The quality of research with real-world evidence

Abstract

Most of the medical practice has not been proven by controlled clinical trials, and there are no plans to conduct such trials in order to decrease clinician uncertainty. This happens partly due to the difficulty of making designs with scientific and ethical validity, the costs of this type of research and the time required to generate results, which can be several years. Clinical trials do not have the capability to generate information that allows to make decisions in some sectors of clinical care and public health, such as when an epidemic occurs. Therefore, medical science is based on observational studies, past practices and therapeutic tradition (1). Observation of clinical data that have defined a clinical behavior precedes the clinical trial. The knowledge about scurvy, the fact that this pathology is considered a nutritional deficiency and its treatment with citrus fruits, originated thanks to the collection of clinical data on sailors, soldiers and prisoners of the British Crown in the 18th and 19th centuries (2). This clinical information, which was collected uniformly and served to produce new knowledge, is what is now known as Real World Data (RWD). A modern definition of RWD would be one that talks about data obtained by any non-interventionist methodology that is collected prospectively and retrospectively from observations of routine clinical practice, and which comes from various sources including data from patients, doctors, hospitals, payers, social data, etc (3).

Re: Systematic review and meta‐analysis of narrow band imaging for non‐muscle‐invasive bladder cancer

“…We thank Dr G omez-Ospina and Dr Garc ıa-Perdomo for the interesting points raised in their letter to the editor regarding our recent systematic review. 1,2 The main point highlighted was the potential for the methodological selections made within our review to influence decision-making. They cite prior systematic reviews that report more definitive findings than our own, but use a wider range of evidence, including observational studies.…”

“…Those previous studies represent real-world data (RWD) as they correspond to clinical information that produced new knowledge. 2 In this setting, where RCTs are scarce or difficult to reproduce, the inclusion of observational studies could provide greater applicability to clinical practice instead of leading to decisions based on results from a limited number of studies or patients.In addition to the comment above, we would like to point out four further considerations concerning the information sources and search strategy used. First, no information was provided about the review protocol or the existence of a registration number.…”

“…Those previous studies represent real-world data (RWD) as they correspond to clinical information that produced new knowledge. 2 In this setting, where RCTs are scarce or difficult to reproduce, the inclusion of observational studies could provide greater applicability to clinical practice instead of leading to decisions based on results from a limited number of studies or patients.…”

Predicting Lapatinib Dose Regimen Using Machine Learning and Deep Learning Techniques Based on a Real-World Study

“…Real-world study is a process of data mining, model building, and clinical feature data extraction. The main advantages of real-world studies include rich evidence resources, good external validity, individualized program application, and being closer to clinical practice (12,13).…”