Pharmacy Practice and Clinical Research
Pharmacy Practice and Clinical Research in NIPER JEE tests hospital and community pharmacy, clinical pharmacy services, pharmacovigilance, GCP, and trial design.
Core rules and concepts
- Trial phases: Phase I usually healthy volunteers for safety/PK; Phase II patients for efficacy/dose; Phase III larger comparative efficacy; Phase IV post-marketing surveillance.
- GCP requires IRB/IEC approval, informed consent, protocol adherence, source documentation, monitoring, and audit. Randomization and allocation concealment reduce selection bias; blinding reduces measurement bias.
- Pharmacovigilance: ADR is an unintended harmful response to a drug at normal doses; an ADE may not be causally related. Serious ADRs cause death, hospitalization, disability, or congenital anomaly.
- NNT = 1/ARR; ARR = control event rate − treatment event rate. NNH = 1/ARI.
- Intention-to-treat preserves randomization; per-protocol can exaggerate efficacy.
Worked example
In a trial, the event rate is 5% with placebo and 2% with drug. ARR = 5% − 2% = 3% = 0.03. NNT = 1/0.03 = 33.3, rounded up to 34. This means about 34 patients must be treated for one additional event to be prevented over the study period.
Traps that cost marks
- Placing Phase I in patients by default; oncology and toxic drugs are exceptions.
- Confusing superiority with noninferiority; noninferiority needs a prespecified margin.
- Reporting NNT without the time frame and baseline risk.
- Treating an ADE as an ADR without causality assessment.