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Vaccine Efficacy
Vaccine efficacy or vaccine effectiveness is the percentage reduction of disease cases in a vaccinated group of people compared to an unvaccinated group. For example, a vaccine efficacy or effectiveness of 80% indicates an 80% decrease in the number of disease cases among a group of vaccinated people compared to a group in which nobody was vaccinated. When a study is carried out using the most favorable, ideal or perfectly controlled conditions, such as those in a clinical trial, the term ''vaccine efficacy'' is used. On the other hand, when a study is carried out to show how well a vaccine works when they are used in a bigger, typical population under less-than-perfectly controlled conditions, the term ''vaccine effectiveness'' is used. Vaccine efficacy was designed and calculated by Greenwood and Yule in 1915 for the cholera and typhoid vaccines. It is best measured using double-blind, randomized, clinical controlled trials, such that it is studied under "best case scenario ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Fluzone
Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. The United States Centers for Disease Control and Prevention (CDC) estimates that vaccination against influenza reduces sickness, medical visits, hospitalizations, and deaths. Immunized workers who do catch the flu return to work half a day sooner on average. Vaccine effectiveness in those over 65 years old remains uncertain due to a lack of high-quality research. Vaccinating children may protect those around them. Vaccines are an effective means to control outbreaks of many diseases. However, vaccines for respiratory viral infections such as flu are still suboptimal and do not offer broad-spectrum protection. Vaccination against influenza began in the 1930s, with ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Outcome Data
Qualitative research is a type of research that aims to gather and analyse non-numerical (descriptive) data in order to gain an understanding of individuals' social reality, including understanding their attitudes, beliefs, and motivation. This type of research typically involves in-depth interviews, focus groups, or observations in order to collect data that is rich in detail and context. Qualitative research is often used to explore complex phenomena or to gain insight into people's experiences and perspectives on a particular topic. It is particularly useful when researchers want to understand the meaning that people attach to their experiences or when they want to uncover the underlying reasons for people's behavior. Qualitative methods include ethnography, grounded theory, discourse analysis, and interpretative phenomenological analysis. Qualitative research methods have been used in sociology, anthropology, political science, psychology, social work, folklore, educational ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Absolute Risk Reduction
The risk difference (RD), excess risk, or attributable risk is the difference between the risk of an outcome in the exposed group and the unexposed group. It is computed as I_e - I_u, where I_eis the incidence in the exposed group, and I_u is the incidence in the unexposed group. If the risk of an outcome is increased by the exposure, the term absolute risk increase (ARI) is used, and computed as I_e - I_u. Equivalently, if the risk of an outcome is decreased by the exposure, the term absolute risk reduction (ARR) is used, and computed as I_u - I_e. The inverse of the absolute risk reduction is the number needed to treat, and the inverse of the absolute risk increase is the number needed to harm. Usage in reporting It is recommended to use absolute measurements, such as risk difference, alongside the relative measurements, when presenting the results of randomized controlled trials. Their utility can be illustrated by the following example of a hypothetical drug which reduces the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Relative Risk Reduction
In epidemiology, the relative risk reduction (RRR) or efficacy is the relative decrease in the risk of an adverse event in the exposed group compared to an unexposed group. It is computed as (I_u - I_e) / I_u, where I_e is the incidence in the exposed group, and I_u is the incidence in the unexposed group. If the risk of an adverse event is increased by the exposure rather than decreased, the term relative risk increase (RRI) is used, and it is computed as (I_e - I_u)/I_u. If the direction of risk change is not assumed, the term relative effect is used, and it is computed in the same way as relative risk increase. Numerical examples Risk reduction Risk increase See also * Population Impact Measures * Vaccine efficacy Vaccine efficacy or vaccine effectiveness is the percentage reduction of disease cases in a vaccinated group of people compared to an unvaccinated group. For example, a vaccine efficacy or effectiveness of 80% indicates an 80% decrease in the ... Ref ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sample Size Determination
Sample size determination is the act of choosing the number of observations or replicates to include in a statistical sample. The sample size is an important feature of any empirical study in which the goal is to make inferences about a population from a sample. In practice, the sample size used in a study is usually determined based on the cost, time, or convenience of collecting the data, and the need for it to offer sufficient statistical power. In complicated studies there may be several different sample sizes: for example, in a stratified survey there would be different sizes for each stratum. In a census, data is sought for an entire population, hence the intended sample size is equal to the population. In experimental design, where a study may be divided into different treatment groups, there may be different sample sizes for each group. Sample sizes may be chosen in several ways: *using experience – small samples, though sometimes unavoidable, can result in wide confiden ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Endpoint
