Novartis extends leadership in clinical trial data transparency, reinforcing its support of clinical research and innovation
Novartis announces that researchers can now request access to patient level data on newly approved innovative medicines in the United States and EU in 2014 through the ideaPoint portal, and is committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language and additional interpretation of data as of the end of 2014
Novartis has voluntarily disclosed publicly summaries of Clinical Study Reports (CSR) of its innovative medicines on its website (http://www.novctrd.com) and was the first pharma company to publish summaries within one year of the study completion
Novartis to continue its industry leading practice of publishing detailed summary reports of clinical trial results of innovative medicines, both positive and negative, including trial design and key efficacy and safety data
Basel, February 26, 2014 - Novartis announced today additional steps to extend its leadership in clinical trial data transparency. Since 2005, and before requirements were in place, Novartis has been voluntarily disclosing summaries of Clinical Study Reports of its innovative medicines on its own website (http://www.novctrd.com). In addition, the company is committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language summaries and additional interpretation of data as of the end of 2014.
Novartis has long supported data transparency and was the first company to publish positive and negative study results of its innovative medicines within one year of the study completion further enabling clinical research while protecting patient privacy.
To date, Novartis has registered 2,720 trials on ClinicalTrials.gov and published 559 trial results on the same site as well as 1,777 clinical study summaries (known as "redacted clinical study reports"). Researchers can also now request access to patient level data on newly approved innovative medicines in 2014 through the same ideaPoint portal as other pharmaceutical companies.
"Novartis has taken action to extend our leadership regarding clinical data transparency and access to data by researchers. This is designed to further advance science and innovation which can benefit patients," stated Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "We also believe that patient rights and privacy remains paramount, and recognize that such data should not be released without the express consent of the patient".
Novartis is consistently rated as having one of the industry's most respected development pipelines, with over 200 projects in clinical development, including 144 in the Pharmaceuticals Division. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for potentially best-in-class or first-in-class medicines that could significantly advance treatment standards for patients worldwide. The company is committed to science-based innovation that makes a meaningful and measurable difference to patients' lives by delivering the right medicine to the right patient at the right time. The company's unique approach to drug development coupled with its vigorous investment in R&D has yielded important results for patients. In 2013 alone, the company received thirteen major approvals from regulatory authorities and obtained three breakthrough therapy designations for investigative medicines from the U.S. Food and Drug Administration - among the highest number for any company.
Disclaimer This press release contains expressed or implied forward-looking statements, including statements that can be identified by terminology such as "leadership," "support," "can," "committed," "to include," "as of," "to continue," "to extend," "designed," "believe," "should," "potentially," "could," or similar expressions. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results expressed or implied by such statements. These expectations could be affected by, among other things, risks and factors referred to in the Risk Factors section of Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update it in the future.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 136,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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