Critical Care CRO:
Best Practices for Conducting Critical Care Clinical Trials


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.

Planning, executing, managing, and analyzing critical care trials requires an agile and experienced critical care CRO team.


Site Selection, Enrollment, and Recruitment

The policies and procedures for conducting trials in critical care environments must be closely analyzed before bringing on any sites. Critical care patients often require fast decision-making, and there can be no surprises regarding physician collaboration/unit processes.

Additionally, it’s crucial to ensure every site has its own internal process for obtaining informed consent from legally authorized representatives (LARs).

Predicting enrollment rates in critical care trials is especially difficult, as it’s hard to determine which kind of patients may arrive at sites. Principal Investigators (PIs) drive recruitment within critical care. Good experience and positive working relationships with these investigators are essential to keeping a study top of mind at the site level.

21 CFR 50.3(I)
A legally authorized representative is “an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.”



The rate of misdiagnoses within the fast-paced critical care environment may be estimated at around 10-12%. This may impact enrollment rates, and additional precautions may be taken to mitigate the risk of misdiagnosis.


Obtaining Informed Consent

The process of obtaining informed consent in a critical care trial often looks different than in other areas due to the nature of the subjects involved. In some instances, subjects may be incapable of providing their consent personally if they are unconscious or otherwise incapacitated (which, in critical care, they often are).

In these situations, subjects may be enrolled with the consent of the LAR, which is typically a guardian, family member, or spouse. In the United States, individual state laws must be considered to ensure all requirements for surrogate consent are followed at each site.

In all research, informed consent is an ongoing process, and applicable criteria trigger the re-consenting of a subject.


Site Management and Monitoring

Studies targeting hospitalized subjects are more challenging to monitor, and CRAs must possess the right skills for the job. This includes a strong knowledge of medical terminology and familiarity with pharmacology and critical care nursing. Medical records can be complex and dense, and adequate time must be planned to review records properly.

Additionally, study teams must facilitate communication between site staff and the study’s medical monitor. Patient care is 24/7, and questions may arise during non-business hours. A medical monitor, provided by the Sponsor or through a third party such as a critical care CRO, must be on call 24/7.


PharPoint Research is a ful-service CRO with the right experience to seamlessly support a critical care trial.

  • PharPoint’s on-team MD has experience within critical care
  • Thorough, data-driven site feasibility process ensures the best sites are selected
  • Team focuses on a predictive study startup – ensuring study processes and logistics are clear and all study partners are equipped to handle potential challenges
  • Postitive working relationships with site staff keep your study top-of-mind
  • Studies are equipped with monitors who have a strong knowledge of medical terminology and familiarity with pharmacology and critical care nursing
  • Industry best biometrics timelines, so Sponsors get results faster