A digital illustration representing the complexities of GDPR compliance in clinical trials.

GDPR: How to Navigate the Data Privacy Maze in Global Clinical Trials

Reese Marlowe in Law & Justice December 2025 • 3 min read.

"Understanding the Impact of EU's GDPR on Research and Patient Consent Across Borders"

The enforcement of the EU's General Data Protection Regulation (GDPR) has sent ripples across the globe, reaching as far as Australia. These regulations have shifted control of personal data back to individuals, impacting how data, even data previously consented to for clinical trials, is handled.

Experts like Anastassia Negrouk and Denis Lacombe have pointed out inconsistencies and uncertainties in GDPR guidance. Active clinical trials involving EU participants face challenges in meeting GDPR compliance, creating concerns about the continuation and validity of ongoing research.

This article explores how GDPR affects global clinical trials, focusing on patient consent, data management, and the need for clear guidelines to ensure research integrity and international collaboration.

Decoding GDPR's Impact on Clinical Trials: Why It Matters

A digital illustration representing the complexities of GDPR compliance in clinical trials.

GDPR's reach extends beyond Europe, affecting how researchers worldwide collect, store, and use patient data in clinical trials. This regulation gives individuals more control over their personal data, impacting how consent is obtained and managed throughout a trial's duration.

One of the most pressing issues is clarifying GDPR compliance for ongoing clinical trials involving EU participants. Researchers are concerned about potential disruptions due to strict consent requirements and the challenges of adapting to these new regulations.

Annual Re-Consenting: Repeatedly seeking consent from participants can strain resources and create logistical challenges.
Participant Dropouts: More complex consent processes may lead to participants withdrawing from studies.
Data Storage Redesign: Providing participants with unfettered data access requires significant changes to data storage infrastructure.

Another concern is whether initial consent covers secondary analyses or future unspecified research. Some interpretations suggest that additional consent is needed for any use of data beyond the primary trial endpoint. This could limit academic research and the use of clinical outcomes data.

Navigating the Future: Collaboration and Clear Guidelines

EU collaborators play a crucial role in global clinical research. However, increased financial risk aversion may deter trial groups and industry from conducting studies involving EU participants, highlighting the need for solutions that streamline the process.

While improving the experience of clinical trial participants is a shared goal, regulations should not hinder international collaboration. The research community needs clear, unambiguous, and practical guidelines to navigate GDPR compliance effectively.

The path forward requires open communication, collaboration, and the development of compliance strategies that respect individual rights while preserving the integrity and progress of global clinical research. Compliance guidelines are paramount.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1016/s1470-2045(18)30696-x, Alternate LINK

Title: Gdpr—Not Just An Eu Regulation?

Subject: Oncology

Journal: The Lancet Oncology

Publisher: Elsevier BV

Authors: Scott Williams

Published: 2018-10-01

Everything You Need To Know

What is the General Data Protection Regulation (GDPR), and what is its primary purpose?

The General Data Protection Regulation (GDPR) is a comprehensive data privacy law established by the European Union (EU). It grants individuals greater control over their personal data, including the right to access, rectify, and erase it. This has significant implications for clinical trials because it dictates how patient data is collected, stored, and used globally, not just within Europe. GDPR's impact is far-reaching, affecting how researchers worldwide manage patient consent and data throughout a trial's lifecycle.

Why is GDPR significant for clinical trials?

GDPR is important because it shifts the control of personal data back to individuals. In the context of clinical trials, this means that patient consent becomes a central focus. Researchers must obtain explicit consent, and this consent must be ongoing, transparent, and easily withdrawn. The potential implications are considerable, including the need for annual re-consenting, potential participant dropouts due to complex consent processes, and the requirement to redesign data storage to provide unfettered data access to participants.

How does GDPR specifically affect the conduct of clinical trials?

GDPR affects clinical trials by introducing strict requirements for data handling. This includes the need for informed consent, which must be specific and documented. Researchers need to clarify how patient data will be used, stored, and protected. A key challenge is ensuring that initial consent covers secondary analyses or future research. Some interpretations suggest that additional consent is needed for any use of data beyond the primary trial endpoint, which could limit research scope. Compliance demands significant changes to data management, potentially straining resources and impacting research timelines.

What are the main challenges researchers encounter due to GDPR regulations?

The main challenges researchers face due to GDPR are related to patient consent and data management. Obtaining and managing patient consent under GDPR is complex, especially when clinical trials involve EU participants. Specific issues include the need for annual re-consenting, which can be resource-intensive. Further challenges arise from providing participants with unfettered data access, which necessitates changes to data storage infrastructure. These challenges increase the risk of participant dropouts and can impact the validity and continuity of ongoing clinical trials.

What are the key steps needed to ensure compliance with GDPR in global clinical trials?

To navigate the complexities of GDPR, researchers need clear guidelines and international collaboration. Clarification on GDPR compliance for ongoing clinical trials is essential, especially for studies involving EU participants. Harmonization of data protection standards and international cooperation can help streamline the process. Furthermore, increased financial risk aversion may deter trial groups and industry from conducting studies involving EU participants, so solutions are needed to reduce these risks and encourage collaboration. Expert opinions are also needed to address the uncertainty surrounding GDPR guidance to ensure research integrity and facilitate global clinical trials.