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Multicentre clinical trials: Is practice of authorship in place fair?
- Sergei Tjulandin, Anatoly Makhson, Vladimir MoiseyenkoC (21 September 2006)
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Sergei Tjulandin, Deputy Director (Clinical Research), Institute of Clinical Oncology N.N. Blokhin Russian Cancer Research Center, Moscow 115478 Russia, Anatoly Makhson, Vladimir MoiseyenkoC
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Moscow, 20 September 2006 Dear Sir, We would like to draw your attention to the article of M. Green et al. “Abraxane, a novel cremophor-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer” which was published recently in your journal. The article is focused on the results of a study performed in some Cancer Clinics in the Russian Federation. The sponsor of the study was American BioScience Inc (USA). A renowned specialist dealing with non-small cell lung cancer, Dr. M. Green, is the first author in this article. This is an indication of the present unfair practice in place, when results of studies conducted in Russian Federation, Ukraine and other countries that are not considered to be leaders in contemporary oncology are published with the authorship of some leading western oncologists. This particular article may not be the best example as there are still some Russian authors mentioned. There are lots of other studies which were conducted mostly in Russia or Ukraine and the articles either did not have a single author or had utmost one author from the respective country. What makes the sponsoring companies to follow this mechanism of “identifying suitable authors”? First of all, it is their marketing strategy. The investigational drug is primarily pushed up in the United States pharmaceutical market. That is why the “leadership” of western authors gives an academic touch and prestige that in turn convinces the readers. Moreover, as a rule, the western authors included in the publication are expected to present the respective drug at various meetings. The sponsors are hiding the fact that a given study is conducted in Russia by reducing or removing the representation of Russian authors in the publications. It has to be noted that many FDA inspections and company audits that were conducted have totally ruled-out any distrust in Russian oncologists and the results obtained by them. Of course, the Russian specialists are to be blamed for the lack of communication skills and knowledge in English that would enable them to interact freely and present their data at international meetings. This letter is not aimed at criticizing Dr. M. Green or other “first authors” like him. As we all know, any clinical trial conducted is strictly controlled by the regulations of GCP, starting from the very idea of the trial, methodology of patient selection and treatment, till the analysis of the results. Special interest is given to the ethical aspects and the interests & rights of the patients who take part in the trial. On the other hand, there is no regulation at all that would defend the rights of the investigators including the publication of results. In the case of multicentre industry-sponsored trial the sponsoring company decides the group of authors who will be included in any publication concerning the results of a given trial on the basis of the company’s interests. It is high time that the scientific community and especially, the editors of scientific periodicals should take interest in formulating recommendations that would defend the interests of the investigators depending on their contribution and would rule-out the discrimination towards separate authors on the basis of their domicile, knowledge of English language etc. In course of time such recommendations may very well become part of GCP. Thanking you, Yours sincerely, Prof. Sergei A. Tjulandin, Deputy Director (Clinical Research), Institute of Clinical Oncology, N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation Prof. Anatoly Makhson, Chief Physician, Moscow City Oncological Hospital #62, Moscow, Russian Federation Prof. Vladimir Moiseyenko, Director, N.N. Petrov Research Institute of Oncology, St. Petersburg, Russian Federation Conflict of Interest:None declared |
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