India plans to audit clinical trials

Clinical Trials Registry--India: redefining the conduct of clinical trials.

Why are clinical trials necessary in India?

Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India abo...

Capacity building for clinical trials in India.

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...

Dosimetry for audit and clinical trials: challenges and requirements

Many important dosimetry audit networks for radiotherapy have their roots in clinical trial quality assurance (QA). In both scenarios it is essential to test two issues: does the treatment plan conform with the clinical requirements and is the plan a reasonable representation of what is actually delivered to a patient throughout their course of treatment. Part of a sound quality program would b...