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).
Authors
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Keywords
- The quality of research
- Editorial Policies
- Data Collections
- Peer Review / standards
- Data collection
- Epidemiologic Methods
- Medical Records Systems, Computerized
- Reproducibility of Results
- Ethical Analysis
- Real World Data
- Real World Evidence
- RECORD Statement
- Reporting guidelines to pharmacoepidemiological research
- RECORD_PE
- REporting of studies Conducted using Observational Routinely-collected Data
Author Biography
, Universidad del Valle. Cali, Colombia
MD from the Universidad Nacional de Colombia, Master in Pharmacology and PhD in Biomedical Sciences from the Universidad del Valle. Professor at the Universidad del Valle and director of the Centro de Estudios Cerebrales. He is a researcher in the area of experimental pharmacology and pharmacoepidemiology.
He has been a part of Colombia Médica journal editorial committe since 2008 and He is currently the editor of the journal since 2015. As editor, he has implemented the use of bibliometric technology resources and editorial standards that improve the international visibility of the journal.
https://orcid.org/0000-0001-8091-9954References
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