NCT03098303 - 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)

Molinari N, Suehs C, Vachier I, Pahus L, Halimi L, Gamez AS, Chanez P, Bourdin A
Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials. Clin Trials. 2019 Aug;16(4):440-442. doi
Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N
Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug

Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study

Clinical trial NCT03098303 - References