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Patient Recruitment
Patient recruitment is the process of finding and enrolling suitable participants for clinical trials. It is a crucial aspect of drug development and medical research, as it affects the validity, reliability, and generalizability of the results. Patient recruitment can also be challenging, time-consuming, and costly, involving various ethical, regulatory, and logistical issues. Many factors influence patient recruitment, such as the design and complexity of the trial, the availability and accessibility of the target population, the awareness and motivation of the potential participants, and the competition and collaboration among different stakeholders. To overcome these challenges, patient recruitment service providers offer various solutions, such as public education, patient outreach, site support, and data analytics. These services aim to increase the enrollment rate, reduce the dropout rate, and improve the quality and diversity of the trial participants. Patient recruitmen ...
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) 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 institutional review board, 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. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ...
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Twitter
Twitter, officially known as X since 2023, is an American microblogging and social networking service. It is one of the world's largest social media platforms and one of the most-visited websites. Users can share short text messages, images, and videos in Microblogging, short posts commonly known as "Tweet (social media), tweets" (officially "posts") and Like button, like other users' content. The platform also includes direct message, direct messaging, video and audio calling, bookmarks, lists, communities, a chatbot (Grok (chatbot), Grok), job search, and Spaces, a social audio feature. Users can vote on context added by approved users using the Community Notes feature. Twitter was created in March 2006 by Jack Dorsey, Noah Glass, Biz Stone, and Evan Williams (Internet entrepreneur), Evan Williams, and was launched in July of that year. Twitter grew quickly; by 2012 more than 100 million users produced 340 million daily tweets. Twitter, Inc., was based in San Francisco, C ...
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Mass Media
Mass media include the diverse arrays of media that reach a large audience via mass communication. Broadcast media transmit information electronically via media such as films, radio, recorded music, or television. Digital media comprises both Internet and mobile mass communication. Internet media comprise such services as email, social media sites, websites, and Internet-based radio and television. Many other mass media outlets have an additional presence on the web, by such means as linking to or running TV ads online, or distributing QR codes in outdoor or print media to direct mobile users to a website. In this way, they can use the easy accessibility and outreach capabilities the Internet affords, as thereby easily broadcast information throughout many different regions of the world simultaneously and cost-efficiently. Outdoor media transmits information via such media as augmented reality (AR) advertising; billboards; blimps; flying billboards (signs in tow of airpl ...
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Retrospective Cohort Study
A retrospective cohort study, also called a historic cohort study, is a longitudinal cohort study used in medical and psychological research. A cohort of individuals that share a common exposure factor is compared with another group of equivalent individuals not exposed to that factor, to determine the factor's influence on the incidence of a condition such as disease or death. Retrospective cohort studies have existed for approximately as long as prospective cohort studies. Design The retrospective cohort study compares groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke and ones who do not smoke) in terms of a particular outcome (such as lung cancer). Data on the relevant events for each individual (the form and time of exposure to a factor, the latent period, and the time of any subsequent occurrence of the outcome) are collected from existing records and can immediately be analyzed to determine the ...
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E6-GCP
This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. Regulatory guidances (draft and/or final ) are subject to revisions. Therefore, users of the guidances are advised to consult the original website to check for the latest version. Users are also encouraged to update the Wikipedia List. References classified by statistical topic Good clinical practice * ICH E6(R2): Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. * FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. This good review practice (GRP) ...
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Alzheimer's Disease
Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems with language, disorientation (including easily getting lost), mood swings, loss of motivation, self-neglect, and behavioral issues. As a person's condition declines, they often withdraw from family and society. Gradually, bodily functions are lost, ultimately leading to death. Although the speed of progression can vary, the average life expectancy following diagnosis is three to twelve years. The causes of Alzheimer's disease remain poorly understood. There are many environmental and genetic risk factors associated with its development. The strongest genetic risk factor is from an allele of apolipoprotein E. Other risk factors include a history of head injury, clinical depression, and high blood pressure. The progression of the di ...
