Abstract
Patient recruitment and retention currently represents a critical bottleneck in clinical research
and drug development. For example, in some cases, (e.g. breast cancer in the USA) the supply of
patients may be inadequate to fully assess all the drugs currently in the pipeline. Furthermore,
clinical studies account for around half of the billion-dollar cost of drug development. Clinical
studies are also becoming larger, longer and more complex. Therefore, there is a pressing need to
reduce costs and get drugs to market more rapidly. But many clinical studies are both ineffective
and inefficient. Some 70% of sites miss their recruitment target, for example. The report covers the
scientific aspects that contribute to the bottleneck, including enrolling of an appropriate race,
age and pharmacogenomic profile to represent patients likely to receive the drug in clinical
practice and access to naive patient populations. |