TY - JOUR
T1 - Characteristics of antimicrobial studies registered in the USA through ClinicalTrials.Gov
AU - Stockmann, Chris
AU - Sherwin, Catherine M.T.
AU - Ampofo, Krow
AU - Hersh, Adam L.
AU - Pavia, Andrew T.
AU - Byington, Carrie L.
AU - Ward, Robert M.
AU - Spigarelli, Michael G.
N1 - Funding Information:
More than 16 000 antimicrobial studies have been registered in ClinicalTrials.gov since 2000. Collectively, evaluation of antimicrobial agents accounts for nearly 1 in 10 of all registered clinical research studies. The vast majority were interventional trials of drugs and biologics. Primary endpoints frequently included markers of safety and efficacy. Nearly 75% of interventional drug trials were randomised and 26% recruited children in addition to adults. Funding for antimicrobial studies varied, with 60% of studies primarily sponsored by non-profit organisations, 30% from industry and 10% from the federal government. Across all completed interventional drug trials, only 12% have been updated with study results and/or publications and, notably, the vast majority of the studies with results available were sponsored primarily by industry sources.
PY - 2013/8
Y1 - 2013/8
N2 - Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come.
AB - Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come.
KW - Anti-infective agents
KW - Antibacterial
KW - Antibiotic
KW - Antifungal
KW - Antiviral
UR - http://www.scopus.com/inward/record.url?scp=84880294301&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84880294301&partnerID=8YFLogxK
U2 - 10.1016/j.ijantimicag.2013.04.019
DO - 10.1016/j.ijantimicag.2013.04.019
M3 - Article
C2 - 23726436
AN - SCOPUS:84880294301
SN - 0924-8579
VL - 42
SP - 161
EP - 166
JO - International Journal of Antimicrobial Agents
JF - International Journal of Antimicrobial Agents
IS - 2
ER -