Patient-centric data — Real-World Evidence (RWE) and Real-World Data (RWD) — are becoming increasingly instrumental in the drug development process and for making health care decisions. This type of data not only informs the process of discovery of new indications, but drug development and clinical trials design. It can also be of value to monitor post-marketing drug safety and enable decision support in clinical practice. It is not surprising that science companies and medical organizations are increasingly focused on leveraging RWD and RWE data to better understand patient population use of drugs and the respective outcomes (e.g. responders vs. non-responders), and to accelerate and provide justification for clinical decision support.
New technologies gather and store huge amounts of health-related data
RWD can come from a number of sources, for example:
- Electronic health records (EHRs)
- Claims and billing activities
- Product and disease registries
- Patient-generated data including in home-use settings and patient reported outcomes surveys
- Data gathered from other sources, et. wearables data collected via mobile devices, that can inform on health status
RWE is becoming actionable when powered by analytics, machine learning & artificial intelligence (AI)
RWE provides insight beyond traditional clinical trial data, adding the potential to link data from different sources. This is expected to translate into improved trial efficiency, identification of potential new indications, and generation of a real-world perspective on risks/benefits to make informed decisions beyond traditional clinical trials. RWE is impacting the health care market and has also been getting attention on the regulatory side. AI and information exchange needs to be kept secure in the context of managing, accessing, and extracting insights from RWE.
RWD sets are a critical component in creating a learning system that allows us to modify and improve treatment strategies based on RWE.
Chris Cournoyer, former CEO of N-of-One, now strategic advisor to QIAGEN and Chair to PMWC 2020’s Track 4: ‘Molecular Profiling – From Research to Clinic’
PMWC Jan. 21-24, 2020 Silicon Valley has several exciting sessions scheduled that focus on clinical RWE data, the FDA’s perspective on RWD and RWE, as well as other relevant aspects the regulators are actively involved in and that empower the advancement of precision medicine.
See what other timely and critical topics PMWC 2020 Silicon Valley program has to offer and how you can take advantage of early registration to secure your place at this unique scientific gathering focused on precision medicine.
