TrialAssure (a software provider specializing in clinical trial disclosure, data sharing, and transparency) has announced that biosimulation specialist Certara will use the company’s Anonymize software to anonymize clinical data.
The Anonymize software is designed to provide advanced anonymization technology for datasets that enables trial sponsors to anonymize all structured clinical trial data, including datasets and tables. The tool reportedly can be configured to meet sponsor specifications, and adjusted to take advantage of machine learning capabilities.
According to Certara, its Synchrogenix regulatory science division will use the Anonymize technology in a software-as-a-service (SaaS) model to provide tech-enabled anonymization service for their client roster of more than 1,650 global biopharmaceutical and biotech companies across 61 countries.
Kelly Vaillant, director of global transparency strategy and compliance for TrialAssure spoke with Outsourcing-Pharma about the Anonymize technology, and how it tackles common challenges associated with anonymizing clinical trial data.
OSP: Could you please tell us a bit about TrialAssure—who you are, what you do, key capabilities/specialties, and what sets you apart from the competition?
KV: TrialAssure is a global, award-winning clinical trial and human health data transparency suite. TrialAssure helps meet regulatory compliance goals through a flexible, scalable, and streamlined platform that supports clinical trial registration, trial results disclosure, data sharing, data and document anonymization, and patient engagement activities.
What sets TrialAssure apart from our competitors is we are one of the only systems to offer all transparency solutions in one cloud-ready platform. Additionally, our system allows for anonymization and redaction to be applied – at the same time – to documents via a single rule set.
We recognize there is often the need to work in parallel, fulfilling the needs of multiple health authorities or data requestors and our document anonymization software is able to utilize a subset of rules defined for anonymizing datasets, enhancing consistency of anonymization between datasets and documents.
OSP: Then could you please tell us how the Anonymize technology works, and how Certara will put the technology to use?
KV: TrialAssure Anonymize for Data allows sponsors to anonymize or redact all structured clinical trial data, including datasets and tables. It’s entirely configurable to sponsor specifications and architected to take advantage of machine learning capabilities, and it has proven to be up to 80% more efficient than traditional anonymization tools and techniques.
We have created a simple design and rule builder function, allowing users to build a library of custom, reusable variables and reapply the same anonymization rules across studies. This saves valuable time and resources, especially with larger drug development pipelines where multiple studies share the same variables. As the library continually develops, the process becomes more efficient.
Once a sponsor determines which data fields to anonymize, the software will perform an analysis and assign a risk score. This analysis can be saved and replicated for future use, making the decision-making process easier.
Certara’s regulatory science division, Synchrogenix, will use this to support their tech-enabled solutions for redaction and patient engagement.
OSP: Specifically, what are some of the key challenges with anonymizing clinical trial data, and how does the Anonymize help deal with some of those obstacles?
KV: The goal and frankly the challenge for any anonymization request is to properly balance the need to protect the patient or trial participant’s privacy with the need to maintain a degree of data utility. Anonymization can be complex and an iterative process that requires a specialized technology like TrialAssure’s Anonymize that will allow for rapid processing and includes anonymization reports where risk of re-identification scores are assigned to help find this proper balance.
Also consider, in the last five years alone, we have seen the introduction of numerous country-specific transparency regulations, industry guidelines, and requirements, including EMA Policy 0070 and FDAAA 801 for instance. In the coming years, we can expect even more regulation, like the full implementation of the EU Clinical Trial Regulation and associated Clinical Trial Information System (CTIS) and increased scrutiny and focus on data transparency.
These changing and increasing requirements force sponsors to adapt quickly, especially when it comes to data anonymization. Those who are not able or willing to do so face increased public pressure, the potential of penalties for non-compliance, and issues leveraging advantages that greater transparency can bring.
TrialAssure’s Anonymize platform eases the burden for clinical trial sponsors and offers them a system that is continually updated to take into account changing laws, regulation and guidance.
OSP: Is there anything you’d like to add we didn’t touch upon above about Anonymize, other solutions offered by TrialAssure, etc.?
KV: Our mission is to facilitate transparency for the entire life sciences including the pharmaceutical industry. TrialAssure is dedicated to providing the best end-to-end clinical trial disclosure and data transparency technology, and we are dedicated to helping the industry meet and exceed regulatory compliance standards.
We believe that data transparency advances science and the development of new medicines. As an industry, we have a responsibility and obligation to make information about clinical trials available in a way that protects patients’ privacy while also advancing scientific research. We like to say that #BeTransparent is not just our hashtag, it’s who we are.