UK pharmaceutical giant GlaxoSmithKline announced yesterday that it will publish more detailed information from it drug research data, after paying $3bn last year to settle accusations that the company provided misleading clinical research data.
GSK said it is committed to transparency and therefore will publish the results of clinical study reports (CSRs) and clinical trials.
Last October the company agreed to make data from clinical trials available to other researchers, including patient-level results that sit behind trials of approved and failed drugs.
GSK also said it will publish CSRs for all its approved or discontinued medicines so the information can be reviewed by regulators and the scientific community. Patient data will be removed to ensure confidentiality.
CRS are formal study reports that provide more detail on the design, methods and results of clinical trials, and form part of submissions made to regulators such as the United States Food and Drug Administration.
GlaxoSmithKline Pharmaceuticals R&D president Patrick Vallance said in a statement; "We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research.
"All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit."
The company will also publish clinical outcomes trials CSRs for all approved medicines dating back to the formation of GSK.
However, it said this will take some time as it will require the retrieval and examination of each historic CSR to remove confidential patient information.
The company said it will put in place a dedicated team to conduct this work, which it expects to complete over a number of years.
Priority will be given to CSRs for its most commonly prescribed medicines.
