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The unique challenges of enrolling patients into multiple clinical trials

Adrienne G Randolph1

  • 1Children's Hospital, Harvard Medical School, Boston, MA, USA. adrienne.randolph@childrens.harvard.edu

Critical Care Medicine
|December 24, 2008
PubMed

Insights

Enrolling critically ill patients in multiple clinical trials, known as coenrollment, can speed up research. Evidence suggests patients and families are willing to participate and do not experience excessive stress.

Area of Science:

  • Critical Care Medicine
  • Clinical Trials
  • Research Methodology

Background:

  • Numerous interventions exist for critically ill patients, but their therapeutic value is often unproven.
  • Current practices discourage enrolling intensive care unit (ICU) patients in multiple studies, hindering research efficiency.
  • Potential risks include intervention interactions and increased family stress due to repeated consent processes.

Purpose of the Study:

  • To provide a rationale for the coenrollment of intensive care unit patients into multiple clinical trials.
  • To explore the efficiency gains and address concerns associated with coenrollment.
  • To advocate for the promotion of coenrollment policies in critical care research.

Main Methods:

  • Review of existing literature and evidence regarding patient and family attitudes towards coenrollment.
  • Discussion of the benefits of efficient study designs, such as factorial designs, while acknowledging limitations.
  • Exploration of necessary modifications in consent, data collection, and analysis for effective coenrollment.

Main Results:

  • Limited available evidence indicates that most patients are willing to enroll in multiple studies.
  • Patients and their families generally do not report feeling overly stressed by participating in more than one study.
  • Coenrollment can be facilitated through modifications in subject consent, data collection, and data analysis procedures.

Conclusions:

  • Coenrollment of critically ill patients in multiple clinical trials offers a more efficient approach to testing interventions.
  • Addressing concerns through modified protocols can support patient and family participation.
  • Thoughtful promotion and implementation of coenrollment policies are crucial for advancing critical care research.

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