CONCEPTIONAL AND STRUCTURAL CONDITIONS FOR SUCCESSFUL CLINICAL RESEARCH

The efficiency of surgical research has again become the subject of de bate. Clinical research is required to improve our understanding of su rgical disorders and our ability to treat patients. This involves both experimental research (research in the test tube) and clinical resear ch in actual patients. The surgeon must remain the expert because it i s he who deals with the patient and is confronted with his problems. O n the other hand, care for the patient, must always be the central iss ue. Here a new orientation is needed, evaluating the effectiveness of surgical research from the patient's point of view. Surgical treatment , particularly surgical research, must be adapted first to the individ ual patient and only secondly to the surgical disease - the problem mu st determine the method, not vice versa. While it is clear that a crea tive atmosphere, supportive structure and efficient organisation are e normously helpful, today's exaggerated attention to matters of structu re and organisation are often poor substitutes for creativity and intu ition. Surgical research does not refer solely to therapy research but includes methods for carrying out controlled clinical trials, establi shing guidelines and scores and designing instruments for measuring ou tcome. Socioeconomic and analyses and ethical considerations are cruci al for facing such conflicts as ''quality versus quantity'', ''profess ion versus business'', ''patient care versus economics costs''. Propos als for designing more effective concepts, structure and organisation for clinical research are presented here, and three models are introdu ced: the cooperation model, the integration model and a mixture of the two.