GSK to expand clinical trial disclosures
GSK said it will expand publication of research on its Clinical Study Register to include all meta-analyses of multiple clinical trials, observational studies using patient data from real world settings and clinical data from research programs terminated in development. The company will also submit results for publication in peer-reviewed medical journals “wherever possible,” and will “provide context and interpretation of the results” on its Clinical Study Register for those studies not published.
Summary information posted to the GSK Clinical Study Register will now include the names of investigators participating in company-sponsored clinical trials, and for trials starting in 2010, payments to healthcare professionals conducting the trials will also be disclosed.
“Thereafter, this will be extended to payments for other types of research and to healthcare professionals and institutions outside the US,” the company said in a release.
In addition, GSK will begin reporting speaking and consulting fees paid to physicians in Europe as it does for US physicians.
CEO Andrew Witty said in a statement: “Continually strengthening our contract with society is vitally important and this is why we are fully committed to operating to the highest ethical standards."
GSK also announced a 13% increase in charitable contributions, along with plans to lower the price of its drugs in developing countries, reinvest 20% of the profits from sales in those countries to strengthening healthcare infrastructure and to “develop a more flexible approach to intellectual property rights to stimulate research into medicines for neglected tropical diseases.” To that end, GSK will place over 500 granted patents and over 300 pending patents in a pool to help third parties develop drugs for those ailments.