Balancing Opportunity and Risk
Real-world data (RWD) has quickly become one of the most valuable tools in clinical research. Information drawn from electronic health records, insurance claims, patient registries, and even wearable devices can provide insights that accelerate drug development and enhance trial outcomes. Regulators, including the FDA and EMA, are increasingly open to and interested in the use of RWD as part of regulatory submissions if collected and used properly.
For sponsors, however, the use of RWD is a double-edged sword. The opportunities are immense, but so are the legal and compliance risks, especially when it comes to patient consent and the considerations and foresight needed in drafting an Informed Consent Form (ICF). Review of (old) ICFs often tell you if your RWD study has a chance to get off the ground.
The Promise of Real-World Data
RWD can strengthen a clinical trial in several ways:
- Smarter trial design: Identifying patient populations more efficiently.
- Improved recruitment: Locating eligible participants faster.
- Augmented evidence: Supplementing trial data with real-world outcomes.
- Regulatory value: Supporting submissions where traditional data sets alone may be insufficient.
By incorporating RWD, sponsors can lower costs, shorten timelines, and generate more robust evidence of safety and efficacy.
The Consent Challenge
The greatest risk with RWD use is not the science, it’s the law. Patient-level health data is often protected by strict privacy regimes (HIPAA in the U.S., GDPR in Europe, PHIPA in Canada, etc.). The linchpin is consent.
- If proper consent was obtained from patients at the time their data was collected, the data may be usable for research.
- If the consent was too narrow, or if it excluded future research altogether, then using that data in a trial could violate privacy law, trigger regulatory scrutiny, and expose the sponsor to liability.
- Even de-identified data carries risks. Regulators increasingly recognize that re-identification is possible with enough data points, meaning sponsors must be cautious in assuming de-identification alone makes data “safe.”
Consequences of Getting It Wrong
Using RWD without the right consent or safeguards can create serious problems:
- Regulatory setbacks: Data may be deemed inadmissible for FDA/EMA review.
- Ethics violations: Institutional Review Boards (IRBs) or Ethics Committees may reject the trial design.
- Legal liability: Sponsors can face fines or lawsuits for privacy breaches.
- Reputational damage: Patients and the public may lose trust in your research program.
In short, failure to address consent can derail the very benefits RWD is meant to deliver.
Why Legal Review Matters
An experienced legal negotiator can help sponsors unlock the present and future value of RWD while mitigating risks by:
- Reviewing consent forms and ensuring they permit future clinical research use.
- Structuring contracts with data providers that allocate responsibility for compliance.
- Advising on de-identification standards and re-identification risks.
- Ensuring compliance with international laws if data is transferred across borders.
Takeaway
Real-world data is reshaping clinical development, but it is not a shortcut. Sponsors must treat patient consent and data rights as seriously as study design and regulatory endpoints. A legal review before incorporating RWD into a clinical trial can ensure the data is both powerful and permissible, protecting your investment and maintaining patient trust.
At ICE Global Consulting we assist in reviewing ICFs to ensure that drafting does not lose sight of the purpose of the Study and the potential for future advancement using that data for RWD in later research. Our team partners with clinical research personnel at both the site and sponsor to align on the main goals of research – advancing product development to provide better outcomes for patients.