This includes guidance on use of synthetic control arms and novel trial designs as well as methodologies to assess the reliability of RWD from multiple sources and fill gaps in real-world data sets. Looking to data marketplaces can help identify potential partners. How can companies realize greater value from RWE? In some scenarios, pharmaceutical companies are looking to virtualize studies so they can continue with minimal impact. This brought down the approval time to three years, approximately 1.8 years shorter than the median for other drugs in an expedited approval program.12, Expanding label indications: Originally approved to treat female breast cancer in 2015, physicians began off-label prescribing of Pfizer’s Ibrance to male breast cancer patients. © 2020 Syneos Health. There are many examples of using RWE in the R&D setting, but respondents indicate that reaching a state where it can be broadly applied will require overcoming several barriers. While there is strong consensus that there are significant opportunities for RWD and RWE use in R&D, survey data suggests that many organizations are yet to make the most of its potential in this area. The impact of using RWE for these applications can be tremendous (see sidebar, “RWE to streamline drug development and improve productivity”).

RWE also could point to correlations and not causations in outcomes, which could be hard to tease apart. However, a deeper analysis suggests that progress around the use of RWE varies within the industry, especially between companies that have mature RWE capabilities and those that do not. At present companies are using strategic partnerships to gain access to high-quality research-grade RWD, particularly for oncology (see sidebar, “Partnering for research-grade RWD”). Quantzig is a pure-play analytics advisory firm concentrated on We anticipate that citizen data scientists and business users will become larger users of these technology platforms. Claims databases may contain errors or coding that maximizes accuracy for billing but not for medical decision-making. There has been a clear shift to cloud-based platforms that provide tools that not only meet the needs of traditional data scientists but also those of business stakeholders and citizen data scientists. Deloitte has been conducting benchmarking surveys of the pharmaceutical industry since 2017 to track trends in strategic focus, investments, challenges, and opportunities for delivering value with real-world data (RWD) and real-world evidence (RWE). Between January and February 2020, the Deloitte Center for Health Solutions surveyed multiple leaders from 17 pharmaceutical companies on their organizations’ RWE capabilities. Regardless of their level of maturity, most surveyed organizations expect to continue to invest in their RWE capability across a multitude of dimensions.

You need a real-world partner. But the virus is moving faster than we can make them, It may be time to reset expectations on when…, It may be time to reset expectations on when we’ll get a Covid-19 vaccine, The Road Ahead: Charting the coronavirus pandemic over the…, The Road Ahead: Charting the coronavirus pandemic over the next 12 months — and beyond, Listen: Pfizer’s Covid-19 mystery, Ashish Jha on pandemic response,…, Listen: Pfizer’s Covid-19 mystery, Ashish Jha on pandemic response, & STAT turns 5, Lessons for monitoring Covid-19 vaccine safety from the H1N1…, Lessons for monitoring Covid-19 vaccine safety from the H1N1 pandemic, This can be difficult.

The use of real world evidence in pharma companies refers to the View in article, Jacqueline Corrigan-Curay, Framework for FDA’s real-world evidence program, US FDA, March 15, 2019. RWE leaders should enable a culture of experimentation and innovation to figure out new ways of working with RWD.

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