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Caregiver
A caregiver, carer or support worker is a paid or unpaid person who helps an individual with activities of daily living. Caregivers who are members of a care recipient's family or social network, who may have specific professional training, are often described as informal caregivers. Caregivers most commonly assist with impairments related to old age, disability, a disease, or a mental disorder. Typical duties of a caregiver might include taking care of someone who has a chronic illness or disease; managing medications or talking to doctors and nurses on someone's behalf; helping to bathe or dress someone who is frail or disabled; or taking care of household chores, meals, or processes both formal and informal documentations related to health for someone who cannot do these things alone. With an aging population in all developed societies, the role of caregivers has been increasingly recognized as an important one, both functionally and economically. Many organizations that provi ...
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Performance Metric
A performance indicator or key performance indicator (KPI) is a type of performance measurement. KPIs evaluate the success of an organization or of a particular activity (such as projects, programs, products and other initiatives) in which it engages. KPIs provide a focus for strategic and operational improvement, create an analytical basis for decision making and help focus attention on what matters most. Often success is simply the repeated, periodic achievement of some levels of operational goal (e.g. zero defects, 10/10 customer satisfaction), and sometimes success is defined in terms of making progress toward strategic goals. Accordingly, choosing the right KPIs relies upon a good understanding of what is important to the organization. What is deemed important often depends on the department measuring the performance – e.g. the KPIs useful to finance will differ from the KPIs assigned to sales. Since there is a need to understand well what is important, various technique ...
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Monitoring In Clinical Trials
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards. Safety monitoring Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis. ...
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Direct Mail
Advertising mail, also known as direct mail (by its senders), junk mail (by its recipients), mailshot or admail (North America), letterbox drop or letterboxing (Australia), is the delivery of advertising material to recipients of postal mail. The delivery of advertising mail forms a large and growing service for many postal services, and direct-mail marketing forms a significant portion of the direct marketing industry. Some organizations attempt to help people opt out of receiving advertising mail, in many cases motivated by a concern over its negative environmental impact. Advertising mail includes advertising circulars, plastic mailers, coupon envelopes (Money Mailer, Valpak), catalogs, CDs, " pre-approved" credit card applications, and other commercial merchandising materials delivered to homes and businesses. It may be addressed to pre-selected individuals, or unaddressed and delivered on a neighbourhood-by-neighbourhood basis. Origin North Carolina state historians ...
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Support Group
In a support group, members provide each other with various types of help, usually nonprofessional and nonmaterial, for a particular shared, usually burdensome, characteristic. Members with the same issues can come together for sharing coping strategies, to feel more empowered and for a sense of community. The help may take the form of providing and evaluating relevant information, relating personal experiences, listening to and accepting others' experiences, providing sympathetic understanding and establishing social networks. A support group may also work to inform the public or engage in advocacy. History Formal support groups may appear to be a modern phenomenon, but they supplement traditional fraternal organizations such as Freemasonry in some respects, and may build on certain supportive functions (formerly) carried out in (extended) families. Other types of groups formed to support causes, including causes outside of themselves, are more often called '' advocacy groups' ...
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Health Fair
A health fair is an educational and interactive event designed for outreach to provide basic preventive medicine and medical screening to people in the community or employees at work in conjunction with workplace wellness. It can also be a public health intervention. Health fairs are typically offered in the community, on site corporations, work sites, churches or schools. The consist of a variety of vendors and exhibitors that educate on all aspects of health, wellness, fitness and lifestyle improvements. Topics can include such things as chiropractic, acupuncture, fitness clubs and hospitals. It is very common to see health screenings such as cholesterol testing or blood pressure screenings. Health Fairs are advertised and promoted ahead of time by print media, radio, or television and are usually a one-day event. Health fairs are often organized and run by professional health fair organization companies but can also be done by medical providers, benefits directors, medic ...
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