On the role of clinical total quality management in clinical research and health care

cTQM known as clinical total quality management is a revolutionary approach in Quality Management. Implementation of cTQM in clinical research is a novel process. In the clinical research domain, cTQM is solely responsible and is focused on customer satisfaction. In future, cTQM is the way of managing quality in the clinical research, and is far wider in its application than just assuring product or service quality - it is a way of managing people and business processes to ensure complete customer satisfaction at every stage, internally and externally. cTQM, combined with effective leadership, results in an organization doing the right things right, first time. Clinical research including trials is an investigation in humans anticipated to decide or confirm the effects of a drug or to identify any adverse reactions with an intention of ascertaining its safety and efficacy. Quality of clinical trials relies on data consistency and subject safety. Quality control and quality assurance are part of quality management. There is an increasing focus on having quality systems in place throughout the planning stages of clinical trials. The regulatory outline for clinical trials has altered in recent years with the addition of thorough controls to guarantee patient protection and data dependability. Clinical research for human health has grown exponentially over the past decade because of cost advantage, treatment naive patient, qualified doctors conversant in English etc. India has been the second most preferred country to conduct clinical trials outside the US in 2009. However, recent years have witnessed a decline in number of trials in India. The number of drugs entering the Indian markets had been gradually reducing even before the current slump in clinical research activity largely due to quality issues. Thus, the role of quality in clinical research and trials assumes extreme significance, looking to the rapidly developing health care system across the world in future.