The need for endpoints in anticancer drug trials that will simplify the clinical decision-making process.

The endpoints relating to antitumour effect which are commonly used are limited in that they give no information about the effect of the treatment on the person with cancer. This is particularly important in those many situations where cure is not a viable option. The use of quality of life as an endpoint may help to overcome this problem, but limitations remain. New endpoints, which simplify the clinical decision-making process in terms of the potential impact of treatment on the individual patient, are now needed. A variety of factors must be considered when evaluating the efficacy of an anticancer agent, including such issues as whether the drug is easy to use. Despite the complications this will present, in terms of the planning and implementing of clinical trials, the long-term benefits to patients and healthcare professionals would fully justify the investment of time and multidisciplinary expertise involved.