Clinical Interventional Study

From GM-RKB
(Redirected from clinical trial)
Jump to: navigation, search

A Clinical Interventional Study is a prospective clinical study that is an intervention study (which attempts to assess the efficacy of a clinical investigational product).



References

2022

  • (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-3-20.
    • Investigational
      • In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental. (NCI)

2021

2020

  • (Gene Vision, 2020) ⇒ https://gene.vision/knowledge-base/clinical-trials/
    • QUOTE: ... A clinical trial is a research study conducted in human volunteers to assess whether a new intervention is safe and effective for a specific condition. The intervention tested can either be a new drug, a device, a procedure or even changes to a participants’ behaviour (such as dieting). It is normally tested against a current standard treatment, a placebo or no intervention.

      Trials are conducted by research teams led by a principal investigator, who is usually an expert in the condition and the intervention being studied. The trials may be conducted in only one centre (single-centre trial) or in multiple centres (multicentre trials). Credible trials are strictly regulated and have obtained ethical approval. Funding of clinical trials can come from a variety of sources. These include pharmaceutical companies, medical research councils, universities, charities or a combination of these sources. ...

2020

  • (ClinicalTrial.gov, 2020) ⇒ https://clinicaltrials.gov/ct2/about-studies/learn#ClinicalTrials
    • QUOTE: ... In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. ...

2018

2014

2012

2010

  • (ClinicaTrials.gov, 2010) ⇒ ClinicalTrials.gov. (2009). “Glossary of Clinical Trials Terms." (2010-09-21)
    • QUOTE: CLINICAL TRIAL: A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (See Phase I, II, III, and IV Trials).

2008

2004