To investigate how drug trials are carried out and reported in Norway and to what extent they are published.
All drug trials notified in 1996 were included in the study. Data were obtained from the standard notification form, correspondence with investigators, end-of-study reports, and a questionnaire designed for this study.
A total of 208 drug trials were notified. Most trials were initiated by the pharmaceutical industry (85%) and international multicenter studies constituted a major part (73%). Mandatory end-of-study reports were submitted to the health authorities on 48 (23%) of the trials. Out of a total of 159 trials for which we have data, 39 (25%) were interrupted or not started. Out of a total of 143 trials for which we have data on publishing, 77 (54%) were not published. Trials with a positive conclusion (54%) were more likely to be published than those with a negative conclusion (38%).
The reporting of drug trials is not satisfactory. Because of low reporting frequency, health authorities do not obtain a comprehensive overview. The pharmaceutical industry initiates the majority of the trials and clinical researchers in Norway increasingly participate in international multicentre trials. Many trials are not carried out as planned; less than half are published.
Federal Research Institute for Health Organization and Informatics of Ministry of Health of the Russia, Moscow, Russia; Center for Scientific and Technical Expertise, Institute of Applied Economic Research, The Russian Presidential Academy of National Economy and Public Administration, Moscow, Russia.
During 2012-2018 in the Russian Federation, pursuant to Presidential Decree No. 599 of 05.07.2012, a set of state support measures was implemented aimed at increasing the specific gravity of Russian publications indexed in international databases. The national project 'Science' (NPS) designed to realize the goals set by Presidential Decree No.204 of 05.07.2018 'On the National Goals and Strategic Tasks for Development of the Russian Federation until 2024' continues and develops the theme of increasing the publication activity of the Russian Federation in the internationalized space. One of the six NPS targets is 'The place of the Russian Federation in terms of specific gravity in the total number of articles in areas defined by the priorities of scientific and technological development in publications indexed in international databases'. The purpose of this study was to evaluate the basic value of this indicator for biomedical disciplines related to the priority direction (paragraph 20c) of the Strategy for Scientific and Technological Development of the Russian Federation. We compared volumes of publication flows of the Russian Federation in 20 biomedical disciplines with a similar indicator of countries ranked fifth in the number of publications on the subject area under consideration, indexed in the Web of Science Core Collection (WoS CC). A 5-10 fold lag of the Russian Federation was recorded for the most part of the priority areas in the field of biomedicine identified by the NTS passport. The impact of public policy measures aimed at increasing the national biomedical publication stream for the period of 2012-2018 was estimated as insufficient to meet the considered NTS target.
A quarter of a century ago ethics was an esoteric term, known to theologians and philosophers, but unknown as a discipline to the majority of doctors. Since then, however, ethics has become a substantial part of clinical medicine and health research. Ethics as an area of interest for Danish gastroenterologists appeared from several foci in the early days. One angle was an almost revival-like interest in research methodology and its ethical dimensions. Other angles were derived from Danish gastroenterologists' experiences transferred from other disciplines before the birth of Danish gastroenterology. From the time of these early incentives Danish gastroenterologists have constituted a platform for the implementation of the basic principles, lying behind medical ethics, now in collaboration with other parts of the medical profession. The topics are reflected in a number of publications and in the various practical diversions. An interest in information of patients appeared at an early stage. Publication ethics as a subdiscipline involved Danish gastroenterologists and has led to contributions within the framework of the International Group of Medical Journal Editors. Research ethics, a central topic throughout all years, has led to such important initiatives as the Second Helsinki Declaration and the establishment of a national control system for medical research in man. A further ramification of ethics is scientific dishonesty and good clinical practice. Here a recent initiative has led to the establishment of a national Committee on Scientific Dishonesty. Under the auspices of the OMGE (Organisation Mondiale de Gastroentérologie) Danish gastroenterologists have investigated transnational and transcultural differences in gastroenterologists' attitudes to information of patients and relatives and have unmasked considerable and important differences throughout the world. Medical ethics has, together with scientific methodology, to some extent reunited the sub-specialized fragments of the mother disciplines medicine and surgery and in this way has acted as partes pro toto.
The policy implications of a 1996 national nursing survey on the allocation of publication credit form of this paper. An earlier article (Butler & Ginn, 1997) describes and analyzes the outcome of the survey; the purpose here is to draw on that analysis, and on the relevant literature, to propose a starting place for discussion within the specialty of oncology and the nursing profession regarding assignment of credit for various contributions to collaborative scholarly work. After identifying the growing need for such a discussion and briefly highlighting the findings of the survey, the paper goes on to examine unacceptable practices in scholarly work and identify issues which should be resolved before collaborative work is undertaken. The final portion of the paper makes tentative suggestions as to principles and guidelines which might be applied to avoid disputes about the value of different contributions to a collaborative project. It is emphasized that the intention is not to advocate acceptance of the guidelines suggested here, but to create sufficient interest so that an approach to allocation of publication credit may be developed which will be consistent and relevant to the needs of the nursing profession.
