Achieving Clinical Trials Transparency

Achieving Clinical Trials Transparency

Recent policy changes by Europe’s regulatory authority for drugs and devices has rekindled the pharmaceutical industry’s focus on clinical trials transparency. While there have been many initiatives to enhance openness in drug trials, the European Medicine Agency’s (EMA) requirement to make a trial’s clinical study report (CSR) publicly available is seen as a revolutionary move to boost public trust in the drug approvals process.

As the comprehensive report that details the protocol and results of a clinical trial, the CSR can contain highly sensitive health information about the study’s participants — placing the issue of patient privacy front and center. It also leaves many in the biopharmaceutical community wondering how to meet the EMA’s new transparency requirement while remaining compliant with privacy legislation and protecting their own confidential information.

How biopharmaceutical companies choose to anonymize their clinical trial data and reports have serious implications for transparency and their ability to leverage data for secondary uses. On the surface, different approaches to protecting the privacy of trial participants may appear to be equally sound, but they can have vastly different results when it comes to the usefulness of the anonymized content for subsequent analysis.

Understanding the drawbacks and benefits of the different methods for anonymization can help pharma companies better position themselves for the future. By aligning with best practice guidelines, they will not only be able to meet new transparency mandates but do so while complying with privacy regulations and maximizing the quality of data that can be shared for secondary purposes.

Make sure to download your copy of Achieving Clinical Trials Transparency today to learn how your organization can balance the demands and risks of data sharing.

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Archiving / Destroying

Are you unleashing the full value of data you retain?

Your Challenges

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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

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OUR SOLUTION

Unbiased Results

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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?

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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?

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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.

 

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

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OUR SOLUTIONS

Consent / Contracting strategy

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Client: IQVIA

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

 

Planning

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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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