Responsible Data Return in Rare Disease Clinical Trials: What Sponsors Need to Know

Returning patient data in clinical trials is becoming recognized as an essential component of patient-centric research. In rare disease studies, it is particularly important. Patients with rare diseases often have limited access to information about their own health and the progression of their condition. When implemented responsibly, returning results can empower patients, promote transparency and enhance continuity of care. At the same time, sponsors must navigate complex considerations related to privacy, informed consent, data interpretation and long-term accessibility.

In this webinar, expert speakers will discuss operational, ethical and regulatory factors that shape, and sometimes drive, effective data-return strategies in rare disease trials. The featured speakers will cover participants’ rights, informed consent integration and approaches for protecting privacy and data integrity. Attendees will also learn tips for presenting results clearly to prevent misinterpretation and support patient understanding, along with strategies for building flexibility into data-return processes to accommodate evolving patient preferences.

By the end of the session, attendees will have a better understanding of the complex considerations surrounding responsibly returning individual patient data to strengthen patient engagement while meeting ethical and regulatory expectations.

Register for this webinar to learn how sponsors can implement responsible patient data return practices in rare disease clinical trials.

Speakers

Angi Robinson, Senior Vice President, Specialty Areas, Premier Research

Angi Robinson has been designing and conducting specialty studies, including pediatric and rare disease studies, for more than 24 years. She has provided strategy, oversight and full management support for rare disease studies at Premier Research for over 20 years, including global programs in ultra-rare indications.

Ms. Robinson has a thorough understanding of drug development with extensive supervisory experience and management in conducting registrational-enabling clinical trials for orphan drugs. Ms. Robinson’s experience encompasses complex study designs such as PK/PD and adaptive design, and she has worked with products granted expedited designations by the agencies, including FDA Fast Track, Breakthrough Therapy, RMAT and PRIME designations, as well as advanced medicines. Specifically in orphan drugs, Ms. Robinson has supported nine products resulting in FDA and EMA approval.

Ms. Robinson earned a Bachelor’s degree in Cell and Molecular Biology from Tulane University in New Orleans, LA.

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Victoria Watts, Vice President, Compliance Officer, Premier Research

Victoria Watts joined Premier Research in February 2018. She oversees the data protection strategy and program implementation to ensure compliance with global privacy laws, as well as the company’s quality and compliance divisions. Prior to moving into data protection, she served as a senior compliance manager at Barloworld, a South African multinational company, where she developed its anti-bribery, ethics and competition law compliance programs.

A trained lawyer with a specialization in data protection, Victoria earned a Master of Studies in Modern History from the University of Oxford and later a Law degree from the University of Law. She later obtained a Practitioner’s Certificate in Data Protection and qualifications from the International Association of Privacy Professionals, as a Certified Information Privacy Technologist and Certified Information Privacy Professional (Europe).

In July 2025, Ms. Watts was elected as the first Chairman of the COSUP, which is the supervisory body that oversees the operation of the EUCROF GDPR Code of Conduct for Service Providers in Clinical Research. The Code is the first transnational GDPR Code of Conduct in the area of health and clinical research, and as Chairman, Ms. Watts plays a key role in overseeing the co-regulatory powers of the COSUP in the field of data protection in clinical research.

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