Clinical endpoints or clinical outcomes are Outcome measure, outcome measures referring to occurrence of disease, symptom, Medical sign, sign or laboratory abnormality constituting a target outcome in clinical trial, clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ''humane (clinical) endpoint''. The primary endpoint of a clinical trial is the endpoint for which the trial is statistical power, powered. Secondary endpoints are additional endpoints, preferably also pre-specified, for which the trial may not be powered. Surrogate endpoint, Surrogate endpoints are trial endpoints that have outcomes that substitute for a clinical endpoint, often because studying the clinical endpoint is difficult, for example using an increase in blood pressure as a surrogate for death by cardiovascular disease, where strong evidence of a causal link exists. Scope In a general sens ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Confidence Interval
In frequentist statistics, a confidence interval (CI) is a range of estimates for an unknown parameter. A confidence interval is computed at a designated ''confidence level''; the 95% confidence level is most common, but other levels, such as 90% or 99%, are sometimes used. The confidence level represents the long-run proportion of corresponding CIs that contain the true value of the parameter. For example, out of all intervals computed at the 95% level, 95% of them should contain the parameter's true value. Factors affecting the width of the CI include the sample size, the variability in the sample, and the confidence level. All else being the same, a larger sample produces a narrower confidence interval, greater variability in the sample produces a wider confidence interval, and a higher confidence level produces a wider confidence interval. Definition Let be a random sample from a probability distribution with statistical parameter , which is a quantity to be estimate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
HIV Vaccine
An HIV vaccine is a potential vaccine that could be either a preventive vaccine or a therapeutic vaccine, which means it would either protect individuals from being infected with HIV or treat HIV-infected individuals. It is thought that an HIV vaccine could either induce an immune response against HIV (active vaccination approach) or consist of preformed antibodies against HIV (passive vaccination approach). Two active vaccine regimens, studied in the RV 144 and Imbokodo trials, showed they can prevent HIV in some individuals. However, the protection was in relatively few individuals, and was not long lasting. For these reasons, no HIV vaccines have been licensed for the market yet. Difficulties in development In 1984, after it was confirmed that HIV caused AIDS, the United States Health and Human Services Secretary Margaret Heckler declared that a vaccine would be available within two years. However, priming the adaptive immune system to recognize the viral envelope protein ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
STEP Study
The STEP Study was a Phase IIb clinical trial intended to study the efficacy of an experimental HIV vaccine based on a human adenovirus 5 (HAdV-5) vector. The study was conducted in North and South America, the Caribbean, and Australia. A related study (the "Phambili trial") using the same experimental vaccine was conducted simultaneously in South Africa. These trials were co-sponsored by Merck, the HIV Vaccine Trials Network (HVTN), and the National Institute of Allergy and Infectious Diseases (NIAID), and had an Oversight Committee consisting of representatives from these three organizations. In South Africa the trial was overseen by the South African AIDS Vaccine Initiative. These trials were terminated before their scheduled conclusion, when the Data Safety Monitoring Board determined that the vaccine was not preventing HIV infection, and was possibly enhancing susceptibility to HIV infection in some of the study participants. Design The study was a multicenter, double-blinde ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Intervention
A therapy or medical treatment (often abbreviated tx, Tx, or Tx) is the attempted remediation of a health problem, usually following a medical diagnosis. As a rule, each therapy has indications and contraindications. There are many different types of therapy. Not all therapies are effective. Many therapies can produce unwanted adverse effects. ''Medical treatment'' and ''therapy'' are generally considered synonyms. However, in the context of mental health, the term ''therapy'' may refer specifically to psychotherapy. History Before the creating of therapy as a formal procedure, people told stories to one another to inform and assist about the world. The term "healing through words" was used over 3,500 years ago in Greek and Egyptian writing. The term psychotherapy was invented in the 19th century, and psychoanalysis was founded by Sigmund Freud under a decade later. Semantic field The words ''care'', ''therapy'', ''treatment'', and ''intervention'' overlap in a s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Approved Drug
An approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government. This process is usually specific by country, unless specified otherwise. Process by country United States In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. Drug companies seeking to sell a drug in the United States must first test it. The company then sends the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) evidence from these tests to prove the drug is safe and effective for its intended use. A fee is required to make such FDA submission. For financial year 2020, this fee was: for an application requiring clinical data ($2,942,965) and for an application not requiring clinical data ($1,471,4 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Phases Of Clinical Research
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over sever ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
