A Decade On: Systematic Review of ClinicalTrials.gov Infectious Disease Trials, 2007–2017

Abstract

Background 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. Methods 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. Results 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. Conclusions 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.

The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days

“…The emergence of 683 trials in a 100-day period is unparalleled. Between 250 to 342 HIV/AIDS trials are registered per year on ClinicalTrials.gov 18 and only three were registered for Middle East respiratory syndrome (MERS) coronavirus during 2007-2017 18 . While efforts being put into clinical trials were initially welcome, the vast majority of COVID-19 trials are at risk of being abandoned if they cannot recruit enough patients or if other trials on the same treatment provide conclusive results (favorable or unfavorable).…”

The landscape of investigator‐initiated oncology trials conducted in mainland China during the past decade (2010–2019)

“…It is well established that the first step to achieve reliable results in clinical studies lies in the design of the study. Serving as one of the largest registries of clinical trials and a useful tool to understand the clinical trial landscape, several analyses of registrations in CT.gov have been published, including in the fields of oncology [ 21 , 22 , 23 ], psychiatry [ 24 ], ophthalmology [ 25 ], infectious disease [ 26 ], and COVID‐19 [ 27 ]. In the present study, we integrated the phase, enrollment, randomization, and masking of cancer‐related IITs from the two registration websites and identified 3898 studies in phase 1 to phase 4, with phase 2 accounting for the majority (39.0%, 1521/3898), similar to the results of an analysis of Japanese IITs [ 11 ].…”

The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days

“…The emergence of 689 trials in a 100-day period is unparalleled. Between 250 to 342 HIV/AIDS trials are registered per year on ClinicalTrials.gov 18 and only three were registered for Middle East respiratory syndrome (MERS) coronavirus during 2007–2017 18 . While efforts being put into clinical trials were initially welcome, the vast majority of COVID-19 trials are at risk of being abandoned if they cannot recruit enough patients or if other trials on the same treatment provide conclusive results (favorable or unfavorable).…”