NCT05124119 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Byrne MM, Tannenbaum SL, Gluck S, Hurley J, Antoni M
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Hayen A, Wanigasekera V, Faull OK, Campbell SF, Garry PS, Raby SJM, Robertson J, Webster R, Wise RG, Herigstad M, Pattinson KTS
Opioid suppression of conditioned anticipatory brain responses to breathlessness. Neuroimage. 2017 Apr 15;150:383-394. doi: 10
Hedegaard H, Spencer MR, Garnett MF
Increase in Drug Overdose Deaths Involving Cocaine: United States, 2009-2018. NCHS Data Brief. 2020 Oct;(384):1-8.
Magruder KM, Bichun Ouyang, Miller S, Tilley BC
Retention of under-represented minorities in drug abuse treatment studies. Clin Trials. 2009 Jun;6(3):252-60. doi: 10.1177/1740774509105224.
Murthy VH, Krumholz HM, Gross CP
Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004 Jun 9;291(22):2720-6. doi: 10.1001/jama.291.22.2720.

Innovative Development of Research Engagement Manual (I-DREM): Strategies to Enhance Recruitment and Retention of African American/Black Individuals in Clinical Trials

Details for clinical trial NCT05124119

Clinical trial NCT05124119 - References