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Could data science be about to revolutionize the regulatory approval of new drugs?


The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data. Sophisticated machine learning (ML) and artificial intelligence (AI) techniques allow us to access
and analyze any combination of a multitude of data sources. The way that traditional controlled sources are viewed is being adapted in light of new evidence that emerges from real-world data. A recent Deloitte survey (1) found that 90 percent of biopharma companies are making significant investments in
real-world evidence capabilities to drive drug development and meet regulatory requirements.

Real-world evidence (RWE) has historically been used for post-marketing endorsement and in pricing and reimbursement negotiations. But could data science offer an opportunity to fundamentally shift this
paradigm, leading to better and more affordable medications being approved on the basis of RWE?

In June 2018, Cytel created and ran a survey asking respondents from our audience about the potential of data science approaches in the sector.  We are now excited to share the insights from the survey* ( designed as a qualitative pulse check) which reveal a powerful potential shift in the current drug development and approval paradigm.  


Key Highlights Include:

Less than 1 in 7 of all respondents suggested a definition of data science

Three-quarters of all respondents said their organizations had a dedicated data science department

The majority of respondents agreed that improved clinical trial design is a goal that will benefit most from data science

Skill gaps are cited by the almost half of all respondents as a key barrier to greater use of data science

Almost half the respondents believe the cost of standardizing and cleaning databases to be a challenge for the data science community

Respondents across all functions perceive the key opportunity for data science to be in maximizing the value of real-world data

44% of respondents believed that data science approaches on real-world evidence may in some cases replace controlled experimentation for the regulatory approval of a new drug

Click the button below to download your complimentary copy of the report.


*Many of the responses were obtained from delegates at conferences our team attended in June 2018, and we acknowledge that our pool of respondents at the PSI (Statisticians in the Pharmaceutical Industry) 2018 and PhUSE US Connect 2018 events will likely have interest in certain methods and topics.


1) Getting real with real-world evidence (RWE): Deloitte Insights


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