phase I, II, III clinical trials

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'phase I, II, III clinical trials' can also refer to...

phase I, II, III clinical trials

phase I, II, III clinical trials

Results of phase I/II clinical trials with ezetimibe, a novel selective cholesterol absorption inhibitor

A robust Bayesian dose-finding design for phase I/II clinical trials

A randomized Phase III trial of lobe-specific vs. systematic nodal dissection for clinical Stage I–II non-small cell lung cancer (JCOG1413)

Prolongation of repolarization in pre-clinical investigations and phase I/II clinical trials: what should be done?


Characteristics of pyrexia in BRAF V600E/K metastatic melanoma patients treated with combined dabrafenib and trametinib in a phase I/II clinical trial

Final report of the phase I/II clinical trial of the E75 (nelipepimut-S) vaccine with booster inoculations to prevent disease recurrence in high-risk breast cancer patients

Ifosfamide given by continuous-intravenous infusion in association with vinorelbine in patients with anthracycline-resistant metastatic breast cancer: A phase I–II clinical trial

A phase I-II study of 9-cis retinoic acid and interferon-α2b in patients with advanced renal-cell carcinoma: An NCIC Clinical Trials Group study

Severe acute thrombotic exacerbation in two cases with anti-phospholipid syndrome after retreatment with rituximab in phase I/II clinical trial for refractory systemic lupus erythematosus

A Phase I/II Trial of Chemoradiotherapy Concurrent with S-1 plus Mitomycin C in Patients with Clinical Stage II/III Squamous Cell Carcinoma of Anal Canal (JCOG0903: SMART-AC)

A Phase I/II Trial of Radiotherapy Concurrent with TS-1 Plus Cisplatin in Patients with Clinically Resectable Type 4 or Large Type 3 Gastric Cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group OGSG1205

Safety and Immunogenicity of an Inactivated Influenza A/H5N1 Vaccine Given with or without Aluminum Hydroxide to Healthy Adults: Results of a Phase I–II Randomized Clinical Trial


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Clinical trials of new drugs and vaccines begin with a phase I trial on a small number, typically fewer than 50, of healthy volunteers to study pharmacological properties, mode of action, and safety. A phase I trial also can test routes of administration and doses. A phase II trial is the initial trial of efficacy, a small randomized trial (perhaps 200 to 300 participants) to compare the safety and efficacy of the new drug with existing alternatives. A phase III trial is a larger study, with perhaps thousands of volunteer participants with random allocation and sometimes multiple study centers. All phases require ethical review and an assurance that informed consent requirements have been met.

Subjects: Public Health and Epidemiology.

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