Academic journal article Houston Journal of International Law

The Data Liberation Movement: Regulation of Clinical Trial Data Sharing in the European Union and the United States

Academic journal article Houston Journal of International Law

The Data Liberation Movement: Regulation of Clinical Trial Data Sharing in the European Union and the United States

Article excerpt

  I. INTRODUCTION  II. BACKGROUND III. RISKS AND BENEFITS OF SHARING NON-SUMMARY         DATA  IV. THE PATH TO NON-SUMMARY DATA SHARING      A. Introduction      B. Transparency Laws      C. EMA Policy on Reactive Non-Summary Data         Sharing      D. The EMA and Proactive Non-Summary Data         Sharing      E. The FDA Policies and Reactive Non-Summary         Data Sharing      F. FDA and Proactive Non-Summary Data Sharing   V. CONCLUSION 

I. INTRODUCTION

There are currently over 200,000 studies registered on clinicaltrials.gov, (1) and 4,000 new studies take place in the European economic area each year. (2) Clinical trials yield thousands of pages of valuable safety and efficacy data. (3) The trial's sponsor submits that data to a regulatory body, like the U.S. Food and Drug Administration (FDA) in the united States or the European Medicines Agency (EMA) in the European Union, to obtain approval to market a drug, biologic, vaccine, or other therapeutic health product to the public. (4) Clinical trial data submitted to support a marketing application could be pooled and re-analyzed to benefit the public, (5) but only if the data are made available for those uses. Historically, pharmaceutical manufacturers were unwilling to share the raw data they generated in clinical trials, and the policies of the United States and the European Union enabled that secrecy.

However, right now, clinical trial data are the subject of an international discussion about government transparency, public health, and scientific innovation that threatens the data exclusivity that the drug industry has typically enjoyed. (6) Industry is under increasing pressure to provide outside scientists access to detailed, patient-level clinical trial data, as well as the protocols followed to collect data and the analytic tools used to interpret its meaning, for the sake of innovation and for the good of public health. (7)

This comment will focus on the role that regulatory bodies in the European Union and United States are playing in making data sharing a compulsory resultant of the marketing approval process. Each has taken action to increase the amount of data available to the public through governmental agencies. (8) The discussion will explore and compare the paths to increased data sharing taken by the European Union, through the EMA, and the United States, through the FDA. It will show that the evolution of the EMA's early reactive data sharing rules into proactive, patient-level data sharing policies was founded on a public health argument that is not available to the FDA.

Part II will follow the evolution of data sharing regimes. Part III will put the data-sharing discussion into the context of its real world implications through an evaluation of some justifications for increased sharing as well as potential risks. Finally, Part IV compares the transparency laws governing release of data in the European Union and the United States to discern their similarities and critical differences. The purpose of this comment is to show that the FDA is constrained by U.S. law in a way that the EMA is unconstrained and to discuss the distribution of risk in the data sharing systems that are emerging in the European Union and the United States.

II. BACKGROUND

Between 1997 and 2008, a global push for greater disclosure of information relating to clinical trials led to policy changes at the World Health Organization (WHO), the World Medical Association (WMA), the EMA, and the FDA and to the creation of three clinical trial registries. As a result of these efforts, the public gained access to basic information about a study. (9)

In the United States, the National Institutes of Health (NIH) established the country's first clinical trial database, clinicaltrials.gov, in February of 2000, under authority granted to it by the U.S. Congress in the Food and Drug Administration Modernization Act (FDAMA). …

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