The pharmaceutical industry continues to share significant volumes of clinical data, contributing to secondary research, supporting transparency and meeting a range of regulatory requirements.

In fact, many companies go beyond their obligations by voluntarily publishing data via secure platforms such as Vivli and Clinical Study Data Request (CSDR), which facilitate carefully controlled access to data by researchers. Moreover, members of EFPIA and the US trade association PhRMA have expressed their commitment to responsibly sharing clinical trial data in The Principles for Responsible Clinical Trial Data Sharing.

Over time, new regulatory requirements, along with data access requests from the scientific community, have grown. As part of our commitment to advancing impactful disclosure, EFPIA engaged Lygature, a partnership management organisation with a special interest in topics such as data sharing, to assess the impact of current disclosure activities. Lygature has produced a report based on a literature review and expert interviews.

The aims of this work were (a) to understand the perceived value for public health of the various mandatory and voluntary disclosure activities, and (b) to develop an approach for the quantification of the use and value of disclosure.

Our instinct to measure outcomes and outputs of data disclosure is in line with the approach that underpins all clinical research: identify a hypothesis – and test it. The hypothesis is that, in return for the effort and risks inherent in publishing data, disclosure delivers benefits to the public health ecosystem.

Data disclosure continues to grow, but is it having the desired impact?

The report provides an overview of the major mandatory and voluntary disclosure types that the pharma industry supports. A more challenging task is measuring the impact of these various activities. In simple terms, the volume of document and data disclosure is high and rising, but is this growing volume of disclosure delivering on the original goals driving disclosure?

On this, the Lygature report reveals gaps in our collective understanding of the broader public health impact of disclosure activities. Some voluntary disclosure websites report metrics that provide indications of added value. However, the authors argue that these are largely output-related and may not fully capture the public health impact. The report suggests that a more comprehensive approach to measurement is warranted.

For mandatory disclosure venues, the researchers found no systematic reporting of indicators that measure the potential impact on public health of the disclosure elements.

EFPIA is committed to data disclosure, but acknowledging that resources are not unlimited, would like to prioritise those activities with funding, urgency and resources where it can provide the greatest overall positive impact. It is vital that all stakeholders work together to develop concrete metrics that can measure the impact on public health of the broad range of disclosure activities.

As requirements for disclosure grow, we should reflect on the true value of the activities we invest resources in and whether they support the fundamental goals of disclosure. It is essential that we prioritise investment in what provides the greatest good.