臨床試験デザインの標準化で大きな夢を描く - あるバイオ製薬会社のメタデータ自動化への道のり

They realized that to revolutionize the study build process, they had to go back to day one of study design; to the schedule of assessments, or as they call it, the ‘heartbeat’ of any study.

Their existing process for creating and programming the schedule was manual and inefficient. But what if they could have a schedule of assessments and associated content that could be standardized all the way through to submission?

This is where we came in. Our many years of supporting clients to implement standardization and build studies meant we could guide them towards their goal.

Our first step was to address the following questions:

• What legacy information is in place, and what can be used?
• Could we reuse or repurpose existing content?
• What content needs to be created from scratch?
• What standards are relevant?
• What electronic data capture (EDC) systems are in place, and how can we accommodate features that are unique to the EDC?
• What other systems do we need to link to?
• How should they be governed in a way that’s not restrictive to the process?
• How much could be automated?
• What could be done to get a ‘quick win’?

These questions required the organization to take a step back and assess the true state of internal standards. While there were standards in place, there were inconsistencies. They were using many different ways of asking the same questions in case report forms across studies. These inconsistencies created a challenge when it came to data collection and processing down the line.

We helped them create new, relevant content, within the ryze clinical metadata repository (CMDR), now part of the Pinnacle 21 (P21) platform. We developed a new change management process and produced new SOPs to guide their team on a new way of working.

But implementing the CMDR was just one part of it; we also considered how we might extend and enhance our platform to help the organization achieve their ambitious goals. How could we adapt to meet their needs, and the needs of the industry as a whole?

For this biopharma, and the wider industry, third-party data is becoming a key resource. Third party or non-EDC data is often far more complicated than data collected via EDC. How could they standardize that third party data to get it into a consistent format, for it to be part of their SDTM generation downstream?

The platform’s ability to integrate, both with their internal systems – such as their EDC, eCOA and ePRO platforms, and other third-party systems – meant they could create custom CRF visualisations, as well as allowing them to gather and standardize third-party data.

As well as using our CMDR for case report form design and creating standards, they use P21’s Enterprise platform for study validation. They’re able to easily design and store study specifications in one place that is accessible by vendors, so they know CROs are collecting data in alignment with their study specifications. Then they simply validate the data to ensure it meets their requirements before submission.

Within any study team, there are various stakeholders with different priorities – all needing different things from a study. One big challenge was bringing together every possible stakeholder in the study process to ensure these needs were met.

This is where this organization’s teamwork and agile mindset made all the difference. Everybody in the programme, from their executive leadership team to their steer committee, supported the journey to standardization.

All those stakeholders essentially wanted the same thing – a more straightforward way to collaborate and build, for study success. And by being transparent upfront, communicating regularly, and allowing time for stakeholders to ‘buy in’, they were able to meet the ambitious targets they set out to achieve.

The project took around ten months from the initial workshop to CMDR go-live. Even in the first few months of CMDR implementation, the organization was seeing a difference. From study to study, content reuse increased and time to set up studies decreased by 85%, and time to complete the first study draft review decreased by 50%.

Pinnacle21(以下P21)は、臨床試験のエンドツーエンドプロセスを最適化する次世代クラウドスイートです。効率性の向上、データ品質の最大化、関係者間のデータフローの改善が指先ひとつで実現します。

• Standardize and reuse content in your Clinical Metadata Repository
• Design and build EDC studies in under six weeks
• Get quality third-party data insights, on time
• 臨床試験提出データのスピードと質の向上

Click here for more information about Pinnacle 21 Clinical Data Management and Automation Suite.