Data Monitoring Committees

Data Monitoring Committees

Frederic P. Miller, Agnes F. Vandome, John McBrewster

     

бумажная книга



Издательство: Книга по требованию
Дата выхода: июль 2011
ISBN: 978-6-1338-2490-4
Объём: 76 страниц
Масса: 135 г
Размеры(В x Ш x Т), см: 23 x 16 x 1

High Quality Content by WIKIPEDIA articles! A Data Monitoring Committee (DMC) — sometimes called a Data and Safety Monitoring Board (DSMB) — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. Many randomized clinical trials are double blind, i.e. no one involved with the trial knows what treatment was given to the trial participant. This includes the participant, their doctor, and even the study personnel at the company that is sponsoring the trial. There are many extremely good reasons to conduct a trial in this manner and only after the trial database is finalized is the blind broken and the true treatment assignments disclosed. However, these trials may go for years and there is justifiably concern about enrolling participants and exposing them to an unproven treatment without someone overseeing results. The company sponsoring the trial is blinded, so they can't perform this service. Even if they had some people who were unblinded to the results, they would be in an awkward position between concern for their corporate interests and concern for the trial participants.

Данное издание не является оригинальным. Книга печатается по технологии принт-он-деманд после получения заказа.

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