Making Sense of ICH E6 (R2): Preparation and Implementation Best Practices

In our 2016 CRO Oversight Benchmark Survey, more than 100 clinical operations leaders from life sciences organizations claimed that CRO oversight is seen as a top priority, but yet are not successful in achieving planned oversight goals. In a recent webinar on this subject, Chaucer Life Sciences, U.S. and European based experts specializing in the delivery and adoption of new ways of working in life sciences, outlined some key points to think about when preparing for the upcoming changes, and how technology can speed the necessary work to support the new addendum.  There are 5 critical steps Chaucer takes when establishing a strong vendor oversight practice:

1. Assess current oversight activities
2. Identify gaps in evidence / documentation
3. Prioritize risk areas
4. Plan activities to develop compliance to oversight
5. Carry out remediation

In addition to Chaucer’s advice in planning and preparing for implementation, the webinar identified key business value that can be delivered by software, such as Comprehend’s solutions for CRO Oversight, designed to support requirements in ICH E6 (R2) such as:

• Improve cycle time with continuous enrollment funnel management and real-time monitoring of site performance
• Reduce costs with automated outlier identification for proper resource allocation and focus
• Minimize risk through prebuilt KPIs, threshold identifiers, expert process, and real-time data harmonization

Chaucer described “compliance to risk management practices” as an area the addendum focuses on.  Some additional key requirements we suggest that organizations will now need to consider include:

1. The requirement to adopt risk management principles.
2. Managing and controlling significant non-compliance through improved focus on human subject protection, root cause analysis and proper corrective actions.
3. The adoption of a new framework to encourage technology to help identify, clarify and manage ambiguities in compliance requirements. The new framework requires maintaining validity, longevity, fidelity, and auditability of trial data in the new technology.
4. Increased and enhanced oversight of CROs and sponsors by investigators to uphold and maintain quality standards.
5. Sponsors are required to demonstrate oversight of tasks delegated to CROs.

Many organizations today rely on antiquated, manual processes and stale data to manage risk, and they realize that they will now face severe consequences if they do not address this new addendum. More than 83% of CRO Oversight Benchmark Survey respondents claimed that real-time data access and transparency were critically important to them, but many were still working from week-old data – requiring significant time, effort and cost to maintain visibility and proper reporting.

According to various experts, traditional risk-based monitoring software solutions that focus on 100% source data verification (SDV) in monitoring, and ‘retraining of sites’ when issues are detected, are not enough to satisfy these guidelines. As well, processes and tools that cannot easily harmonize data across multiple disparate sources present challenges to sponsors and CROs who depend on full visibility across systems and portfolios to be able to satisfy their quality management and oversight requirements.

With this in mind, Chaucer Life sciences proposed a number of Best Practice steps to prepare for and confidently address the new guidelines:

1. Interpret.  Every company needs to initially interpret how the guidelines apply to their business and processes
2. Assess.  Examine current practices to leverage what’s already been done and find where gaps exist
3. Prioritize.  Focus on the most critical gaps using historical data and a risk-based approach
4. Implement.  Execute on the critical gaps, applying expertise and knowledge of industry consortiums to minimize effort and maximize results

Chaucer’s Vendor Engagement and Oversight (VEO) approach ensures a reliable method and process to address the guideline requirements for Oversight.  This approach engages both vendor and sponsor activities from initial awareness through and including inspection readiness, compliance reporting and auditing, and documentation.

With their Vendor Engagement HealthCheck, Chaucer is able to graphically identify areas of highest criticality, helping sponsors reduce time and effort to pinpoint at-risk oversight activities.  One of the requirements in the new guidelines is designed to encourage sponsors and CROs to apply innovative technology to minimize errors and their downline effects.  Chaucer emphasized that much of their approach is greatly enhanced by the inclusion of technology. A solution that can aggregate data from multiple sources to obtain timely and trusted results for the Chaucer assessments.

Finding the right direction and solution to ICH E6 (R2) will be different for every organization, but in order to speed results while maintaining top quality, sponsors and CROs will need to automate their oversight processes. In the 2016 CRO Oversight Benchmark Survey, sponsors set out the key requirements to improve their CRO relationships:

Interestingly, the majority of executives surveyed in the report claimed their top priority in order to improve milestone achievement was monitoring & alerting.  Automated monitoring can continuously review site-specific data and then notify stakeholders upon outliers or breaches to help organizations stay ahead of key risk areas and minimize disruption and costly effects to the trial.  Tasks and collaboration capabilities can ensure everyone is on the same page and working to meet the quality agreement, oversight plan, and milestone timing.

Determining the reason for a study delay depends much on understanding site performance, which can be accomplished through KPIs at both the study and site levels where bottlenecks can be identified and rectified.

With the upcoming release of this addendum to the global GCP Guidelines, 100% of sponsors and CROs are re-evaluating their processes, systems, and methods to address ICH E6 (R2).  It’s too early to know how much will need to be changed internally, but these organizations can get a jump on the preparations by following best practice process advice from Chaucer Life Sciences and learning about CRO oversight automation from Comprehend Systems.  In order to achieve continuous CRO Oversight, organizations need to take advantage of Best Practice methods and software solutions specifically designed for CRO Oversight that together allow an organization to understand where there may be delays such that they can course correct in a timely fashion to achieve critical milestones while successfully addressing ICH E6 (R2).]

Interested in learning more?

Watch our webinar on CRO Oversight Series, Part 2: ICH E6(R2) Best Practice Implementation and Technology Solutions for Pending Updates to Global GCP Guidelines

or Check out the CRO Oversight Survey Infographic