Related Experiment Video
Updated: Jun 25, 2026
Histological Quantification to Determine Lung Fungal Burden in Experimental Aspergillosis
Published on: March 9, 2018
Clinical trial design for invasive aspergillosis: time to cast a different mold
Marisa Miceli1, Elias Anaissie
1Division of Infectious Diseases, University of New Mexico Health Science Center, Albuquerque, New Mexico, USA.
Abstract:
Despite the availability of active antifungal agents, invasive aspergillosis (IA) continues to be a significant cause of morbidity, mortality, and resource utilization among the various patient populations at risk. New and more effective therapies are required. Like with other drugs, the regulatory approval of new mold-active agents is based on the results of randomized clinical trials (RCT) which are particularly difficult to conduct and usually take several years to complete at very high costs. The limitations of conventional RCTs for aspergillus-active agents are discussed and novel trial methodologies that are likely to expedite approval of therapies active against aspergillosis are proposed.
Insights
Invasive aspergillosis (IA) remains a serious threat, necessitating novel therapies. This study discusses limitations of current clinical trials for antifungal drugs and proposes new methods to speed up regulatory approval.
Area of Science:
- Mycology
- Infectious Diseases
- Clinical Trial Design
Background:
- Invasive aspergillosis (IA) presents a significant clinical challenge, leading to high morbidity and mortality despite existing antifungal treatments.
- Developing new antifungal therapies is crucial for managing IA in at-risk patient populations.
- Regulatory approval for new antifungal agents relies on randomized clinical trials (RCTs), which are costly and time-consuming.
Purpose of the Study:
- To discuss the limitations inherent in conventional randomized clinical trials (RCTs) for evaluating aspergillus-active agents.
- To propose novel clinical trial methodologies that could accelerate the approval process for new therapies targeting IA.
Main Methods:
- Critical analysis of the challenges and drawbacks associated with traditional RCTs in the context of IA drug development.
- Exploration and conceptualization of alternative or modified trial designs suitable for antifungal agents.
Main Results:
- Conventional RCTs for IA therapies are identified as resource-intensive, lengthy, and difficult to execute.
- The limitations hinder the timely availability of potentially life-saving treatments for patients with IA.
Conclusions:
- Existing RCT frameworks pose significant barriers to the efficient development and approval of new antifungal drugs for IA.
- Adoption of innovative trial methodologies is essential to expedite the delivery of effective therapies to patients battling invasive aspergillosis.
