Quality Management in Clinical Trials

Evaluation of Clinical Trials

In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...

Quality Assurance for Clinical Trials

Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RP...

Seeking harmonization and quality in clinical trials.

Assessing quality of life in clinical trials.

• Complete revision and update to cover the increased breadth and importance of the field of QoL measurement • A rigorous, broad comprehensive coverage of all aspects of QoL measurement, methods and practice • Gives a new focus on qualitative methods which have become considerably more advanced and now have a stronger scientific basis • Introduces Rasch models and item response theory, the use ...

Developing Effective Quality Systems in Clinical Trials: