Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
During the 12th Annual Conference for the Business of Biotech, held at the Moffitt Cancer Center in Tampa, Florida on March 2, 2018, it was no surprise that the theme of the conference was Discovering Tomorrow’s Cancer Cures. With the keynote on Immunotherapy and the impact it’s having on the treatment of cancer, as well as discussions on Adaptive Therapies, and breakthroughs made possible by the 21st Century Cures Act, one could feel the promise of recent and near-future advancements in the fight against cancer.
With all the science-based presentations at the conference, the session titled Real World Data: Mining Gold from a Mountain of Straw drew my attention. The session focused on Real World Data (RWD) and Real World Evidence (RWE), and how to draw insights from both to improve patient outcomes.
Defining RWD and RWE
Real World Data (RWD) is defined as data derived from a number of sources that are associated with outcomes in patient populations in real-world settings. Real World Data sources include, but are not limited to, the following:
- Electronic Health Records (EHR)
- Administrative and healthcare claims databases
- Social Media, which is playing a bigger role
Real World Evidence (RWE) is still being defined, however, in its simplest form, it is ‘results’ — evidence regarding the usage and potential benefits and risks of a medical product derived from analysis of real world data (data outside of clinical trials which are very controlled).
The insights derived from RWD and RWE are playing a key role in getting the right treatment to the right patient. It is commonly known that what works for one patient does not always work for another. Treatment results outside of a clinical trial often vary from the results experienced in the real world, where patient characteristics do not match exactly those from the clinical trial.
Putting RWD and RWE to Work
Additional uses for RWD and RWE include but are not limited to:
- Improve personalization of medical care
- Development of trial designs
- Monitoring of post-market safety and adverse events
- 21st Century Cures Act places additional focus on the use of RWD and RWE to support regulatory decision making
- Discover new indications for existing treatments
- Coverage (payment) decisions
Maximizing the Potential of RWD and RWE
With all the benefits and uses of RWD and RWE, there is still work to be done in this arena. It takes a lot of data to draw accurate results. In fact, terabytes of data are required, according to one of the panelists for this conference session. The achievement of accurate results also requires a common language, harmonization, and codified and structured data – topics that are not unfamiliar to the Quality Management world.
Real World Data comes from many different sources, as indicated above, and often that data is unstructured. As an industry, we need to figure out how to tap into that unstructured data. Technologies such as Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing, and Block Chain will play key roles in the advancement of RWD and RWE; preparing it for broader use, even public consumption, without compromising patient privacy.
Holding Promise for the Future of Medical Care
Significant strides are being made in the achievement of better health outcomes with the use of RWD and RWE. It is already demonstrating its ability to improve trial designs, and aid in post-market surveillance, support regulatory decisions, and discovering new indications. Ultimately RWE needs to become regulatory-grade to fulfill the promise of providing the right treatment to the right patient. With the combined power of science and technology, the promise is on the horizon.
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