A bibliometric analysis of the clinical development of drugs in Norway for the year 2000.

PURPOSE: Bibliometric analysis of publications was used to investigate the research output relating to the development of drugs in Norway and to evaluate the impact of Norwegian involvement in this research. MATERIAL AND METHODS: One hundred and nine articles published between 2002 and 2008 were analysed. Bibliometric methods used were as follows: information on peer review, impact factor (IF), the Science Citation Index (SCI) and the representation of Norwegians in the list of authors. RESULTS: All publications were in journals with peer review or in publications with corresponding evaluation. Industrial support, international research cooperation and drug development in phases I, II and III seem to promote publication in journals with high IF and a high SCI. In 63% of the international project articles, the Norwegian contributors were not represented in the list of authors. CONCLUSION: In addition to a scientific standard secured by referees, three probably independent factors - industrial support, international cooperation and early phases of the research (phases I, II and III) - seem to promote publications in journals with high IF and a high SCI. A more active Norwegian contribution to the research should be encouraged.

An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results.

OBJECTIVE: In Norway, very little data are available on the relation between the total number of research projects on the clinical development of drugs that have been started, the number of these projects in which the research phase has been completed and the number of projects for which results have been published. The aim of this study was to determine the number of projects in which the research phase had been completed and the results published. MATERIAL AND METHODS: Information on research projects carried out on the clinical development of drugs during the year 2000 was obtained from the archives of the Norwegian Research Ethical Committee (REC) and subsequently analysed. RESULTS: The final analysis revealed that 245 research projects on the clinical development of drugs had been started in 2000. Of these, 178 (73%) completed the research phase as planned. The results of 131 (54%) of these projects were published in a scientific journal, and another 34 (14%) were reported as a congress abstract or as report to a sponsor; 80 (33%) were not published at all. Industrial sponsors seemed to promote both the completion of the research process and the publication of results in scientific journals.

An analysis of the clinical development of drugs in Norway for the years 2000 and 2004: the influence of the pharmaceutical industry.

OBJECTIVE: Little has been published either concerning the total number of research projects in connection with clinical development of drugs or the number of projects financially supported by the industry. METHODS: From the archives of the five regional Norwegian Research Ethical Committees (REC), all research projects in connection with clinical development of drugs for the years 2000 and 2004 were analysed with the intention of finding the number of projects financially supported by the industry, the type of research institution, the industrial company, the topic of the research as classified in the international Anatomic Therapeutic Classification system (ATC), the research phase and the approval status of the drug by the Norwegian Medicines Agency (NMA). RESULTS: The total number of research projects for the clinical development of drugs for the years 2000 and 2004 was 489, and 75.7% were financially supported by the industry. More than two-thirds of the projects were done in academic institutions and about one-third were equally divided between public health hospitals and private health service/hospitals. Eight of the 88 drug companies involved were among the world's largest and supported 38% of the projects. Fifty-nine percent of all the projects were within four therapeutic groups: antineoplastic/immunomodulating agents, nervous system, cardiovascular system and alimentary tract/metabolism. The distribution of research phases was as follows: phase I 1.2%, phase II 16.4%, phase III 26.6% and phase IV 55.8%. In the phase IV drug trials, drugs had been approved for sale by the NMA. CONCLUSIONS: The share of research projects related to the development of drugs supported by the industry is high. Research independent of the industry is of importance to avoid bias and selective publications and to prevent research as a means of marketing. Independent research should be encouraged and financially supported by sources with no connection to the drug industry.

Late radiation effects on hearing, vestibular function, and taste in brain tumor patients.

PURPOSE: To investigate late radiation effects on hearing, vestibular function, and taste after conventional radiotherapy in brain tumor patients. METHODS AND MATERIALS: Hearing, vestibular function, and taste were assessed in 33 brain tumor patients irradiated unilaterally to the tumor-bearing hemisphere and the temporal bone. Median observation time after completion of radiotherapy was 13 years; the fraction dose was 1.8 Gy, and mean radiation dose was 53.1 Gy. RESULTS: Deep ulceration in the external ear canal and osteoradionecrosis on the irradiated side was seen in three patients. Reduced hearing was found for air and bone conduction of the irradiated side compared to the opposite side (0.25-2 kHz: 6.1 dB, 4 kHz: 10.3 dB, 6 kHz: 15.6 dB, and 8 kHz: 16.5 dB). For bone conduction, the corresponding figures were 0.25-2 kHz: 5.5 dB and 4 kHz: 8.2 dB. Three patients had a canal paresis of the irradiated side, and three patients had affection of the chorda tympani. CONCLUSION: Irradiation of the temporal bone with doses usually given in the treatment of patients with brain tumors may cause osteoradionecrosis, sensorineural hearing loss, dysfunction of the vestibular inner ear, and loss of taste. Head-and-neck examination should be included in the follow-up of long-term survivors.