Pharma Clinical Research Inc

Healthcare through Research


Clinical trials involve controlled scientific experiments on human subjects to test experimental drugs which have completed intensive developmental and laboratory testing.  Trials are generally sponsored and paid for by pharmaceutical companies, and must be conducted according to a strict standard and guidelines set out by the Food and Drug Administration (FDA) in the United States and governing bodies around the world.  The International Conference on Harmonization (ICP) Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.  Compliance with the standard provides public assurance that the rights, safety and wellbeing of trial subjects are the most important considerations in the conduct of trials, and prevail over interests of science and society. 

There are several “Phases” of clinical trials, beginning with Phase I trials on a small number of healthy patients to determine safety, and progressing through Phase II, III, IIIB and IV trials involving increasingly larger numbers of patients with the disease in question to evaluate effectiveness, side effects, dosage, etc.  Only after completion of extensive clinical testing and thorough reviews by the FDA is a new drug approved for use.

The drug approval process is lengthy and costly.  It can take 15 years and cost $1 billion in research and development to bring a new drug to market.  Despite the costs, the number of new drugs in development continues to grow as advances in biopharmaceutical technology, genome mapping, stem cells and nanotechnology provide researchers new and more focused approaches to fighting disease.  As a result, the demand for clinical trials, which already amounts to $30 billion globally, is growing rapidly.   Clinical trials are also becoming more complex and focused, and recruiting suitable patients is a major challenge in traditional markets such as the United States and Europe. 

Online Resources