Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help
A conversation with Tashan Mistree, co-lead for ICH E6 and E8 work, TransCelerate BioPharma
If you’ve begun combing through the new ICH GCP E6(R3) guidelines to understand how the updates will affect your clinical research practices and feel just a little lost or overwhelmed, you’ve got help.
TransCelerate BioPharma, in a partnership with the Association of Clinical Research Organizations (ACRO), has designed and released 13 tools to support E6(R3) adoption across six focus areas:
- Trial design
- Risk proportionality
- Risk management (with ACRO)
- Data governance (with ACRO)
- Monitoring
- Investigators
TransCelerate’s co-lead on this effort, Tashan Mistree, shares how and why these free tools for pharma companies and their supporting stakeholders were developed.
Clinical Leader: Who developed these tools, and why?
Tashan Mistree: The first team came together in 2021 to review ICH E8(R1). We examined the available information, training, and presentations. We also conducted a landscape survey of member companies to understand their implementation status of ICH E8(R1). Responses varied, from those who hadn't considered it yet to those who were more advanced. Some member companies have definitions for certain terminologies, while others don't. Some have integrated it into their processes and SOPs, while others haven't.
Again, with the ICH E6(R2) revision, we recognized the struggles and challenges that member companies faced in implementing and interpreting the guidance. When a company has a single way of interpreting what could be very gray areas in guidance, our tools can enhance the embedding of the guidance. With them, people have already come together to realize what the changes mean, so interpreting it together is a lot less daunting.
Once the draft guidance for ICH E6(R3) was out for public consultation, we considered what solutions were needed. ICH E8(R1) was revolutionary because the ICH working group laid out fundamental principles that you now see throughout ICH E6(R3). ICH E6(R3) is operational, while ICH E8(R1) is principle-oriented, reintroducing ideas that are now much more solidified or codified within the guidance. Those principles of critical thinking — quality by design, critical to quality factors, fit for purpose, and growing a quality culture — were laid out in ICH E8(R1). Then in ICH E6(R3), you see the opportunities to operationalize those principles, whether it's for the investigators, sponsors, or even IRBs.
GCP is unique in that it has no single way of interpreting or doing something. That's where our solutions came in.
What were the concerns about the new guidelines within the TransCelerate membership, and how did those inform the development of these tools?
While topic areas like trial design, monitoring, risk management and investigator responsibilities are familiar, we knew that the areas of change, including the newer additions of data governance and risk proportionality, would require more support to operationalize. For example, for data governance, the tools and solutions support GCP stakeholders with compliance, data quality, and decision-making, as well as ensuring fit for purpose systems and processes across the clinical research landscape.
Sponsors can't all do it the same way. We don't want to do it the same way, but you do need to follow through with the same principles. That's where the tools and solutions come in — to help you apply those principles and operational aspects in compliance with ICH E6(R3).
You covered the ICH updates and shared some of these tools during a presentation at the SCOPE Summit. What were attendees most interested in?
The data governance solutions have generated the most interest, as a new section in the ICH E6 guidelines, as well as providing guidance for sponsors and investigators on managing data integrity, traceability, and security. This starts with definitions and guidance on building a data governance framework using the solutions we have developed. Other tools include the technology framework tool that explains the computer system requirements as laid out in ICH E6(R3), the data flow template that helps sponsors map out the relevant data flow between different systems and collection tools, the data matrix template that establishes data provenance and collection methods, enabling review and analysis, and, finally, the safeguarding blinding considerations tool that allows one to ask the right questions around blinding.
Overall, for all the tools, the vibe has been inquisitive. You don't know what you don't know, and so people are just starting to see how they can utilize what's out there versus re-creating the wheel. And the nice part about TransCelerate as a platform is it leads to people linking into different tools and using the knowledge that's out there.
Finally, where can people go to find these tools? And what tips do you have for users just getting acquainted?
All 13 tools are available on the TransCelerate website in the ICH E6 Asset Library. An overview of the ICH E6(R3) and ICH E8(R1) solutions is here. Different companies are at different places when they're adopting guidelines. Some companies may be ahead in some areas, others are not. Therefore, the solutions enable you to bridge that gap. They're also a great way for training individuals across clinical research.
About The Expert:
Tashan Mistree is an experienced professional with over 14 years in quality assurance, quality management, and auditing. In her previous role as head of audit conduct in clinical quality assurance, she led the execution of both internal and external audit programs. Tashan's work passions include embedding critical concepts such as quality risk management, critical thinking, and quality by design into processes to ensure fit-for-purpose clinical trials. Currently, Tashan co-leads the TransCelerate workstreams for ICH E6 R3 and E8 R1, which focus on the challenges in implementing and operationalizing new guidance revisions by developing solutions to support stakeholders.