Public disclosure of clinical trial information is done in line with the position of the global pharmaceutical industry associations laid down in the . Increased transparency while maintaining patient privacy will ultimately encourage innovation and benefit patients. Researchers can use this site to request access to anonymized patient- level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Eli Lilly and Company Clinical Trial Registry Eli Lilly and Company is committed to meeting patient needs through innovative medicine and clinical. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. Data access will be granted to anonymized patient- level data, protocols and clinical study reports after approval by an independent scientific review panel. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 0. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded. Public disclosure of clinical trial information. Bayer publicly discloses information on its trials by the use of Clinical Trial Registries and Clinical Trial Result Databases. Whereas in Clinical Trial Registries summaries about trial design will usually be disclosed before the trials will start, Clinical Trial Result Databases inform the public about the outcome of trials, independent whether the results are favorable or unfavorable to a Bayer product. Disclosure of clinical trial registry information. Bayer submits information on its clinical trials to the publicly funded website www. Clinical. Trials. Trials sponsored by Bayer of drug development phases II, III, and IV, and trials concerning Bayer’s Medical Devices are registered. Covered are interventional clinical trials related to Bayer’s drug development which started after July 0. Additionally, trials in patients of drug development phase I which started after January 0. Observational studies based on primary data collection evaluating the effects of Bayer drugs and initiated and funded by Bayer are registered on www. Clinical. Trials. May 1, 2. 00. 7. This registration commitment is extended from May 0. Bayer based on secondary data collection focusing on the evaluation of efficacy and safety of Bayer drugs. Clinical Trial Registry information on Bayer trials are also provided in the Bayer Trial Finder application on the Bayer website. Disclosure of clinical trial results information. Trial Result Summaries of Bayer’s sponsored clinical trials in drug development phases II, III and IV are provided in the Bayer Trial Finder application, if such trials have been conducted on Bayer’s drugs approved for marketing and commercially available. Bayer posts results of interventional clinical drug trials in this scope that have been completed after July 0. Additionally, results of phase I trials in patients which started after January 0. Results summaries of observational studies registered by Bayer are provided in the Bayer Trial Finder application. Thank you for your interest in Roche's clinical research. Information about our studies is now provided through independent registries such as ClinicalTrials.gov and EUdraCT. For all other queries please use the webform on the data sharing pages of our corporate website.
The study result information is usually available within 1. The content of the published Trial Result Summaries conforms to the principles required by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Industry: Structure and Content of Clinical Study Reports (ICH E3 Guidance). In addition results of clinical drug trials, and results of trials with Bayer’s Medical Devices cleared for marketing will be provided on the publicly funded website www. Clinical. Trials. FDA Amendment Act. Access to the above mentioned databases including the Bayer Trial Finder is unrestricted and free- of- charge. In order to help inform patients about the clinical trials in which they participate, Bayer will work as member of EFPIA and Ph. RMA with regulators to adopt mechanisms for providing a factual summary of clinical trial results in lay language. All Bayer- sponsored clinical trials are considered for publication in the scientific literature irrespective of whether the results of the clinical trials are positive or negative. At minimum results from all phase III studies should be submitted for publication in scientific journals. Though information on Bayer’s trials may be found in other public databases as well, the above mentioned databases provide the most comprehensive overview on Bayer’s clinical trials. The search engine offered by the WHO (http: //www. Clinical Trial Registries. If you have questions concerning Bayer.
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October 2017
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