Last Updated on October 30, 2021 by The Health Master
Indian pharma considers USFDA guidance on real-world data: assessing electronic health records (EHR) and medical claims data will support regulatory decision making for drug and biological products.
The industry sees that this could back regulatory evaluations during clinical research thus speeding up drug development processes.
The guidance according to the global regulatory authority is intended to provide sponsors, researchers, and stakeholders with considerations when proposing to use EHRs or medical claims data in clinical studies which could back a regulatory decision on effectiveness or safety.
It was the 2016 Cures Act, which was intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them.
Among other provisions, the Cures Act indicates which helped USFDA create a framework for a programme to evaluate the potential use of real-world evidence (RWE) to help the approval of a new indication for a drug which is already cleared to satisfy post approval study requirements.
Now the global regulatory is issuing the guidance as part of its RWE Programme which covers clinical studies that use real-world data such as information from routine clinical practice, to derive real-world evidence.
The real world data relating to patient health status or the delivery of health care routinely is gathered from various sources.
Now real world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real world data.
These include data derived from EHRs, medical claims, data from product records and disease registries, patient-generated data including from in-home use, and data gathered from other sources that can inform on health status, such as digital health technologies.
According to USFDA, the current guidance focuses on health-related data recorded by providers that can be extracted from two sources. One is the EHRs and the second is medical claims data.
EHRs and medical claims data contain patient health information, which is widely used in safety studies. In fact it is increasingly being proposed for use in arriving at the effectiveness of studies.
EHR and medical claims data can be considered as data sources in various clinical study designs.
According to a section of clinical researches in Karnataka said that the guidance is of much significance in the current times.
The collation of data from EHR and medical claims provide a direction on the disease condition and the extend of expenses incurred by the patient. Therefore there EHRs and medical claims support regulatory decisions.
USFDA stated that the selection of data sources that appropriately address the study sufficiently characterize study populations and outcomes of the treatment protocols for the diseases.
“Development and validation of definitions for study design elements like for instance the exposure, outcomes and quality during data accrual, provide a specific dataset.
This guidance does not provide recommendations on choice of study design or type of statistical analysis, not does it endorse any type of data source or study methodology.
For all study designs, the global authority said it is important to ensure the reliability and relevance of the data used to help support a regulatory approval.
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