Masterarbeit

Pharmaceutical Clinical Data Disclosures: A Comparison of Mandatory Disclosure Programs in Europe, Canada, and the United States of America

Amelia Dungan (2025)

Summary 

Language: English 

Over the past six decades, international health organizations, leading academics, journal editors, regulators, and even pharmaceutical companies have called for the disclosure of clinical data supporting approval of new medicinal products.

Initially, global health organizations and medical journals encouraged voluntary disclosures of data and trial information from pharmaceutical companies, while health authorities and government regulatory bodies relied on general legal authority to disclose selected, heavily redacted clinical data information post-approval. After transparency advocates declared the voluntary disclosures and redacted documents insufficient, legislators and regulators in the EU, the US, and Canada began considering requiring clinical data disclosures as a condition of marketing authorization. 

During the 2010s, regulatory agencies in these three jurisdictions finalized and implemented mandatory disclosure programs for regulated products. In 2016, European Medicines Agency (EMA) implemented Policy 0070, which required sponsors of new drug and biologic applications in Europe to disclose large swaths of clinical trial information contained in marketing applications after-approval. In 2017, U.S. Department of Health and Human Services (HHS) finalized the rules for a 2007 law that required sponsors new drug and biologic applications to the U.S. Food and Drug Administration (FDA) to disclose results, protocols, and statistical analysis plans for those trials on clinicaltrials.gov after a final decision by the Agency. These programs were followed in 2019 by Health Canada’s wide ranging Public Release of Clinical Information (PRCI) program that required that sponsors of any type of drug or device application disclose almost all clinical data submitted to the Agency with little to no redaction. Finally, in 2022, with the start of the European Clinical Trial Regulation (CTR), EMA started disclosing large numbers of clinical trial documents for trials in  in the Clinical Trial Information System (CTIS)’s euclinicaltrials.eu portal. 

In 2025, with all projects operational, an unprecedented amount of previously confidential clinical data is disclosed on multiple government-run websites within a year of marketing authorization. In spite of slightly different regulatory requirements in different jurisdictions, it can be assumed that much of the clinical information is similar. 

This thesis analyzes and compares the clinical disclosures programs mandated by EMA, Health Canada, and the FDA and explores whether the disclosures in their current form are fulfilling the policy goals envisioned when these programs were developed. 

After an introduction to the types of clinical data information that is collected, the thesis discusses the policy rationale around clinical data and regulatory transparency. Then, it describes the clinical data that pharmaceutical sponsors are currently required to disclose by three major health authorities (EMA, HC, and FDA), specifically comparing what information is required to be disclosed in each program, when and how that information is disclosed, and how accessible the information is once disclosed. 

What follows is a qualitative and quantitative comparison of clinical data disclosures of ten recently approved novel drug and biologic products, focusing in particular on the European and Canadian disclosures of clinical information from drug applications. After comparing the information disclosed in over 850,000 pages of documents, the thesis concludes that current programs appear to be functioning, disclosing an unprecedented amount of clinical documents associated with new pharmaceutical marketing and clinical trial applications. The disclosures, however, are often heavily redacted, not for commercial reasons, but to protect patient privacy.

In their current form, the disclosures are difficult to access and navigate and extremely duplicative. The administrative burden of redacting, submitting, and publishing enormous data packages multiple times, in multiple different formats, at multiple health authorities for all new pharmaceutical applications is apparent based on mistakes and inconsistencies between packages. Based on the difficulty in accessing and navigating the documents, it is unclear how useful these disclosures are, or how often – or by whom -they will be used. While the transparency is to be celebrated, the financial and other resource costs of these disclosure programs are high. Without evidence of the need for multiple, duplicative disclosure programs, regulators and legislators ask whether regional disclosure mandates are the best use of limited resources. 

This thesis proposes that regulators and the pharmaceutical industry work together within existing international organizations to develop a harmonized disclosure where final clinical data is available in a single format in a central location with specific access restrictions to allow for data access with fewer redactions.

Pages: 112

Annexes: 8; Pages: 50