
Published
22 September 2011 | By Kinapse
The traditional drug development paradigm must change. We propose a fundamentally new approach which will create a win-win partnership between industry, academia, health authorities, health technology assessment (HTA)/health economic program (HEP) bodies and patients. We call this new approach “Real World Development” the underlying principle of which is to constantly assess the product in as close to post-marketing use as possible. Key components of this approach are the use of adaptive trial design and capitalisation of existing real world data sources. It enhances the evaluation of benefit/risk, enable earlier patient access to innovative medicines, and improve value for money.
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