Clinical trials design and registry definition

Clinical trials design and registry definition

Clinical trials are categorized as Phase I to IV trials. Roche Pharmaceuticals defines the Phase I to IV clinical trials as follows: Phase I (small number of healthy volunteers; in certain cases, i.e. virology/oncology, also patients) Phase I studies…

Clinical trial designed for HCV patients

Clinical trial designed for HCV patients

High Quality/High Throughput HCV resistance or virologic data is required by regulatory agencies for evaluation of HCV drug candidates. Janssen Diagnostics provides sequencing assays that characterize mutations which may lead to resistance following exposure…

Clinical trials design review

Clinical trials design review

Rebecca Kirk & Lisa Hutchinson doi:10.1038/nrclinonc.2012.33 Nature Reviews Clinical Oncology 9, 185-186 (2012) Adaptive clinical trials in oncology Donald A. Berry doi:10.1038/nrclinonc.2011.165 Nature Reviews Clinical Oncology 9, 199-207 (2012)…

Clinical trials phases and design

Clinical trials phases and design

Although less than 5% of patients with cancer are enrolled in clinical trials, such trials represent an important step between basic cancer research and clinical practice.1 Clinical trials serve as the basis for evidence-based medicine by addressing specific…

Group sequential designs clinical trials

Group sequential designs clinical trials

SUMMARY In clinical trials with sequential patient entry, fixed sample size designs are unjustified on ethical grounds and sequential designs are often impracticable. One solution is a group sequential design dividing patient entry into a number of equal-sized…

Clinical trials in drug design

Clinical trials in drug design

Nature Reviews Drug Discovery 5, 133-146 doi:10.1038/nrd1956 Abstract More than 50 years after the introduction of modern pharmacotherapies for schizophrenia, there remains a tremendous need for therapeutic advances. A second generation of antipsychotic…

Clinical trial protocol design

Clinical trial protocol design

The study design of a clinical trial is the scientific road-map for the study. An important element of the study design is the protocol, which contains a high-level description of the reasoning behind and the schedule for every activity that will occur…

Clinical trial design for Medical Devices

Clinical trial design for Medical Devices

We begin the design of your medical device clinical trial with the formulation of appropriate study endpoints. Whether you need to collect data to support an FDA pre-market submission, a scientific publication, or drive physician adoption and market acceptance…