ABSTRACT
Pharmaceutical companies and other organisations conducting drug clinical trials rely heavily on healthy volunteers for their first into man studies. This by and large involves healthy young men who are on no medication and able to give written consent. Women are not generally considered at this stage of clinical development because of pregnancy or being on a birth control pill. Clinical trials conducted in this phase are primarily confirmatory studies for efficacy and safety profiles of the drug. These are large in size and usually multi-centre, and often multi-country. TeGenero's Monoclonal Antibody Trial in Healthy Human Volunteers (TGN1412) is a new treatment for devastating illnesses such as leukaemia, rheumatoid arthritis and multiple scler. The Medicines and Healthcare products Regulatory Agency report concludes that side-effects seen with the six healthy human volunteers in clinical trials of TGN1412 were drug–related, and also confirms that the company was not at fault in observing standards.
