In a JAMA Viewpoint piece, CDER director Janet Woodcock and colleagues reinforced FDA’s stance on the incorporation of real-world evidence into clinical trials, as well as the use of pragmatic studies pre or post-market to collect data on optimal dosing and treatment effects in subpopulations.
In the piece, FDA defines real-world evidence as any data collected as part of routine clinical care, including electronic medical records and administrative claims data as well as data generated from personal electronic or “smart” devices, social media and socioeconomic tools.
The agency also notes that there is no clear dichotomy between real-world and “non-real-world” evidence and that the two exist in a continuum.
Woodcock and her colleagues reiterated what she told BioCentury in its 2016 Back to School essay about the value of studies that are randomized within the healthcare system, which can allow for the collection of data and results that are more generalizable to how the drug candidate will be used in the real world. They also noted that these studies can be cheaper to conduct and can help to address other regulatory questions post-approval, including optimal dosing, long-term outcomes and benefits in various subpopulations.
Per Woodcock, et al., “It is not feasible to answer all of these questions with traditional RCTs. Using RWE to begin to address these questions is preferable to having no evidence whatsoever.”
In the piece, FDA defines real-world evidence as any data collected as part of routine clinical care, including electronic medical records and administrative claims data as well as data generated from personal electronic or “smart” devices, social media and socioeconomic tools.
The agency also notes that there is no clear dichotomy between real-world and “non-real-world” evidence and that the two exist in a continuum.
Woodcock and her colleagues reiterated what she told BioCentury in its 2016 Back to School essay about the value of studies that are randomized within the healthcare system, which can allow for the collection of data and results that are more generalizable to how the drug candidate will be used in the real world. They also noted that these studies can be cheaper to conduct and can help to address other regulatory questions post-approval, including optimal dosing, long-term outcomes and benefits in various subpopulations.
Per Woodcock, et al., “It is not feasible to answer all of these questions with traditional RCTs. Using RWE to begin to address these questions is preferable to having no evidence whatsoever.”
