Article Blog April 3, 2018

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 compliance.

ICH E6 (R2) Focus
To frame the discussion, Ms. Schau pointed out three key statements from the addendum:

  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, recent polls show that while a majority of sponsors believe that oversight is very important, only a fraction of sponsors feel they are successful at it. In a case study example presented in the webinar, the lack of data efficiency, increasing study risk, and low team productivity all contributed to concerns over meeting oversight objectives and supporting ICH guidelines.

Building a Trustworthy Relationship
To address these concerns, the sponsor in the case study focused on building better relationships with their CRO partners. Sponsors who can establish shared processes in their CRO partnerships will have a much better chance of success. Focusing on aspects such as transparency, openness, and sharing, and agreeing 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 maintain healthy communications and keep clinical trials on track.

How Sharing of Data Improves Outcomes
Sharing data isn’t always easy for sponsors or CROs, especially if they’re using disparate data systems and formats. Spreadsheets are also problematic, because of the amount of time and labor required to evaluate data and import it into the sponsor’s systems. When data is finally reported, it’s either so outdated as to be meaningless, or is so questionable as to require deeper investigation.

In the webinar, Ms. Schau shared an example of how siloed data created a nightmare for medical monitors, who were frustrated in their efforts to determine patient status and investigate issues in a timely manner. Many sponsors rely on paper-based methods of managing data, or verifying 100% SDV, but Ms. Schau recommends visibility across all siloes, applying a risk-defined approach to reviews, and focusing on fit-for-purpose, critical data to support safety and quality.

How Metrics Qualify Performance and Conduct
Another best practice for improving oversight and compliance involves defining metrics 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 metrics on SOPs would differ from metrics on protocols, study conduct, and plans. This helps sponsors and CROs 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, in order to clarify unit measurement, roles, ownership, and balance of cost versus time.

Applying Automation to Support a Streamlined Study Oversight Plan

When evaluating best practices, sponsors should look for solutions that use automation to speed processes, harmonize data across multiple sources, and eliminate manual effort. This will improve decision-making, eliminate delays and duplication, ensure traceability, and reduce risk.

Click here to watch the webinar.

Editor’s Note: Since this blog was first posted in 2017, we’ve made it even easier to manage oversight with the Comprehend Oversight Scorecard. This powerful new data visualization and analytics solution delivers a quick, comprehensive overview of risk, quality, and performance Indicators across a single study or an entire portfolio. With the Oversight Scorecard, users can monitor scores for sites, studies, countries, and vendors—based on pre-selected metrics—to make better, faster decisions.

Download the Oversight Scorecard datasheet

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