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5 Considerations for Conducting Clinical Trials within a Critical Care Environment

In this article, we discuss key considerations for conducting a successful clinical trial within critical care. Critical care trials are complex and fast-paced, typically with high mortality rates, high patient diversity, and unpredictability. Clinical research in the critical care setting also involves numerous ethical and regulatory requirements, especially as severely ill patients may be unable to consent.

Contents:

• Introduction
• Evaluating key processes
• Characteristics of a qualified CRA
• Training to mitigate risk of misdiagnosis
• Informed Consent and LARs
• Relationships with PIs

Evaluating Site Processes During Feasibility

The policies and procedures for conducting trials in critical care environments must be closely analyzed prior to bring on any sites.

Critical care typically requires fast decision-making, and there can be no surprises regarding physician collaboration and unit processes.

Characteristics of a Qualified CRA

Studies targeting hospitalized subjects are challenging to monitor, and CRAs must possess the right skills for the job.

This may include:

• a strong knowledge of medical terminology
• familiarity with pharmacology and critical care nursing
• ability to devote an adequate amount of time to reviewing potentially complex and dense medical records