The major trade group for the global pharmaceutical industry, Pharmaceutical Research and Manufacturers of America (PhRMA), and economic consulting firm Analysis Group, Inc. (AG) have selected benchmark industry tools from Medidata Solutions (NASDAQ: MDSO) as the key input for research into the costs of post-approval clinical trials.
Clinical trials are one of the costliest areas in bringing safe and effective new treatments to patients. After a medicine has been approved for initial use, pharmaceutical companies often invest further in determining its effectiveness and safety for new populations, such as pediatric patients. PhRMA and AG are analyzing the costs associated with these post-approval trials, identifying cost drivers and variations.
The research will rely on the world’s largest databases of negotiated clinical costs from Medidata Grants Manager ® and Medidata CRO Contractor ®, which have the PICAS ® and CROCAS ® databases containing hundreds of thousands of data points from actual executed protocols, investigator grants and other contracts from pharmaceutical and other research sponsors.
- “Research on a new medicine often continues long after marketing approval, generating crucial information on a medicine's safety in a broader population and potential efficacy for new indications. Efficiently and effectively conducting these clinical trials is key to industry’s ability to provide new and improved treatment options to patients,” said Lori Reilly, vice president of policy and research, PhRMA. “Medidata’s benchmark cost database solutions are ideal for helping us understand factors affecting post-approval research.”
Working with AG, a widely-recognized group of health economics experts, PhRMA will deliver the key data points that will form the foundation of this research.
- “We will be examining how cost factors vary across indications and uses, allowing us to build on past research,” said Genia Long, managing principal, Analysis Group. “Medidata's detailed clinical trial data allows for thorough investigation of drivers of clinical trial costs.”
- “Our data-based trial planning solutions are widely used by drug companies to rein in trial costs through efficient planning, negotiation and management,” said Glen de Vries, president, Medidata Solutions. “We are very pleased that these tools are also underpinning some of the most important research in pharmaceutical economics, helping develop new industry strategies to streamline the research process.”
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