Related Research Articles
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
Health informatics is the study and implementation of computer structures and algorithms to improve communication, understanding, and management of medical information. It can be viewed as a branch of engineering and applied science.
An electronic health record (EHR) is the systematized collection of patient and population electronically stored health information in a digital format. These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.
A clinical decision support system (CDSS) is a health information technology that provides clinicians, staff, patients, and other individuals with knowledge and person-specific information to help health and health care. CDSS encompasses a variety of tools to enhance decision-making in the clinical workflow. These tools include computerized alerts and reminders to care providers and patients, clinical guidelines, condition-specific order sets, focused patient data reports and summaries, documentation templates, diagnostic support, and contextually relevant reference information, among other tools. CDSSs constitute a major topic in artificial intelligence in medicine.
In international trade, market access refers to a company's ability to enter a foreign market by selling its goods and services in another country. Market access is not the same as free trade, because market access is normally subject to conditions or requirements, whereas under ideal free trade conditions goods and services can circulate across borders without any barriers to trade. Expanding market access is therefore often a more achievable goal of trade negotiations than achieving free trade.
A patient safety organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors. Common functions of patient safety organizations are data collection, analysis, reporting, education, funding, and advocacy. A PSO differs from a Federally designed Patient Safety Organization (PSO), which provides health care providers in the U.S. privilege and confidentiality protections for efforts to improve patient safety and the quality of patient care delivery
The Clinical Practice Research Datalink (CPRD) is an observational and interventional research service that operates as part of the Department of Health and Social Care. It is jointly funded by the National Institute for Health and Care Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA). CPRD is working closely with the extensive primary care, topic specific and comprehensive NIHR research networks and with NHS Digital.
The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
Disease or patient registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure, and they play an important role in post marketing surveillance of pharmaceuticals. Registries are different from indexes in that they contain more extensive data.
A glossary of terms used in clinical research.
The following outline is provided as an overview of and topical guide to clinical research:
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and holds registrations from over 444,000 trials from 221 countries.
Patient participation is a trend that arose in answer to medical paternalism. Informed consent is a process where patients make decisions informed by the advice of medical professionals.
IDEAL is a framework for describing the stages of innovation in surgery and other interventional procedures. The purpose of IDEAL is to improve the quality of research in surgery by emphasizing appropriate methods, transparency of data and rigorous reporting of outcomes.
Genomic and medical data refers to an area within genetics that concerns the recording, sequencing and analysis of an organism's genome.
Artificial intelligence in healthcare is the application of artificial intelligence (AI) to copy or exceed human cognition in the analysis, presentation, and understanding of complex medical and healthcare data. It can augment and exceed human capabilities by providing better ways to diagnose, treat, or prevent disease. Using AI in healthcare has the potential to improve predicting, diagnosing, and treating diseases. Through machine learning algorithms and deep learning, AI can analyze large sets of clinical data and electronic health records, and can help to diagnose diseases more quickly and accurately. In addition, AI is becoming more relevant in bringing culturally competent healthcare practices to the industry.
Health data is any data "related to health conditions, reproductive outcomes, causes of death, and quality of life" for an individual or population. Health data includes clinical metrics along with environmental, socioeconomic, and behavioral information pertinent to health and wellness. A plurality of health data are collected and used when individuals interact with health care systems. This data, collected by health care providers, typically includes a record of services received, conditions of those services, and clinical outcomes or information concerning those services. Historically, most health data has been sourced from this framework. The advent of eHealth and advances in health information technology, however, have expanded the collection and use of health data—but have also engendered new security, privacy, and ethical concerns. The increasing collection and use of health data by patients is a major component of digital health.
ISPOR—The Professional Society for Health Economics and Outcomes Research, also known as ISPOR is a global, nonprofit 501(c)(3) public organization for educational and scientific purposes, as defined by the United States Internal Revenue Service.
Real-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and retrospective or prospective observational studies. In the USA the 21st Century Cures Act required the FDA to expand the role of real world evidence.
Learning health systems (LHS) are health and healthcare systems in which knowledge generation processes are embedded in daily practice to improve individual and population health. At its most fundamental level, a learning health system applies a conceptual approach wherein science, informatics, incentives, and culture are aligned to support continuous improvement, innovation, and equity, and seamlessly embed knowledge and best practices into care delivery
References
- ↑ Cowley, Andrea. "What is real world data?". CRC Australia. Clinical Research Corporation. Retrieved 8 May 2018.
- ↑ Bian, Jiang; Lyu, Tianchen; Loiacono, Alexander; Viramontes, Tonatiuh Mendoza; Lipori, Gloria; Guo, Yi; Wu, Yonghui; Prosperi, Mattia; George, Thomas J; Harle, Christopher A; Shenkman, Elizabeth A (2020-12-09). "Assessing the practice of data quality evaluation in a national clinical data research network through a systematic scoping review in the era of real-world data". Journal of the American Medical Informatics Association. 27 (12): 1999–2010. doi:10.1093/jamia/ocaa245. ISSN 1527-974X. PMC 7727392 . PMID 33166397.
- ↑ "TriNetX and Takeda Enter Into Agreement to Drive Access to Real-World Data and Analytics". TriNetX. 2021-04-26. Retrieved 2022-02-04.
- 1 2 "Framework for FDA's Real-World Evidence Program". FDA.
- ↑ Yendewa, George A.; Perez, Jamie Abraham; Schlick, Kayla; Tribout, Heather; McComsey, Grace A. (2021-07-01). "Clinical Features and Outcomes of Coronavirus Disease 2019 Among People Who Have Human Immunodeficiency Virus in the United States: A Multi-center Study From a Large Global Health Research Network (TriNetX)". Open Forum Infectious Diseases. 8 (7): ofab272. doi:10.1093/ofid/ofab272. PMC 8244788 . PMID 34435074 – via Oxford Academic.
- ↑ "Use of patient disease registries for regulatory purposes – methodological and operational considerations".
- ↑ "Overview | NICE real-world evidence framework | Guidance | NICE". www.nice.org.uk. 23 June 2022. Retrieved 2022-09-06.
- ↑ https://health.ec.europa.eu/document/download/a7df24c3-d4a3-4218-a8e0-726febfa01c2_en?filename=mdcg_2022-21_en.pdf
Sources
- Real-World Evidence—What Is It and What Can It Tell Us? The New England Journal of Medicine, Dec. 6, 2016
- Mahajan, Rajiv. “Real World Data: Additional Source for Making Clinical Decisions.” International Journal of Applied and Basic Medical Research 5.2 (2015): 82. PMC. Web. 5 May 2018.
