Differing attitudes of industry and academia towards controlled clinical trials

A consensus conference was held in 1984 on controversial issues concerning controlled clinical trials. Thirty-six individuals working in academic institutions, forty-six in industry and twelve in regulatory authorities participated. Academics accepted and industrial representatives rejected the following: existing regulations cannot cope with the rate at which new treatments develop; drug companies may be reluctant to undertake surveillance programmes because sales will fall if adverse reactions are detected; novel remedies should not be promoted before extensive post-marketing surveillance; third parties should finance trials promising to reduce the costs of illness and trialists should be separated from sponsors in data analysis and interpretation, the investigator owning the data unless stated otherwise. Industrial representatives supported and academics rejected the following: government price control inhibits drug development and a multicentre trial can be justified simply by the wish to speed drug registration.     

Resection of hepatocellular carcinoma: Oligocentric origin of recurrent and multinodular tumours

The structure of integrated hepatitis B virus (HBV) DNA was analysed to determine the origin of recurrent and multinodular hepatocellular carcinoma (HCC). In 5 cases, recurrent tumours were compared with the respective primary tumours, all of which had chromosomally integrated viral DNA. In only one of these cases, an identical HBV DNA integration pattern was found, indicating a monocentric origin of primary and secondary tumour. In all other cases a polycentric origin was deduced. Particular features observed were: (i) the apparent absence of integrated viral DNA in a recurrent tumour; and (ii) an integration pattern identical to that of the primary tumour and a distinct new pattern in two different foci of multinodular recurrent HCC. For multinodular primary HCC one case was analysed and found to be of independent origin.