NCT02087293 - 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)

Haas JS, Amato M, Marinacci L, Orav EJ, Schiff GD, Bates DW
Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting. Drug Saf. 2012 Aug 1;35(8):623-8. doi: 10.2165/11630650-000000000-00000.
Haas JS, Iyer A, Orav EJ, Schiff GD, Bates DW
Participation in an ambulatory e-pharmacovigilance system. Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):961-9. doi: 10.1002/pds.2006.
Haas JS, Klinger E, Marinacci LX, Brawarsky P, Orav EJ, Schiff GD, Bates DW
Active pharmacovigilance and healthcare utilization. Am J Manag Care. 2012 Nov 1;18(11):e423-8.
Linder JA, Haas JS, Iyer A, Labuzetta MA, Ibara M, Celeste M, Getty G, Bates DW
Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf. 2010 Dec;19(12):1211-5.

e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse Reactions

Clinical trial NCT02087293 - References