ABSTRACT
Title
Dissemination of clinical trial results through clinical trial registers.
Authors
M. Vietri, S. Benemei, C. Lupi, A. Xheka, P.Geppetti, A.Mugelli
Department of Preclinical and Clinical Pharmacology - University of Florence
Department of Preclinical and Clinical Pharmacology - University of Florence
Abstract
Only when published, results of clinical trials are relevant for clinical decision-making. If clinical trial results are not published or reported selectively, a distortion of effect or harm of treatments can occur. It has been recognized that many clinical trials are not published after completion of data collection and analysis. In order to increase transparency in clinical trials and to promote dissemination of clinical-research results, public registration of clinical trials has been introduced. Since 2004 the Italian Medicines Agency (AIFA) forced commercial and non commercial sponsors to register relevant information about clinical trials with medicines conducted in Italy in the National Monitoring Centre on Clinical Trials with Medicines (Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali, hereafter OsSC). The OsSC allows clinical trial sponsors to include a summary of the results andor published reports of clinical trials that have been registered and concluded. To the best of our knowledge, there has been no systematic analysis of clinical trial results included in OsSC.
The objective of our survey was to assess the publication rate of clinical trials submitted to the research ethics committee of University Hospital of Careggi (Florence, Italy) from January 1998 to December 2007. A total of 718 research protocols were retrieved. According to the information reported in the OsSC database, 547 clinical trials were concluded by December 31st, 2007: 300 (54%) did not include any results, 162 (30%) included a summary of the results, 69 (13%) had both a summary of the results and a bibliographic reference to a publication, 11 (2%) included only the bibliographic reference and 5 (1%) the downloadable publication. Therefore, only for 85 clinical trials (16%) a bibliographic reference or a downloadable published article was available. We also searched on the ClinicalTrials.gov registry for bibliographic references. Only 251 (46%) of the 547 clinical trials recorded in OsSC were registered in ClinicalTrials.gov and for 81 (out of 251) of them (32%) bibliographic references were available. For 20 clinical trials the bibliographic references were included both in OsSC and ClinicalTrials.gov.
Our research shows that both OsSC and ClinicalTrials.gov provide bibliographic reference or downloadable published articlefor not more than 16% of the 547 clinical trials searched.Although clinical trials registers represent an important step through clinical trials transparency, up to date they fail to provide full information about clinical trials results. Investigators, research ethics committees, funding bodies, and scientific editors all have the responsibility to reduce underreporting of clinical trials results. If data arising from clinical studies are not publicly available, an important ethical requirement is not fulfilled. Research ethics committees should dedicate temporal and financial resources to monitoring whether results of approved clinical trials are published.
De Angelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363-1364.
Zarin D, Tse T, Williams R, et al.The ClinicalTrials.gov Results Database — Update and Key Issues. N Engl J Med 2011;364:852-60.
The objective of our survey was to assess the publication rate of clinical trials submitted to the research ethics committee of University Hospital of Careggi (Florence, Italy) from January 1998 to December 2007. A total of 718 research protocols were retrieved. According to the information reported in the OsSC database, 547 clinical trials were concluded by December 31st, 2007: 300 (54%) did not include any results, 162 (30%) included a summary of the results, 69 (13%) had both a summary of the results and a bibliographic reference to a publication, 11 (2%) included only the bibliographic reference and 5 (1%) the downloadable publication. Therefore, only for 85 clinical trials (16%) a bibliographic reference or a downloadable published article was available. We also searched on the ClinicalTrials.gov registry for bibliographic references. Only 251 (46%) of the 547 clinical trials recorded in OsSC were registered in ClinicalTrials.gov and for 81 (out of 251) of them (32%) bibliographic references were available. For 20 clinical trials the bibliographic references were included both in OsSC and ClinicalTrials.gov.
Our research shows that both OsSC and ClinicalTrials.gov provide bibliographic reference or downloadable published articlefor not more than 16% of the 547 clinical trials searched.Although clinical trials registers represent an important step through clinical trials transparency, up to date they fail to provide full information about clinical trials results. Investigators, research ethics committees, funding bodies, and scientific editors all have the responsibility to reduce underreporting of clinical trials results. If data arising from clinical studies are not publicly available, an important ethical requirement is not fulfilled. Research ethics committees should dedicate temporal and financial resources to monitoring whether results of approved clinical trials are published.
De Angelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363-1364.
Zarin D, Tse T, Williams R, et al.The ClinicalTrials.gov Results Database — Update and Key Issues. N Engl J Med 2011;364:852-60.