32 Facts About Clinical trials

1.

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.

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2.

Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries.

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3.

Some clinical trials involve healthy subjects with no pre-existing medical conditions.

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4.

Clinical trials included a dietary supplement of an acidic quality in the experiment after two months at sea, when the ship was already afflicted with scurvy.

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5.

Clinical trials divided twelve scorbutic sailors into six groups of two.

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6.

Clinical trials founded the Collective Investigation Record for the British Medical Association; this organization collected data from physicians practicing outside the hospital setting and was the precursor of modern collaborative clinical trials.

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7.

Methodology of clinical trials was further developed by Sir Austin Bradford Hill, who had been involved in the streptomycin trials.

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8.

Clinical trials became famous for a landmark study carried out in collaboration with Richard Doll on the correlation between smoking and lung cancer.

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9.

Acronyms used in the titling of clinical trials is often contrived, and has been the subject of derision.

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10.

Clinical trials are classified by the research objective created by the investigators.

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11.

Clinical trials are conducted typically in four phases, with each phase using different numbers of subjects and having a different purpose to construct focus on identifying a specific effect.

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12.

Clinical trials involving new drugs are commonly classified into five phases.

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13.

Phase IV Clinical trials are performed after the newly approved drug, diagnostic or device is marketed, providing assessment about risks, benefits, or best uses.

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14.

Currently, some Phase II and most Phase III drug Clinical trials are designed as randomized, double-blind, and placebo-controlled.

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15.

Clinical trials trial protocol is a document used to define and manage the trial.

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16.

Clinical trials recruit study subjects to sign a document representing their "informed consent".

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17.

Many Clinical trials are doubled-blinded so that researchers do not know to which group a subject is assigned.

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18.

Clinical trials are only a small part of the research that goes into developing a new treatment.

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19.

Some drug Clinical trials require patients to have unusual combinations of disease characteristics.

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20.

Clinical trials that do not involve a new drug usually have a much shorter duration.

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21.

Clinical trials designed by a local investigator, and federally funded clinical trials, are almost always administered by the researcher who designed the study and applied for the grant.

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22.

Patients who are less likely to talk about clinical trials are more willing to use other sources of information to gain a better insight of alternative treatments.

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23.

Web-based electronic data capture and clinical data management systems are used in a majority of clinical trials to collect case report data from sites, manage its quality and prepare it for analysis.

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24.

The International Conference of Harmonisation Guidelines for Good Clinical Practice is a set of standards used internationally for the conduct of clinical trials.

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25.

The US Congress signed into law a bill which requires PhaseII and PhaseIII clinical trials to be registered by the sponsor on the clinicaltrials.

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26.

In 2001, the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication.

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27.

Inclusion of children in clinical trials has additional moral considerations, as children lack decision-making autonomy.

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28.

International guidance recommends ethical pediatric Clinical trials by limiting harm, considering varied risks, and taking into account the complexities of pediatric care.

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29.

FDA regulations state that participating in clinical trials is voluntary, with the subject having the right not to participate or to end participation at any time.

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30.

Benefits of conducting Clinical trials abroad include lower costs and the ability to run larger Clinical trials in shorter timeframes, whereas a potential disadvantage exists in lower-quality trial management.

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31.

Phase II Clinical trials ranged from $7 million to $20 million, and PhaseIII Clinical trials from $11 million to $53 million.

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32.

Participants in Phase I drug Clinical trials do not gain any direct health benefit from taking part.

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