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Clinical trials and novel pathogens: lessons learned from SARS
Matthew P Muller1, Allison McGeer, Sharon E Straus
1Mount Sinai Hospital, Toronto, Ontario, Canada.
Emerging Infectious Diseases
|April 28, 2004
Summary
Conducting clinical trials during infectious disease outbreaks like SARS is challenging. Controlled studies are crucial for effective treatment decisions in future epidemics, yet often lack data.
Area of Science:
- Infectious Diseases
- Clinical Trials
- Epidemiology
Background:
- During the SARS outbreak, treatments like ribavirin and corticosteroids were used despite uncertain efficacy and known toxicity.
- No controlled clinical trials were conducted to assess these treatments during the SARS outbreak.
- This lack of data hinders therapeutic decisions in potential future outbreaks.
Purpose of the Study:
- To discuss the challenges of conducting controlled therapeutic trials during novel infectious pathogen outbreaks.
- To share lessons learned from attempting a randomized controlled trial for SARS.
- To propose strategies for facilitating future outbreak clinical trials.
Main Methods:
- Discussion of methodologic and logistical challenges in outbreak research.
- Retrospective analysis of experiences conducting a randomized controlled trial for SARS.
- Identification of strategies to improve future outbreak trial implementation.
Main Results:
- Controlled clinical trials for novel pathogen treatments are difficult to execute during outbreaks.
- Experience highlighted significant logistical and methodological hurdles.
- Specific strategies can improve the feasibility of future outbreak trials.
Conclusions:
- Controlled trials are essential for evidence-based treatment during epidemics.
- Proactive planning and adaptive strategies are needed to overcome outbreak research challenges.
- Facilitating rapid, rigorous clinical trials is critical for global health security.