Jaffe Ian S, Chiswell Karen, Tsalik Ephraim L
Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine.
Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Open Forum Infect Dis. 2019 Apr 15;6(6):ofz189. doi: 10.1093/ofid/ofz189. eCollection 2019 Jun.
Registration of interventional trials of Food and Drug Administration-regulated drug and biological products and devices became a legal requirement in 2007; the vast majority of these trials are registered in ClinicalTrials.gov. An analysis of ClinicalTrials.gov offers an opportunity to define the clinical research landscape; here we analyze 10 years of infectious disease (ID) clinical trial research.
Beginning with 166 415 interventional trials registered in ClinicalTrials.gov from 2007-2017, ID trials were selected by study conditions and interventions. Relevance to ID was confirmed through manual review, resulting in 13 707 ID trials and 152 708 non-ID trials.
ID-related trials represented 6.9%-9.9% of all trials with no significant trend over time. ID trials tended to be more focused on treatment and prevention, with a focus on testing drugs, biologics, and vaccines. ID trials tended to be large, randomized, and nonblinded with a greater degree of international enrollment. Industry was the primary funding source for 45.2% of ID trials. Compared with the global burden of disease, human immunodeficiency virus/AIDS and hepatitis C trials were overrepresented, and lower respiratory tract infection trials were underrepresented. Hepatitis C trials fluctuated, keeping with a wave of new drug development. Influenza vaccine trials peaked during the 2009 H1N1 swine influenza outbreak.
This study presents the most comprehensive characterization of ID clinical trials over the past decade. These results help define how clinical research aligns with clinical need. Temporal trends reflect changes in disease epidemiology and the impact of scientific discovery and market forces. Periodic review of ID clinical trials can help identify gaps and serve as a mechanism to realign resources.
对食品药品监督管理局监管的药物、生物制品和器械进行的干预性试验注册在2007年成为一项法律要求；这些试验绝大多数在ClinicalTrials.gov上注册。对ClinicalTrials.gov进行分析为界定临床研究格局提供了契机；在此我们分析了10年的传染病（ID）临床试验研究。
从2007年至2017年在ClinicalTrials.gov上注册的166415项干预性试验开始，根据研究条件和干预措施选择ID试验。通过人工审核确认与ID的相关性，最终得到13707项ID试验和152708项非ID试验。
与ID相关的试验占所有试验的6.9% - 9.9%，且随时间无显著趋势。ID试验往往更侧重于治疗和预防，重点是测试药物、生物制品和疫苗。ID试验往往规模较大、采用随机分组且不设盲，国际参与度更高。行业是45.2%的ID试验的主要资金来源。与全球疾病负担相比，人类免疫缺陷病毒/艾滋病和丙型肝炎试验的占比过高，而下呼吸道感染试验的占比过低。丙型肝炎试验有波动，与一波新药研发浪潮相符。流感疫苗试验在2009年甲型H1N1流感大流行期间达到峰值。
本研究呈现了过去十年ID临床试验最全面的特征。这些结果有助于明确临床研究如何与临床需求相匹配。时间趋势反映了疾病流行病学的变化以及科学发现和市场力量的影响。对ID临床试验进行定期审查有助于发现差距，并作为重新调整资源的一种机制。
