The topic of clinical trial data transparency has attracted interest and debate around the globe. While some are wrestling with questions such as the ownership and management of genomic data, here in India, we are still addressing more fundamental questions. Questions continue to be asked as to whether or not data supporting regulatory decisions should be publicly available, and whether physicians are provided the information they need to make informed treatment decisions.
It is standard practice worldwide for pharmaceutical companies to publish the results of global clinical studies in medical publications, at conferences and even on publicly accessible websites. Furthermore, many regulatory authorities publish the data on which approvals were granted as part of a dossier or summary report. In India, there continues to be limitations regarding the clinical information that is made available to physicians and patients, following regulatory approvals.
Roche believes that this needs to change. Information regarding the data available for each product should be included in the label and made publicly available to enable physicians to make informed treatment decisions.
For more information on Roche’s clinical trials, visit