THE NEED FOR END-POINTS IN ANTICANCER DRUG TRIALS THAT WILL SIMPLIFY THE CLINICAL DECISION-MAKING PROCESS

The endpoints relating to antitumour effect which are commonly used ar e limited in that they give no information about the effect of the tre atment on the person with cancer. This is particularly important in th ose many situations where cure is not a viable option. The use of qual ity of life as an endpoint may help to overcome this problem, but limi tations remain. New endpoints, which simplify the clinical decision-ma king process in terms of the potential impact of treatment on the indi vidual patient, are now needed. A variety of factors must be considere d when evaluating the efficacy of an anticancer agent, including such issues as whether the drug is easy to use. Despite the complications t his will present, in terms of the planning and implementing of clinica l trials, the long-term benefits to patients and healthcare profession als would fully justify the investment of time and multidisciplinary e xpertise involved. (C) 1997 Elsevier Science Ltd.