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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.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
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.
Personalized medicine, also referred to as precision medicine, is a medical model that separates people into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease. The terms personalized medicine, precision medicine, stratified medicine and P4 medicine are used interchangeably to describe this concept, though some authors and organizations differentiate between these expressions based on particular nuances. P4 is short for "predictive, preventive, personalized and participatory".
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
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular medical condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.
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.
The philosophy of healthcare is the study of the ethics, processes, and people which constitute the maintenance of health for human beings. For the most part, however, the philosophy of healthcare is best approached as an indelible component of human social structures. That is, the societal institution of healthcare can be seen as a necessary phenomenon of human civilization whereby an individual continually seeks to improve, mend, and alter the overall nature and quality of their life. This perennial concern is especially prominent in modern political liberalism, wherein health has been understood as the foundational good necessary for public life.
Comparative effectiveness research (CER) is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances. Engaging various stakeholders in this process, while difficult, makes research more applicable through providing information that improves patient decision making.
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.
Dan Riskin is an American entrepreneur and surgeon. As an expert in healthcare artificial intelligence, Riskin has promoted healthcare quality improvement and helped shape policy in the US and globally. Riskin's companies, featured in Forbes and The Wall Street Journal, have influenced the care of millions of patients. He continues to practice, teach, and perform research as Clinical Professor of Surgery at Stanford University.
Gender-biased diagnosing is the idea that medical and psychological diagnosis are influenced by the patient's gender. Several studies have found evidence of differential diagnosis for patients with similar ailments but of different sexes. Female patients face discrimination through the denial of treatment or miss-classification of diagnosis as a result of not being taken seriously due to stereotypes and gender bias. According to traditional medical studies, most of these medical studies were done on men thus overlooking many issues that were related to women's health. This topic alone sparked controversy and questions about the medical standard of our time. Popular media has illuminated the issue of gender bias in recent years. Research that was done on diseases that affected women more were less funded than those diseases that affected men and women equally.
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by some consumer organizations.
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 data (RWD) in medicine is data derived from a number of sources that are associated with outcomes in a heterogeneous patient population in real-world settings, including but not limited to electronic health records, health insurance claims and patient surveys. While no universal definition of real world data exists, researchers typically understand RWD as distinct from data sourced from randomized clinical trials.
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The trial was announced 18 March 2020, and as of 6 August 2021, 12,000 patients in 30 countries had been recruited to participate in the trial.
In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis. Adaptive design typically involves advanced statistics to interpret a clinical trial endpoint. This is in contrast to traditional single-arm clinical trials or randomized clinical trials (RCTs) that are static in their protocol and do not modify any parameters until the trial is completed. The adaptation process takes place at certain points in the trial, prescribed in the trial protocol. Importantly, this trial protocol is set before the trial begins with the adaptation schedule and processes specified. Adaptions may include modifications to: dosage, sample size, drug undergoing trial, patient selection criteria and/or "cocktail" mix. The PANDA provides not only a summary of different adaptive designs, but also comprehensive information on adaptive design planning, conduct, analysis and reporting.
References
- ↑ "Real-World Evidence". www.fda.gov. Retrieved 2022-09-19.
- ↑ "Text - H.R.34 - 114th Congress (2015-2016): 21st Century Cures Act | Congress.gov | Library of Congress".
- ↑ Commissioner, Office of the (April 25, 2023). "Real-World Evidence". FDA.
- ↑ Ehsani-Moghaddam B, Martin K, Queenan JA (2021). "Data quality in healthcare: A report of practical experience with the Canadian Primary Care Sentinel Surveillance Network data". Health Information Management Journal. 50 (1–2): 88–92. doi:10.1177/1833358319887743. PMID 31805788. S2CID 208743562.
- ↑ Kahn MG, Callahan TJ, Barnard J, Bauck AE, Brown J, Davidson BN, Estiri H, Goerg C, Holve E, Johnson SG, Liaw ST, Hamilton-Lopez M, Meeker D, Ong TC, Ryan P, Shang N, Weiskopf NG, Weng C, Zozus MN, Schilling L (2016). "A Harmonized Data Quality Assessment Terminology and Framework for the Secondary Use of Electronic Health Record Data". eGEMs. 4 (1): 1244. doi:10.13063/2327-9214.1244. PMC 5051581 . PMID 27713905.
- ↑ 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
- ↑ Berger, Marc L. et al. “Good Practices for Real‐world Data Studies of Treatment And/or Comparative Effectiveness: Recommendations from the Joint ISPOR‐ISPE Special Task Force on Real‐world Evidence in Health Care Decision Making.” Pharmacoepidemiology and Drug Safety 26.9 (2017): 1033–1039. PMC. Web. 5 May 2018.
