We provide simple statistics tools, clinical trial design, and clinical epidemiology for the evaluation and analysis of clinical trials on treatments.
To test the suitability of NGAL as such a tool, clinical trials using point-of-care pNGAL and uNGAL testing should be designed to predict which patients will meet the criteria for AKI.
Genomic prognostic tests are also increasingly used as patient selection tools for clinical trials and to define clinically relevant patient populations for drug development.
Health Decisions specializes in developing electronic tools for clinical trials, competing with Quintiles Transnational and others in the trial outsourcing business.
The US Food and Drug Administration FDAA) has established a pathway for rigorous development of disease-specific Patient-reported Outcome (PRO) tools for clinical trials and clinical use.
There are many important lessons to be learned from existing assessment tools and clinical trials.
These efforts are essential to establish the Elispot assay and other immune assays as standard monitoring tools for clinical trials.
It is fair to say that, regardless of any standardization of design, treatments and assessment tools, many clinical trials have unique features regarding their methods and/or their implementation.
While there are an increasing number of studies using microarrays and/or quantitative real time PCR as immune monitoring tools in clinical trials, there have been few studies assessing the contribution of the RNA purification method to the expressed gene profile.
The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) is a well-known diagnostic tool for clinical trials on TMD.
