Cochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary.
Doctoral School of Clinical Neurosciences, Medical School, University of Pécs, Pécs, Hungary.
Trials. 2022 Apr 21;23(1):330. doi: 10.1186/s13063-022-06268-y.
Clinical research should provide reliable evidence to clinicians, health policy makers, and researchers. The reliability of evidence will be assured once study planning, conducting, and reporting of results are transparent. The present research investigates publication rates, time until publication, and characteristics of clinical trials on medicinal products associated with timely publication of results, measures of scientific impact, authorship, and open access publication.
Clinical trials authorized in Hungary in 2012 were followed until publication and/or June 2020. Corresponding scientific publications were searched via clinical trial registries, PubMed (MEDLINE), and Google.
Overall, 330 clinical trials were authorized in 2012 of which 232 trials were completed for more than 1 year in June 2020. The proportion of industry initiation was high (97%). Time to publication was 21 (22) months [median (IQR)]. Time to publication was significantly shorter when trials involved both European and non-European countries (26 vs 69 months [median]; hazard ratio = 0.38, 95% CI 0.22-0.66, p< 0.001), and were registered in both EU CTR and clinicaltrials.gov (27 vs 88 months; hazard ratio = 0.24, 95% CI 0.11-0.54; p< 0.001) based on survival analyses. A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register. The majority of available publications were published "open access" (70.93%). A minority of identified publications had a Hungarian author (21.5%).
We encourage academic researchers to plan, register and conduct trials on medicinal products. Registries should be considered as an important source of information of clinical trial results. Publications with domestic co-authors contribute to the research output of a country. Measurable domestic scientific impact of trials on medicinal products needs further improvement.
临床研究应向临床医生、卫生政策制定者和研究人员提供可靠的证据。一旦研究计划、进行和报告结果透明，证据的可靠性将得到保证。本研究调查了与及时公布结果、科学影响衡量标准、作者署名和开放获取出版相关的药品临床试验的发表率、发表时间和特征。
对 2012 年在匈牙利获得授权的临床试验进行随访，直至发表或 2020 年 6 月。通过临床试验注册机构、PubMed（MEDLINE）和 Google 搜索相应的科学出版物。
2012 年共授权 330 项临床试验，其中 232 项试验在 2020 年 6 月完成，持续时间超过 1 年。工业发起的比例很高（97%）。发表时间为 21（22）个月[中位数（IQR）]。当试验涉及欧洲和非欧洲国家时，发表时间明显缩短（26 与 69 个月[中位数]；风险比=0.38，95%置信区间 0.22-0.66，p<0.001），并且在欧盟 CTR 和 clinicaltrials.gov 都有登记（27 与 88 个月；风险比=0.24，95%置信区间 0.11-0.54；p<0.001），这是基于生存分析的结果。在试验登记处可获得大量（24.1%）未发表的临床试验结果。可获得的大部分出版物均为“开放获取”（70.93%）。已确定出版物中只有少数有匈牙利作者（21.5%）。
我们鼓励学术研究人员对药品进行计划、登记和进行临床试验。登记处应被视为临床试验结果的重要信息来源。有国内共同作者的出版物有助于一个国家的研究产出。需要进一步提高药品临床试验的国内可衡量科学影响力。
