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06/04/2018

Commercial clinical trials are registered and published more than non-commercial ones

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06/04/2018

A retrospective study points out the differences between the trials promoted by the pharmaceutical industry and those that are not.

The Clinical Pharmacology Service of Vall d'Hebron together with the Vall d'Hebron Research Institute (VHIR) have carried out an observational retrospective study that has allowed us to demonstrate that commercial clinical trials are registered and published more than academic or non-commercial trials. The study has been published in the journal https://bpspubs.onlinelibrary.wiley.com/doi/abs/10.1111/bcp.13555 British Journal of Clinical Pharmacology.The aim of the study was to analyse some design features, the public register of clinical trials and the publication rate of non-commercial clinical trials and to compare them with those of clinical trials sponsored by the pharmaceutical industry.A total of 809 applications for clinical trials with drugs were submitted between May 2004 and May 2009 to the Research Ethics Committee of the Vall d'Hebron University Hospital. Of these, 778 received positive feedback to be carried out. 83.7% were commercial (651) and 16.3% were non-commercial (127).This proportion of non-commercial clinical trials found in the study (16%) was similar to that previously reported in Spain and Germany but lower than in other countries such as the United Kingdom, the Netherlands, Denmark, Italy and France, where the percentage described was over 25%.Non-commercial trials are those that are sponsored by an academic or hospital institution, a scientific society, or clinical researchers. The study found that these were mainly phase IV, multicentre, national, controlled and open (unblinded) trials.Commercial trials, i.e. those sponsored or supported by the pharmaceutical industry, were mainly phase II-III, multicentre, international and double-blind. Therefore, with a more complex design than non-commercial trials.ConclusionsThe study came to three main conclusions. First, that commercial trials were entered into public registries (such as ClinicalTrials.gov) and published in scientific journals more frequently than non-commercial ones. In addition, "information regarding follow-up and trial status was also updated more frequently in commercial trials than in academic trials", said Dr. Inmaculada Fuentes, study coordinator.The second conclusion is that the results of research, commercial or non-commercial, should be disseminated so as not to compromise their scientific or social value. In the opinion of Dr. Fuentes, "it is essential that regardless of whether the clinical trials are commercial or non-commercial, and whether the results are positive or negative, they are made publicly available". Therefore, in 2004, the International Committee of Medical Journal Editors established that before starting patient recruitment, clinical trials must be registered. This must also be a condition for their publication in biomedical journals. In addition, new European legislation requires publication of results in public databases. The public ClinicalTrials.gov and EU Clinical Trials Register (EU-CTR) provide an opportunity to make the results accessible to the scientific community. The study observed a low percentage of published trial results (44.5%), especially for non-commercial trials (only one was reported), and this is a major problem to be solved. The third conclusion is that more funding is still needed. The information generated by clinical trials is essential, not only for the approval of new drugs but also to establish treatment guidelines for diseases and to help define health policies. Sometimes the needs of clinical practice do not coincide with the interests of the industry, and clinical researchers, especially those in non-commercial studies, must make a greater effort to disseminate the results of their research. Therefore, "it is necessary to support independent clinical research aimed at resolving the issues raised by clinical practice," says Fuentes. Initiatives such as the European Clinical Research Infrastructure Network (ECRIN) and funding from European funds such as Horizon2020 could be good opportunities for non-commercial research.

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