Vice President, Real World Evidence, Commercialisation and Outcomes Services
With advances in technology and data availability, RWE can provide more comprehensive data sets for regulators and payers.
Randomised Clinical Trials (RCT) are limited in that they do not address real-life utilisation and real-world performance for new drugs. With the availability of real world evidence (RWE) to do just that, stakeholders’ traditional requirements for evidence are evolving. RWE can estimate the effectiveness of a therapy in actual clinical practice, reflecting a larger population and longer-term outcomes.
Devising a comprehensive RWE strategy can ensure that smart decisions are made in how to best choose, synthesise and analyse available real world data (RWD) assets. By identifying what evidence will support regulators’ and payers’ decision making alike, sponsors can develop an evidence generation plan across the product life cycle to leverage outputs and identify data gaps.
In general, there is a growing realisation among regulators that RCTs need to be supplemented with RWE, and in both the US and EU markets, RWE is at the forefront of regulatory discussions. In the EU, RWE is in routine use, especially for safety monitoring and drug utilisation studies of marketed products, and in the US, RWE is considered a useful tool for routinely monitoring the safety of marketed products and is seen as a way to fill important evidentiary gaps that are not typically addressed with traditional RCTs.
As clearer direction from stakeholders is released, confirmed and put into practice, there is major potential in the implementation of RWE generation strategies. While clinical trials will remain the most important source of knowledge for products in the early development stages, the impact of RWE and RWD on clinical trials and commercialisation will continue to grow.
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This blog is an edited version of “Real world evidence: The evolving views of regulators and payers” which appeared in Pharmafocus in March, 2018. To view the full article, please visit http://edition.pagesuite-professional.co.uk/