Clinical studies: Broad definition of 'commercially confidential' endangers transparency

February 25, 2015

In April 2014 the EU Parliament and Council commissioned the European Medicines Agency (EMA) to establish a publicly accessible database containing comprehensive data from clinical studies. The deadline for comments on the transparency aspect of the database specifications was the 18th of February.

The German Institute for Quality and Efficiency in Health Care (IQWiG), which has long been accompanying EMA on its path to more transparency, also submitted comments. These comments have now been published on the IQWiG website.

Study data are not commercially confidential

In 2014 the EU Parliament made clear that clinical study data generally should not be considered commercially confidential and cannot readily be exempt from publication in the EU study database. Exceptions must be well justified, and redactions or even the non-publication of whole documents must not interfere with overriding public interests, such as the health of patients. The precondition for a database fulfilling these requirements is a precise and narrow definition of "commercially confidential information". IQWiG researchers have reviewed the comprehensive EMA proposal and found a very broad definition in several sections of the document.

Beate Wieseler, Head of IQWiG's Drug Assessment Department, explains: "The decision on which data remain confidential is thus more or less left up to the study sponsors. This contradicts the spirit of the EU regulation and the aim of achieving transparency in clinical research. In addition, the non-publication or long delays in the publication of study results and methods would not be compatible with the ethical principles of studies in human beings, as, for example, stipulated in the Declaration of Helsinki."

Interests of patients override interests of specific groups

IQWiG's point of view is that neither the results nor the methods of clinical studies are commercially confidential information. Interests of specific groups must be subordinate to the public interest in the swift and complete publication of study data and documents. This public interest especially refers to the desire of patients for a thorough assessment of their treatment options.

Some sections of the EMA proposal do not do justice to this change in paradigm outlined in the new EU regulation. EMA has even left a loophole for publicly funded studies: If, for example, the publication of study data could affect the acquisition of further third-party funds, the study sponsors would be allowed to redact information. The planned publication of a study in a scientific journal would also suffice to withhold data. "Especially this example illustrates the imbalance of EMA's proposal", says Wieseler. "In our opinion, a research group's wish to publish an article that might not even be freely accessible must give way to the public interest."

Her conclusion: "The non-publication of certain information must be the absolute exception. Those wishing to redact documents must in each case provide a precise justification to EMA, and EMA must meticulously evaluate these justifications."
-end-


Institute for Quality and Efficiency in Health Care

Related Broad Definition Articles from Brightsurf:

Group of international scientists align on a definition for 'synbiotic'
To address the scientific ambiguity around synbiotics, a group of 11 leading international scientists formed a panel to create a consensus definition and to clarify the evidence required to show synbiotics are safe and effective.

UK 'close contact' definition for track and trace should curb COVID-19 spread but at a cost
The UK's definition of a 'close contact'--15 or more minutes within 2 metres of distance--used for its coronavirus track and trace system, should curb the spread of COVID-19 infection, indicates research published online in the Journal of Epidemiology & Community Health.

Broad spectrum
Digital cameras as well as many other electronic devices need light-sensitive sensors.

MAFLD: A new name and definition brings hope for patients with fatty liver disease
An international consensus panel led by researchers from The Westmead Institute for Medical Research (WIMR) has highlighted the need to redefine Non-Alcoholic Fatty Liver Disease (NAFLD), and to name it Metabolic Associated Fatty Liver Disease (MAFLD).

A broad look at plant-environment interactions
Three plant science journals---the American Journal of Botany (AJB), Applications in Plant Sciences (APPS), and the International Journal of Plant Sciences (IJPS)---have joined efforts to provide a broad look at how plants interact with their environment.

Researchers obtain 'high-definition' view of diabetes-related proteins
Scientists have examined a key receptor for the first time at high resolution -- broadening understanding of how it might function, and opening the door to future improvements in treating conditions such as type 2 diabetes.

Hikikomori: New definition helps identify, treat extreme social isolation
Experts in the Japanese phenomena of hikikomori say the condition of extreme social isolation is more widespread than previously acknowledged, and it deserves a clear and consistent definition to improve treatment across the globe.

To help protect research, experts agree on a definition of predatory publishing
Leading scholars and publishers from The Ottawa Hospital's Centre for Journalology, the University of Ottawa's Telfer School of Management, and other institutions from around the world have agreed on a consensus definition of predatory publishing.

Study offers data-driven definition of unhealthy yet pervasive 'hyper-palatable' foods
New research published in Obesity and presented at the 7th Annual Obesity Journal Symposium offers specific metrics that might qualify foods as hyper-palatable -- and finds most foods consumed in the United States meet these criteria.

Seasons change: Researchers provide new definition for major Indian monsoon season
FSU Professor of Meteorology Vasu Misra has used detailed surface temperature analyses to develop the first-ever objective definition of the Northeast Indian Monsoon.

Read More: Broad Definition News and Broad Definition Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.