RWE and Risk: A Primer

RWE and Risk: A Primer

Balancing the Demand for Deep Data with Patient Privacy

As pharma companies have become more sophisticated in their use of real-world evidence (RWE), they have moved beyond standard datasets from vendors to access a deeper and wider variety of datasets, often working in partnership with local health systems. Indeed, leading pharma companies have built comprehensive networks and data platforms can that provide a shared understanding to teams across the organization about the reality of what is happening in healthcare. The increasing number and variety of datasets analyzed — including novel sources from social media through to medical imaging — are delivering ground-breaking insights.

However, accessing a growing range of data sources will necessitate new capabilities, including the critical need to protect patient privacy. Many pharma companies cite protecting privacy as one of their primary imperatives in building RWE into their capabilities, but also a key barrier to making progress. Real-world data (RWD) is patient-level data drawn from a variety of sources that all contain varying amounts of protected health information (PHI). Removal of PHI is a critical first step to using this data in RWE analysis. The challenge is how to effectively anonymize the data without diminishing data quality in an exponentially increasing number of contexts.

Fortunately, new software enabled capabilities now exist to address this urgent challenge. Best practice approaches and guidelines have emerged advocating for a risk-based approach to  de-identification in order to balance the competing goals of anonymity and quality. Levering an automated de-identification process that uses a risk-based methodology ensures a continuous — and legally compliant — flow of data for RWE analysis.

In this primer, we describe the techniques, software platforms and highlight example use cases of how pharma companies can take both sustainable and secure approaches to access new datasets and build RWE data networks.

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Archiving / Destroying

Are you unleashing the full value of data you retain?

Your Challenges

Do you need help...

OUR SOLUTION

Value Retention

Client Success

Client: Comcast

Situation: California’s Consumer Privacy Act inspired Comcast to evolve the way in which they protect the privacy of customers who consent to share personal information with them.

Evaluating

Are you achieving intended outcomes from data?

Your Challenge

Do you need help...

OUR SOLUTION

Unbiased Results

Client Success

Client: Integrate.ai

Situation: Integrate.ai’s AI-powered tech helps clients improve their online experience by sharing signals about website visitor intent. They wanted to ensure privacy remained fully protected within the machine learning / AI context that produces these signals.

Accessing

Do the right people have the right data?

Your Challenges

Do you need help...

OUR SOLUTION

Usable and Reusable Data

Client Success

Client: Novartis

Situation: Novartis’ digital transformation in drug R&D drives their need to maximize value from vast stores of clinical study data for critical internal research enabled by their data42 platform.

 

Maintaining

Are you empowering people to safely leverage trusted data?

Your Challenges

Do you need help...

OUR SOLUTION

Security / compliance efficiency

CLIENT SUCCESS

Client: ASCO’s CancerLinQ

Situation: CancerLinQ™, a subsidiary of American Society of Clinical Oncology, is a rapid learning healthcare system that helps oncologists aggregate and analyze data on cancer patients to improve care. To achieve this goal, they must de-identify patient data provided by subscribing practices across the U.S.

 

Acquiring / Collecting

Are you acquiring the right data? Do you have appropriate consent?

Your Challenge

Do you need help...

OUR SOLUTIONS

Consent / Contracting strategy

Client Success

Client: IQVIA

Situation: Needed to ensure the primary market research process was fully compliant with internal policies and regulations such as GDPR. 

 

Planning

Are You Effectively Planning for Success?

Your Challenges

Do you need help...

OUR SOLUTION

Build privacy in by design

Client Success

Client: Nuance

Situation: Needed to enable AI-driven product innovation with a defensible governance program for the safe and responsible use
of voice-to-text data under Shrems II.

 

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