MedlinePlus Health Topics

Last uploaded: April 29, 2019
Preferred Name

Clinical Trials

Definitions

<p>Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.</p> <p>Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.</p> <p>An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to</p> <ul> <li>Make sure that the study is ethical</li> <li>Protect the rights and welfare of the participants</li> <li>Make sure that the risks are reasonable when compared to the potential benefits</li> </ul> <p>In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.</p> <p >NIH: National Institutes of Health</p>

ID

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0008976

cui

C0008976

Date created

02/29/2000

definition

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to

  • Make sure that the study is ethical
  • Protect the rights and welfare of the participants
  • Make sure that the risks are reasonable when compared to the potential benefits

In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.

NIH: National Institutes of Health

Inverse of SIB

http://purl.bioontology.org/ontology/MEDLINEPLUS/C2362520

http://purl.bioontology.org/ontology/MEDLINEPLUS/C1113679

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0018739

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0030706

http://purl.bioontology.org/ontology/MEDLINEPLUS/C2362328

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0001683

http://purl.bioontology.org/ontology/MEDLINEPLUS/C1456713

http://purl.bioontology.org/ontology/MEDLINEPLUS/C1456650

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0015004

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0030231

http://purl.bioontology.org/ontology/MEDLINEPLUS/C1456522

http://purl.bioontology.org/ontology/MEDLINEPLUS/C2362527

Mapped from

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0008976

Mapped to

http://purl.bioontology.org/ontology/MEDLINEPLUS/C0008976

MP HEALTH TOPIC URL

https://medlineplus.gov/clinicaltrials.html

MP OTHER LANGUAGE URL

Spanish https://medlineplus.gov/spanish/clinicaltrials.html

French https://medlineplus.gov/languages/clinicaltrials.html#French

Chinese, Traditional (Cantonese dialect) https://medlineplus.gov/languages/clinicaltrials.html#Chinese, Traditional (Cantonese dialect)

Spanish https://medlineplus.gov/languages/clinicaltrials.html#Spanish

Russian https://medlineplus.gov/languages/clinicaltrials.html#Russian

Korean https://medlineplus.gov/languages/clinicaltrials.html#Korean

Hindi https://medlineplus.gov/languages/clinicaltrials.html#Hindi

Arabic https://medlineplus.gov/languages/clinicaltrials.html#Arabic

Polish https://medlineplus.gov/languages/clinicaltrials.html#Polish

Vietnamese https://medlineplus.gov/languages/clinicaltrials.html#Vietnamese

notation

C0008976

prefLabel

Clinical Trials

Related to

http://purl.bioontology.org/ontology/MEDLINEPLUS/C2362328

tui

T062

subClassOf

http://purl.bioontology.org/ontology/MEDLINEPLUS/C2362508

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