Downloadable Insights

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

Exploring Standard CRO Timeline Benchmarks

Preparing to work with a top biometrics contract research organization and wondering how their promised data management, biostatistics, and medical writing timelines match up to the industry average? To help sponsors dig into these details and ensure the timelines they’re receiving are competitive, we’re providing PharPoint’s typical timelines alongside research that calculates industry standard timelines, when available.

Our hope is that this document can help sponsors set realistic expectations, confidently ask the right questions of their vendors, and ultimately, partner with a top biometrics CRO that keeps their study moving: because patients are waiting.

eBook contents include:

PharPoint’s short eBook, Standard Clinical Trial Timelines: A Sponsor’s Guide to Evaluating Biometrics CROs, includes the below information.

• Standard database build timeline
  • The bigger picture: Considering site identification and study start-up
• Standard mid-study database change timeline
• Standard database lock time
  • Six strategies for a faster database lock
• Evaluating database lock to top line results timeline
  • Ensuring a rapid delivery
• Evaluating database lock to delivery of tables, listings, and figures (TLF) timeline
• Standard clinical study report delivery timeline
• About PharPoint Research