From lab to licencing Initial research on all new medicines is carried out in the laboratory, where hundreds of thousands of different compounds can be studied by scientists. The research and testing stage often takes years If there is a compound that they think could be a winner, it is then tested on animals, as required by the regulatory authorities worldwide. Three phases of clinical trials on humans then follows. The third phase will be a large study with many, say 1,000-3,000 patients, taking the medicine under supervision for an appropriate period. In the UK, the MCA then refers the data to the Committee on Safety of Medicines which, if satisfied by the evidence, will recommend the MCA issue a licence.
Doctors can then prescribe it.
This was the organisation that backtracked on an earlier decision in the case of the flu drug Relenza. Most advances are made in small steps rather than giant leaps. British Biotech One company that might feel it could do with a dose of luck is the UK drugs group British Biotech. Its shares tumbled earlier this year after the company admitted that the latest trial of its cancer treatment drug marimastat produced no benefits to patient survival rates for an aggressive form of brain cancer. The firm, which is trialing several drugs at varying phases of development, has seen its share price plummet, from a peak set four years ago of 326.5p to its low point of 16p recorded in April 1999.