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Article Blog April 3, 2018 4 minute read

The Intersection of Study Oversight and ICH E6 (R2)

In a recent Comprehend webinar, “Three Key Ways ICH E6 (R2) Impacts Study Oversight,” CGI’s (formerly Paragon) Karen McCarthy Schau outlined best practice reasons why Sponsors should focus on Study Oversight when addressing ICH E6 guidelines and the upcoming R2 addendum.

ICH E6 (R2) Focus

To frame the discussion, Ms. Schau pointed out three key statements from the addendum on which she would focus:

1. ..encourage implementation of improved and more efficient approaches to clinical trial[s]..

2. ..methods used to assure and control the quality of the trial should be proportionate to the risks..

3. ..the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor..

However, from recent polls of Sponsors, it was noted that while a majority of them believe that Oversight is very important, only a fraction of them feel they are successful at it. In a case study example presented in the webinar, lack of data efficiency, increasing study risk and low team productivity all contributed to that Sponsor’s concern about meeting Oversight objectives and supporting the ICH E6 guidelines.

Building a Trustworthy Relationship

The first Best Practice presented was how Sponsors can build better relationships with their CRO partners. Sponsors who can determine a shared process in their CRO partnerships will have a much better chance of success. In assessing the changes necessary to enact a valuable partnership, Ms. Schau talked about differentiating and evaluating both perception as well as objective data. Focusing on aspects such as transparency, an attitude of openness and sharing, as well as agreement on metrics and outcomes, are clearly important in building trust. While changes may be necessary to jumpstart an existing relationship or establish a new one, ongoing review and assessment are recommended to continue to meet objectives and maintain healthy communications.

How Sharing of Data Improves Outcomes

There are a number of reasons why sharing data between Sponsor and CRO is difficult.  If there is an inability to reconcile dissimilar data formats between systems in a reasonable amount of time, information becomes stale or irrelevant.  There may be an enormous amount of manual time and labor required to evaluate data presented in spreadsheets and then absorbed into Sponsor systems. Pre-processing from either systems or departments may be required before reporting can be provided.  Or, there may be a number of questionable results in the reporting that require deeper investigation before the results can be accepted.

In an example provided by Paragon, now part of CGI, information provided by one system may not have been interpreted correctly by another system. When information is handled in siloes, the reconciliation of that data can become a nightmare for medical monitors trying to determine patient status and investigate issues in a timely manner. There are multiple methods for collecting and managing data, but are they fail-safe? Many Sponsors today still rely on paper-based methods of managing data, or verifying 100% SDV. Ms. Schau recommended that the most reliable method is to be able to see data across all those siloes, apply risk-defined review, and focus on fit-for-purpose critical data supporting safety and quality.

How Metrics Qualify Performance and Conduct

The third Best Practice piece of advice recommends that metrics should be defined by intended purpose as well as by outcomes desired. When working with CROs, Sponsors should identify valuable metrics on operational, study and execution data. This means that their metrics on SOPs would differ from those on protocols, and even more so from study conduct and plans. This helps both Sponsor and CRO view and manage issue resolution, timeliness and escalations. However, in addition to defining metrics by purpose, the quality of the metrics should also be defined, such as clarity of unit measurement, roles, ownership and balance of cost versus time.

Applying Automation to Support a Streamlined Study Oversight Plan

When evaluating these Best Practices, Sponsors can take advantage of automation to speed a data management approach and ensure reliable results for decision-making.  Having the ability to harmonize data from any number of sources, across Sponsor and CRO systems, eliminates both time and manual effort. Sponsors can see and act quickly on issues, delays and process bottlenecks.  Seeing performance and status from a roles-based perspective immediately provides the transparency required to act, while collaborating online with CROs on issues reduces time and cost, and ensures traceability.

Key Takeaways

Some other great advice came out of this webinar, such as:

  • Identify key stakeholders across both Sponsors and CROs and engage them in the process as well as assessment
  • Build relationships based on shared expectations but know that each relationship can be unique
  • Trust but verify – and avoid duplicating partner work
  • Share both successes and areas of improvement to maintain valuable and resilient relationships

Click here to listen to the webinar.

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