable longitudinal comparison, we’ve included many of the topics covered in 2013, and have expanded the scope to include:

  • risk-based approaches to CRO and clinical service provider oversight and inspection readiness
  • aligning risk assessment and risk management to ICH E6 R2
  • alignment of inspections to risk based approaches outlined in regulatory guidance
  • technology enablement for risk assessment and
  • areas of greatest impact and challenge

We invite you to take part in this important research effort.  As a participant, you will get the data you need to be better informed and equipped to mitigate risks effectively in outsourced clinical trials.