NCT05398471 - 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)

Lansey DG, Hefka TA, Carducci MA, Kanarek NF
Problem Solving to Enhance Clinical Trial Participation Utilizing a Framework-Driven Approach. Clin Adv Hematol Oncol. 2020 Aug;18(8):468-476.
McKinney M, Bell R, Samborski C, Attwood K, Dean G, Eakle K, Yu W, Edge S
Clinical Trial Participation: A Pilot Study of Patient-Identified Barriers. Clin J Oncol Nurs. 2021 Dec 1;25(6):647-654. doi: 10.1188/21.CJON.647-654.
Michos ED, Van Spall HGC
Increasing representation and diversity in cardiovascular clinical trial populations. Nat Rev Cardiol. 2021 Aug;18(8):537-538. doi: 10.1038/s41569-021-00583-8. No abstract available.

Observational Clinical Trial Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients Participating In Clinical Research

Clinical trial NCT05398471 - References