973 Problems, of drug development and registration in Europe

Abstract

The current European Application Procedures—Centralized, Decentralized, and National—are well adapted to Drug Registration in the ED. The specific problems of anticancer agents—phase I trials in patients, lack of well accepted surrogate end-points, value of phase III single agents trials, role of Quality of Life measures, general use in the context of combination and multimodality therapy—are poorly understood by some Agencies. A better interaction between Oncologists and Agencies is needed as well as clarification of these points. Drug development raises more questions. (1) Only a minority of Early Clinical Trials are performed in Europe. (2) Few indications are targetted—Breast, Lung, Colorectal, Ovarian Carcinomas. (3) Less frequent cancers are not studied as soon as registration is obtained in one major indication therefore accounting for wide off-label prescriptions. A process allowing for alteration of the SPC on the basis of well conducted Institutional trials should be considered together with appropriate cost adjustments. (4) Pharmacovigilance of antineoplastic agents is almost non existent. (5) Further trials addressing dose-intensity as well as atypical combinations (i.e double alkylation) are examples of non approved procedures which ultimately might legally involve Oncologists. As Registration can be acquired early, and further use of the agent can be looked without modification of the SPC, one can expect than Social Security and/or Insurances will limit the use of recently approved agents to the legal indications. It is thus the responsibility of the Oncology Community to (1) Participate in prospective trials; (2) organize consensus conference to define the State of the Art in the use of anticancer agents.