Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. ... [It] means integrating individual clinical expertise with the best available external clinical evidence from systematic research." The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients.
Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.
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.
Chelation therapy is a medical procedure that involves the administration of chelating agents to remove heavy metals from the body. Chelation therapy has a long history of use in clinical toxicology and remains in use for some very specific medical treatments, although it is administered under very careful medical supervision due to various inherent risks, including the mobilization of mercury and other metals through the brain and other parts of the body by the use of weak chelating agents that unbind with metals before elimination, exacerbating existing damage. To avoid mobilization, some practitioners of chelation use strong chelators, such as selenium, taken at low doses over a long period of time.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in pharmacological contexts, or when the negative effect is expected or common. If the negative effect results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not an adverse effect. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. Adverse effects of medical treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally.
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms.
Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.
Diana M. Zuckerman is an American health policy analyst who focuses on the implications of policies for public health and patients' health. She specializes in national health policy, particularly in women's health and the safety and effectiveness of medical products. She is the President of the National Center for Health Research and the Cancer Prevention and Treatment Fund.
Abiomed, Inc. is a medical device technology company that operates as a stand-alone business within Johnson & Johnson's MedTech Segment. Abiomed develops and manufactures temporary external and implantable mechanical circulatory support devices. The company is headquartered in Danvers, Massachusetts with additional offices in Woburn, Baltimore, Berlin, Aachen, and Tokyo.
David Lawrence Sackett was an American-Canadian physician and a pioneer in evidence-based medicine. He is known as one of the fathers of Evidence-Based Medicine. He founded the first department of clinical epidemiology in Canada at McMaster University, and the Oxford Centre for Evidence-Based Medicine. He is well known for his textbooks Clinical Epidemiology and Evidence-Based Medicine.
The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens.
Steven E. Nissen is an American cardiologist, researcher and patient advocate. He was chairman of cardiovascular medicine at the Cleveland Clinic, in Cleveland, Ohio.
Alternating electric field therapy, sometimes called tumor treating fields (TTFields), is a type of electromagnetic field therapy using low-intensity, intermediate frequency electrical fields to treat cancer. TTFields disrupt cell division by disrupting dipole alignment and inducing dielectrophoresis of critical molecules and organelles during mitosis. These anti-mitotic effects lead to cell death, slowing cancer growth. A TTField-treatment device manufactured by the Israeli company Novocure is approved in the United States and Europe for the treatment of newly diagnosed and recurrent glioblastoma, malignant pleural mesothelioma (MPM), and is undergoing clinical trials for several other tumor types. Despite earning regulatory approval, the efficacy of this technology remains controversial among medical experts.
A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects. A successful pivotal trial is required as evidence for drug marketing approval by the relevant approval authorities, such as the European Medicines Agency, Health Canada or United States Food and Drug Administration (FDA).
Implant failure refers to the failure of any medical implant to meet the claims of its manufacturer or the health care provider involved in its installation. Implant failure can have any number of causes. The rates of failure vary for different implants.
Marie Diener-West is the Helen Abbey and Margaret Merrell Professor of Biostatistics and the chair of the Master of Public Health Program at Johns Hopkins Bloomberg School of Public Health. Diener-West is an editor for the Cochrane Eyes and Vision Group and a member of the American Public Health Association, American Statistical Association, Association for Research in Vision and Ophthalmology, and the Society for Clinical Studies.
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review.
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
Medical reversal refers to when a newer and methodologically superior clinical trial produces results that contradict existing clinical practice and the older trials on which it is based. This leads to an intervention that was widely used falling out of favor, because new evidence either demonstrates that it is ineffective or that its harms exceed its benefits. It is distinct from replacement, which occurs when a newly developed medical treatment supersedes an older, less effective one as the standard of care. Medical reversals are caused when a treatment is widely adopted even when there is not compelling evidence for its safety and effectiveness. For example, an intervention may be adopted because it "makes sense", or because there are observational studies supporting its putative benefits. The negative effects of such reversals include harm to patients who received the intervention when it was considered relatively safe and effective, as well as reducing public trust in medicine.
