December 2021: An IQWiG Update: Call for a Central Portal for Clinical Study Reports

An update about a journal article, Call for a Central Portal for Clinical Study Reports (CSRs) was posted, on the Institute for Quality and Efficiency in Health Care (IQWiG) website on December 01, 2021.

The IQWiG is a professionally independent scientific institute under the Federal Joint Committee (G-BA) or the Federal Ministry of Health (BMG), Germany. Two authors from IQWiG have published an open-access article in the Journal of European CME. This article discusses the need for a central, public, and worldwide portal for accessing CSRs of all the clinical studies carried out worldwide.  The authors also suggest the use of the CSRs not only for dossier assessments but also for developing other information formats such as clinical practice guidelines, continuing medical education (CME) materials, and patient information.

The article acknowledges that the quality of clinical practice guidelines has improved in the form of prospective study registration as a precondition for publication in scientific journals in 2004 and mandatory registration of studies and summaries of study results. Even then, the information related to any intervention, is scattered in different information sources. These sources could be journal publications, public and industry study registries, as well as regulatory and health technology assessment (HTA) agency websites, which results in extensive resources required for retrieving and screening of this information.

As a way of providing a solution to these problems of scattered information sources and the possible influence of the industry on certain scientific materials like the CME, the article suggest establishment of a digitised clinical study portal containing all CSRs which would enable the resource-efficient production of unbiased evidence synthesis, not only to inform health policy decisions, but also for use in other information formats described above, and thus ultimately improve treatment outcomes. The article also provides the basic structure of the portal for each clinical study, including a unique identifier as well as the corresponding CSR (provided proactively) and anonymized IPD (provided on request).

Since experience has shown that voluntary commitments by industry in disclosing trial information are insufficient, the legislators are called upon to establish such a central portal and to make the submission of CSRs mandatory.

For more details of this article can be found here.