GSK supports the AllTrials campaign for transparency in clinical trials.
Madrid, March of 2013- GlaxoSmithKline (GSK) has demonstrated its commitment to transparency in clinical trials, to make public their support to the campaign AllTrials. This campaign calls for the registration of clinical trials and the disclosure of their results and reports of clinical studies (Clinical Study Reports – CSRs), to help promote scientific knowledge.
GSK already made public much information about their clinical studies. The company records and publishes a summary of information about each study that initiates and shares the results of all their studies both if positive as negative, in an open access website. Currently this site includes nearly 5,000 clinical trials results reporting and receives an average of 11,000 visits per month. The company had already previously acquired commitment to try to publish in scientific journals the results of all clinical trials that assess your medications.
Extending what already does, GSK has pledged to make public the reports of clinical studies (CSRs) in its clinical trials registry website. The CSRs are formal reports of studies that provide more details about the design, methodology and results of clinical trials, and constitute the basis of the requests to regulatory agencies. From now on, GSK will publish the CSRs on all your medicines once they have been approved or discontinued development and the results have been published, with the purpose of promoting the results are first reviewed by regulatory authorities and the scientific community. Any personal data of patients will be removed of SRF and its appendices to ensure that patient confidentiality is maintained.
In addition, although there are certain practical difficulties, GSK has intended to publish the CSRs of clinical trials of all drugs that have come to market since the creation of GSK. This will require the recovery and analysis of each historic CSR, to remove the confidential information of the patients. Given the large volume of studies involved, GSK will devote a specialized equipment to perform this work, which is expected to complete within a few years, giving priority to the CSRs of their most common prescription drugs.
Patrick Vallance, President Pharmaceuticals R & D GlaxoSmithKline, said: we promise to be transparent with our clinical trials data to contribute to the advancement of scientific knowledge and information with medical criteria. Our commitment also acknowledges the great contribution made by the people who participate in clinical research. All those involved in the preparation and publication of clinical research, both companies and GSK, such as academic institutions and research organizations, have a role to play to ensure that data that are publicly available for the benefit of the patient ”.
On the other hand, in October 2012, beyond the call made by the campaign of AllTrials, GSK announced that it would develop a system where researchers may apply for access to detailed data of anonymous patients in clinical studies to allow scientific analysis and research furtherin order to contribute to increasing the scientific knowledge.
GlaxoSmithKIine (GSK), one of the companies leading world pharmaceutical research and health care, aims to improve the quality of people’s life, enabling people to have more vitality, feel better and live longer.