[in'rəʊl] вносити до списку

Дата конвертації30.11.2018
Розмір48.2 Kb.
Назва файлуClinical Trials.docx
  1   2   3   4   5   6   7   8   9   10

Clinical Trials

Active Vocabulary




adverse reaction


побічна дія






ефективність, сила; дієвість



вносити до списку; реєструвати




observational study


неекспериментальне дослідження

interventional study


інтервенційне дослідження



об'єкт, предмет

compassionate use


благочинно-випробувальне використання



незатверджеиий; що не отримав


realistic option

[ˌrɪə'lɪstɪk 'ɔpʃ(ə)n]

реалістичний вибір

randomized clinical



дослідження методом випадкової вибірки



['evɪd(ə)n(t)s ˌbeɪst


доказова медицина

cohort study


обстеження групи людей

case-control study

[ˌkeɪs kən'trəul]

дослідження методом випадок-контроль







regulatory agency



органи державного регулювання



те, що мається на увазі, припущення

Clinical Trials

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety.

Depending on the type of product and the stage of its development, investigators enrol healthy volunteers and/or patients into small pilot studies initially,

followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single centre in one country to multicenter trials in multiple countries.

Because the clinical trial is designed to test hypotheses and rigorously monitor and assess what happens, clinical trials can be seen as the application of the scientific method, and specifically the experimental step, to understanding human biology.

The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, psychological therapies, or other interventions.

One way of classifying clinical trials is by the way the researchers behave.

  • In an observational study, the investigators observe the subjects and measure their outcomes. The researchers do not actively manage the study.

  • In an interventional study, the investigators give the research subjects a particular medicine or other intervention. Usually, they compare the treated subjects to subjects who receive no treatment or standard treatment. Then the researchers measure how the subjects' health changes.

Another way of classifying trials is by their purpose.

  • Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

  • Screening trials test the best way to detect certain diseases or health conditions.

  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

  • Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

  • Quality of life trials explore ways to improve comfort and the quality of life for individuals with a chronic illness.

  • Compassionate use trials provide partially tested, unapproved therapeutics prior to a small number of patients that have no other realistic options. Usually, this involves a disease for which no effective therapy exists, or a patient that has already attempted and failed all other standard treatments and whose health is so poor that he does not qualify for participation in randomized clinical trials.

A fundamental distinction in evidence-based medicine is between observational studies and randomized controlled trials. Types of observational studies in epidemiology such as the cohort study and the case-control study provide less compelling evidence than the randomized controlled trial. In observational studies, the investigators only observe associations (correlations) between the treatments experienced by participants and their health status or diseases. A randomized controlled trial is the study design that can provide the most compelling evidence that the study treatment causes the expected effect on human health.

Clinical trials are only a small part of the research that goes into developing a new treatment. Potential drugs, for example, first have to be discovered, purified, characterized, and tested in laboratories (in cell and animal studies) before ever undergoing clinical trials. In all, about 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial. For example, a new cancer drug has, on average, 6 years of research behind it before it even makes it to clinical trials. But the major holdup in making new cancer drugs available is the time it takes to complete clinical trials themselves. On average, about 8 years pass from the time a cancer drug enters clinical trials until it receives approval from regulatory agencies for sale to the public. Drugs for other diseases have similar timelines.

Поділіться з Вашими друзьями:
  1   2   3   4   5   6   7   8   9   10

База даних захищена авторським правом ©refua.in.ua 2019
звернутися до адміністрації

    Головна сторінка
Контрольна робота
Методичні вказівки
Лабораторна робота
навчальної дисципліни
Методичні рекомендації
Загальна характеристика
курсової роботи
використаної літератури
Список використаної
Курсова робота
охорони праці
курсу групи
Пояснювальна записка
Зміст вступ
Виконав студент
Виконала студентка
самостійної роботи
Історія розвитку
форми навчання
навчальних закладів
Теоретичні основи
Міністерство освіти
студент групи
Робоча програма
вищої освіти
Практична робота
молодших школярів
навчальний заклад
виконання курсової
Конспект лекцій
Загальні відомості
роботи студентів
діяльності підприємства
виробничої практики
Практичне заняття
Охорона праці
інтелектуальної власності
використаних джерел
контрольної роботи
охорони здоров
Курсовая работа
Історія виникнення
Самостійна робота
студентка курсу
навчального закладу
загальна характеристика
студентів спеціальності
студентка групи
світової війни
фізичної культури
фізичного виховання