Both electronic health records (EHRs) and patient registries store and use patient-related clinical information. However, they are conceptualized for different purposes. Both are a significant source of real-world evidence (RWE) as they gather a considerable amount of clinical information collected in the real-world setting. An EHR is an electronic record of health data generated during […]
Patient Records Abstraction (PRA) is a process done manually by searching through a medical record to identify data required for a particular or secondary use. It consists of direct matching of information found in the record to the data required, but also includes operations on the data such as categorizing, coding, transforming, interpreting, summarizing, and […]
A recently published study by Dyer O (2017) exposed major drawbacks in the accelerated approval process of some drugs available to the American patients without any stringent clinical evidence of their benefits. (1) Drugs receiving fast track approvals from the US Food and Drug Administration (FDA) often rest on a weak evidence base, says research […]
Bioresorbable stents have effectively been pulled from the European market by Abbott and will now be available only in “clinical registry setting at select sites/institutions” in Europe, where they will be monitored till a review in 2018. India has been among the largest markets for these stents in recent years. The development comes in the […]
Clinical research includes the traditional prospective clinical trials, cohort studies, and case-control studies, while outcomes research (OR) has now solidified itself as a separate class of clinical research. OR is an evolving and critical part of health sciences research due to its focus on the improvement of patient care in the practice setting. Evidence included […]
