Responder Identification in Clinical Trials

Responder identification in clinical trials with censored data

The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomes

BACKGROUND Traditionally in acute stroke clinical trials, the primary clinical outcome employed is a dichotomized modified Rankin Scale (mRS). New statistical methods, such as responder analysis, are being used in stroke studies to address the concern that baseline prognostic variables, such as stroke severity, impact the likelihood of a successful outcome. Responder analysis allows the definit...

Development of responder definitions for fibromyalgia clinical trials.

OBJECTIVE To develop responder definitions for fibromyalgia (FM) clinical trials using key symptom and function domains. METHODS Twenty-four candidate responder definitions were developed by expert consensus and were evaluated in 12 randomized, placebo-controlled trials of 4 medications for the treatment of FM. For each definition, the treatment effects of the medication compared with placebo...

Clopidogrel Resistance and its Impact on Clinical Outcome of Iranian Patients Undergoing Percutaneous Coronary Intervention

The aim of current study was evaluating the frequency of clopidogrel resistance and its impact on clinical outcome of patients in Iranian patients. Patients undergoing percutaneous coronary intervention in Imam Hussein Medical center, Tehran, Iran, who received standard dosage of clopidogrel (Plavix®, Sanofi, France, 600 mg loading dose and 75 mg/day afterward) were recruited. Platelet aggregat...

Clopidogrel Resistance and its Impact on Clinical Outcome of Iranian Patients Undergoing Percutaneous Coronary Intervention

The aim of current study was evaluating the frequency of clopidogrel resistance and its impact on clinical outcome of patients in Iranian patients. Patients undergoing percutaneous coronary intervention in Imam Hussein Medical center, Tehran, Iran, who received standard dosage of clopidogrel (Plavix®, Sanofi, France, 600 mg loading dose and 75 mg/day afterward) were recruited. Platelet aggregat...