Published on February 19, 2014
Basic Concepts in Small Doses 6 Weam Banjar; BDS., MS.
Disclosure • • None Basic concepts in small doses highlights basic concepts in research particularly in areas of concerns for health care professionals Banjar WM
Phases of Clinical Trial Banjar WM
Phase I • • • • New investigational drug Sample size: small ( ~ 50-100) Healthy volunteer Objective: assess safety, determine safe dose range, identify adverse events Banjar WM
Phase II • • • Controlled clinical trial Sample size: several hundreds Objective: assess effectiveness and further assess safety Banjar WM
Phase III • • • Randomized clinical trial Sample size: several thousands Objective: assess effectiveness, monitor side effects, compare efficacy to current standard of care Banjar WM
Phase IV • • Post-marketing surveillance Collect information on long term effect of marketed drug Banjar WM
Good Luck Banjar WM
Summary of clinical trial phases; Phase Primary goal Dose ... very small, subtherapeutic: clinical researcher: ...  Phase III This phase is ...
At a different dose ... The concepts behind clinical trials are ancient. ... randomized studies typical of Phase 3, many clinical trials are small.
Phase I Clinical Trial Design Lawrence V Rubinstein, PhD* Richard M Simon, DSc* Biometric Research Branch, National Cancer Institute 6130 Executive Blvd ...
conduct of human clinical trials is delineated ... 6 months in clinical trials ... WOCBP can be included in repeated- dose Phase I and II trials before ...
What Are Clinical Trials? A critical part in the process of bringing new therapies to patients is clinical development, the study of potential new ...
... are in Phase III clinical trials or for ... way that pre-clinical testing indicated. A small ... of Phase I trials, but the basic premise ...