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Article Blog December 17, 2018 4 minute read

89% of Sponsors Say They Need Help Aligning with ICH E6(R2)

If you’ve watched any of Comprehend’s webinars about improving clinical trial performance and reducing risk, you know that we’re fans of QuickPolls. While not scientific, these questionnaires provide valuable insights into what our webinar attendees think about different issues.

In a recent webinar about ICH E6(R2) compliance, for example, we found that the vast majority of sponsors need help aligning with the latest guidance related to good clinical practice (GCP).

Just 11% of our webinar attendees were satisfied with the process changes they’ve implemented since ICH E6(R2) guidelines were introduced in 2016. The rest of the respondents—89%—were either unhappy with changes they’ve made or were still in a pre-implementation stage.

December Webinar - Poll 1

The updated ICH E6(R2) guidelines are, in large part, a response to technology advances that have occurred since 1996, when the original GCP guidance was published. The latest recommendations focus on risk-based, data-driven approaches to quality management and clinical trial monitoring, with the ultimate goal of increasing efficiencies while ensuring that patients are protected and trial results are reliable.

Sponsors should be particularly aware of the fact that the new ICH E6(R2) guidelines put the burden of data quality and integrity squarely on their shoulders, regardless of whether or not they hire one or more CROs to conduct the clinical research.

Your Partnerships Are More Important than Ever

Under the new ICH E6(R2) guidelines, sponsors that use CROs are challenged to conduct oversight in a way that demonstrates engagement and awareness without duplicating efforts. To accomplish this, sponsors and CROs must collaborate to define roles and responsibilities, choose relevant metrics, and work toward greater data access, transparency, and automation.

In the first part of our webinar, Karen McCarthy Schau—Director Consulting Services, Health & Life Sciences at CGI—discusses how to align with partners on an ICH E6(R2)-based strategy. She stresses the value of face-to-face workshops in the early planning stages, along with open communication on an ongoing basis.

Karen believes that one of the most important ways of establishing trust is for sponsors and CROs to build a responsibility assignment matrix (RACI) together. Using agreed-upon timing and escalation pathways, instead of gotchas and other blame-game tactics, goes a long way toward strengthening relationships and achieving the goals set forward by ICH E6(R2).

Streamline Your Workflows with Metrics and Measurement

Sponsors and CROs must also reach agreement on metrics, including how they’ll be measured. In Karen’s presentation, she goes over some of the questions you need to ask to get everyone on the same page:

    <li;”>Which data points have the greatest impact on decision-making?

  • What are the data collection parameters?
  • Where is the data coming from and who owns it?
  • Who’s responsible for measuring and who can implement a change?
  • What’s the purpose of each metric?
  • What does each metric unit mean?

Once these rules are defined, sponsors and CROs must avoid duplicative efforts by sticking to what they’re responsible for acting on, versus what’s just reported as an FYI. The use of data connectors and structured transfers, instead of spreadsheets, can facilitate this by making data available in real time and by enabling the creation of role-based dashboards for key stakeholders.

A Real-World Success Story

After Karen’s presentation, I took the audience through a customer case study that shows how a sponsor, guided by ICH E6(R2), strengthened its CRO relationships. The sponsor, a midmarket biopharmaceutical company, was looking for a more collaborative environment and wanted the ability to view data and analyze data in a more timely manner.

As I was going through the case study, I asked attendees to pick their top challenge in putting ICH E6(R2) guidelines into practice. Defined metrics and transparency were the biggest issues according to the QuickPoll, followed closely by process and change management improvements.

December Webinar - Poll 2

Our case study client faced all of these challenges, which is why they turned to Comprehend for help. Data access and transparency were both limited, and any data the client did get to see was already two weeks to a month old. The lack of defined metrics led to incomplete and inconsistent data across four CROs, and manual data entry processes were causing unacceptable data inaccuracies.

The solution provided this client consisted of three key components:

  1. A single clinical data repository
  2. Automated KPI monitoring with CROs
  3. Daily view of critical data quality analytics

In the webinar I outline best practices and lessons learned, including why change management matters, how focusing on small wins leads to greater adoption, and why KPI/KRI customization isn’t always necessary use of resources.

Using Comprehend solutions—including ClinOps Insights, CRO Oversight & Collaboration, and Centralized Monitoring—the sponsor gained timely, standardized access to operational data, improved data quality across sites and studies, and shortened response times with collaborative task management tools, such as automated alerts. In the end, the sponsor achieved better compliance with ICH E6(R2) and improved the quality of all the trials in its portfolio.

To learn more about how Comprehend can help you get better aligned with ICH E6(R2), watch our webinar on demand now. Or contact us by emailing, calling 650-521-5449, or requesting a demo.