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Clinical trials: types, design, and end-points.

¹University of Medicine and Dentistry of New Jersey-Scleroderma Program, New Brunswick, New Jersey 08903-0019, USA. seiboljr@umdnj.edu

Current Opinion in Rheumatology

|November 8, 2001

Summary

Systemic sclerosis research is advancing with new clinical trials and improved survival rates. However, the complex nature of this disease means single-target therapies may not address all its features.

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Area of Science:

Rheumatology
Immunology
Clinical Research

Background:

Systemic sclerosis pathogenesis remains poorly understood.
Clinical research trials are increasingly focused on modifying disease outcomes.
Survival rates have improved, primarily due to organ-specific therapies.

Purpose of the Study:

To review the evolution of clinical trial design in systemic sclerosis.
To assess the impact of current therapeutic strategies.
To discuss the challenges in developing comprehensive treatment approaches.

Main Methods:

Review of high-quality clinical research trials in systemic sclerosis.
Analysis of candidate outcome measures and trial design templates.
Evaluation of therapeutic strategies targeting single organs.

Main Results:

Survival in systemic sclerosis has improved through organ-focused therapies.
Candidate outcome measures have been evaluated.
A consensus template for trial design has emerged.

Conclusions:

The complexity of systemic sclerosis suggests that single-mechanism therapies are unlikely to resolve all disease manifestations.
Future research may require broader therapeutic strategies.
Continued development in clinical trial design is essential for systemic sclerosis research.

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