Over the last 30 years – there is enormous expansion of pharmaceutical research and clinical trials in the quest
for new and effective drugs . Many advances are taking place in the area of clinical trials. Thousands of compounds
undergo extensive clinical testing for every new chemical entity (NCE) that receives marketing approval . Clinical trials
are the backbone of human therapeutic development process and require careful planning and control to ensure clinical
effectiveness and safety of patients . Clinical trials are gaining high importance due to advancement in technology and
invention of new molecules in healthcare sector. Each patient battling with a disease or managing a condition lives in the
hope that tomorrow will bring a new medicine that delivers better health. Scientists and research companies all over the
world are working relentlessly and untiringly to achieve the same goal of developing new drugs and medical devices that
can prevent diseases, improve patients’ health, and save lives. Over the last decade, US - FDA has approved more than
300 new drugs and around 500 new medical devices [4, 5] – all this is possible only with a systematic and scientific approach
in conducting the clinical trials.
Keywords: Clinical research, Drug development, New chemical entity, Drug delivery technology, Safety regulations.
Rights & PermissionsPrintExport