A written description of a study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations and analysis are collated in a single report.
They are challenging two distinct Agency decisions to grant access to non-clinical and clinical information (including clinical study reports) previously submitted by companies as part of their marketing authorisation applications.
While the Commission proposes to make the EU database public unless confidentiality is required to protect personal data and business information, the left-of-centre MEPs find that clinical study reports should not be considered commercially confidential once marketing authorisation has been granted or the authorisation process completed.
The results of the trial will be published in the Annals of the New York Academy of Sciences, and a clinical study report will be forwarded to the US Food and Drug Administration (FDA), the company said.
We commend FDA's efforts to modernize the New Drug Regulatory Program through the use of: (1) The Clinical Data Summary Pilot Program (Pilot), through which parts of a Sponsor's clinical study reports (CSRs) are posted and (2) a new integrated template that will be used to document FDA's review of new drug applications and efficacy supplements.
There is growing interest in assessment of efficacy and harm using company clinical study reports (CSRs) because of limits in the amount of information in articles published in the medical literature [2-4].
Since the funds for many clinical trials are supplied by drug manufacturers, who in turn receive large public subsidies, clinical trial data should be considered a "public good" (13) Yet chug manufacturers continue to assert ownership and proprietary rights to clinical trial data including clinical study reports (CSRs).