Accelerate Clinical Trials with an External Control Arm Built on extreme quality anonymized data
Harness the power of VEIL.AI to create robust external control arms, ensuring data privacy and enhancing research integrity. Discover how our advanced anonymization technology transforms clinical trial data, driving innovation and accelerating medical breakthroughs.
This case study demonstrates:
- How anonymized data can be of such a high quality that the same conclusions can be drawn from it, as from traditional pseudonymized, individual-level research data
- How sensitive data can be anonymized, after which it can be transferred to another country to be enriched and further utilized
This is a significant achievement. In our study, we could draw the same conclusions from anonymized data as from traditional pseudonymized, individual-level research data.
Jussi Leinonen,
Strategic Project Lead
Bayer
BACKGROUND AND TARGETS
Global life science company Bayer carried out a three-year multi-million-euro development project called Future Clinical Trials (FCT), which utilized AI-enhanced next-generation anonymization technology from VEIL.AI.
The international project was aiming to find ways to:
speed up clinical trials
reduce drug’s time to market
increase patient safety
reduce costs
Why external arms are used?
If there is high-quality anonymized data available, part of the control patient group could be replaced in some instances with an external control arm. This can have many positive impacts like increasing efficiency, reducing delays, speeding up a drug's time-to-market and lowering costs in the evaluation of new therapies.
STEPS TO BUILD AN EXTERNAL CONTROL ARM
DATA FROM REGISTER HOLDERS
When talking about external control arms, Bayer wanted to create a methodology for providing virtual or synthetic controls for clinical trials based on RWD and legacy clinical trial data.
The FCT project was implemented in Finland, which has good health data registers and the first legislation for secondary use of health data introduced in Europe. The name of the health data permit authority is Findata.
The new data needed for Bayer's external control group was collected from national registers and databases directly into Findata's secure operating environment, where it was cleaned, checked and processed.
HIGH-QUALITY DATA ANONYMIZATION
After that VEIL.AI anonymized the pseudonymized data with next-generation anonymization technology with very high quality. In fact, the next-generation anonymized data was of such high quality that the same conclusions could be drawn from it as from traditional, pseudonymous individual-level research data.
VERIFICATION OF ANONYMITY BEFORE DATA RELEASE
So now Bayer had new high-quality anonymized register data in Findata's data secure environment. But how can an authority or a Data Privacy Officer (DPO) know that an anonymized dataset is really anonymous? How can anonymity be verified before anonymous data is released to be transferred to another country?
VEIL.AI has also solved this issue; VEIL.AI has created a protocol with which authorities and DPO’s can verify the anonymity of datasets that have gone through the anonymization process. The analysis is a transparent way to provide strong evidence of privacy protection before releasing the anonymized data for further use and helps to document what has been done during the anonymization process.
AUTHORITY CONSENTS TO THE TRANSFER OF ANONYMIZED DATA TO ANOTHER COUNTRY
After Findata was able to verify the anonymity of the dataset, it gave consent for Bayer to export the verified anonymous data to Bayer’s own secure data science environment.
In this way, Bayer received new high-quality anonymized data in their own Data Science environment which opened up great new possibilities for further enrichment and utilization of data, such as:
- merging the anonymized data with legacy RCT data
- getting more anonymized RWD and RCT data
- data augmentation to extend the follow-up time and improve the efficiency of clinical trials
RE-USE OF BAYER’S LEGACY DATA WITH EXTERNAL PARTNERS
Another big topic was how to enable efficient data sharing and re-use of Bayer's own legacy RCT data with external partners. Re-use of legacy data provides huge opportunities and its value can increase drastically.
If the data is anonymized with high quality it can naturally also be re-used internally and in addition, collaboration and co-development with external partners is much easier.
In the FCT project, indication specific harmonized and curated datasets were created in Bayer’s data science environment. VEIL.AI's AI-enhanced next-generation anonymization technology enabled the re-use of legacy data. The anonymization results were excellent.
If legacy data is anonymized, an external partner can be granted access to the data on organization’s own server without having to send the data anywhere (outside the organization).
NEXT-GENERATION ANONYMIZATION & PERSPECTIVES FOR THE FUTURE
Bayer identified various different use case opportunities for anonymization, related to both focus areas (real-world-evidence and randomized clinical trials).
The aim is to move towards defined standards and continuous anonymization capability included in data science platforms and workflows.
"Data Scientists in data driven organizations need good data to practice high-quality data science. Continuous next-generation anonymization capability can help to do things that would otherwise not be possible." - said Jussi Leinonen, Strategic Project Lead at Bayer
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