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intervetionsprövning, interventionell prövning

interventional trial [ENGLISH]

An interventional trial sets up to discover or verify the effects of one or more investigational medicinal product(s) (IMP), to ascertain its (their) safety and/or efficacy. The assignment of the patient to a particular therapeutic strategy is decided in advance by a trial protocol. The way the IMP(s) are used, and the way the patients are selected for the trial and followed up are not as per current practice, and the data from the trial are systematically analysed.

intervetionsprövning, interventionell prövning [SWEDISH]

En interventionell prövning syftar till att upptäcka eller verifiera effekterna av ett eller flera prövningsläkemedel (IMP), för att fastställa dess (deras) säkerhet och/eller effekt. Tilldelningen av patienten till en viss terapeutisk strategi bestäms i förväg av ett försöksprotokoll. Sättet som IMP(erna) används och hur patienterna väljs ut för prövningen och följs upp är inte enligt nuvarande praxis, och data från prövningen analyseras systematiskt.

2024-01-29

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Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary https://www.asgct.org/education/more-resources/glossary
  2. 2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
  3. 3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
  4. 4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
  5. 5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
  6. 6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary https://toolkit.ncats.nih.gov/glossary-2/

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