Real World Testing Data and FDA Acceptance of Real World Evidence

In the 21^st Century Cures Act, FDA is required to accept Real World Evidence (RWE) in support of market approval decisions. However, the RWE is based off the Real World Data (RWD) which is highly variable and hence could impact the acceptability of RWE derived from such RWD. One of the most sought-after RWD is from patient medical records; it is generally accepted that medical records could provide a real insight into the disease progression and its management across large diverse patient populations. However, disease management data from various sources varies a lot due to variable preferences of the physicians managing a given patient and the organization to which the physician belongs. In a survey of more than 43,000 adults hospitalized at 96 hospitals in Texas for bacterial pneumonia or cellulitis, it was found that patients at teaching hospitals got about 50% more laboratory tests conducted on them compared to those at nonteaching hospitals. The survey was conducted at 23 teaching hospitals and 73 nonteaching hospitals. Although it was conducted in only one state, it is safe to assume that these trends are presented nationwide. There could be additional variation if we include individual practitioners. Variability of patient management across different organizations is not surprising. Rather the survey indicates systematic trends in the variability which should allow addressing it relatively easily. RWE is an important tool for finding health management trends. As we understand and tabulate the intricacies of RWD, the quality of RWE should improve. It is important that subtle non-obvious factors such as the kind of organization contributing the RWD elements be considered when evaluating such data. Additionally standardization of data collected across different organizations to minimize variable elements and contextualization of data element should be considered. FDA is expected to release guidance documents for regulatory requirements for RWE; and it is widely accepted that the above concerns will be included in those documents