Contemporary Issues
Good clinical practice in trauma care research: Considerations for inter-hospital patient transfers

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Introduction

All clinical research is carried out under a legal and governance framework, which embeds the principles of Good Clinical Practice (GCP) derived from the Declaration of Helsinki (NIHR, 2013). GCP principles are embedded into the standard operating procedures of NHS Trusts in order to achieve ethical, legal and professional compliance. In most clinical trials patient care is carried out within a single healthcare provider; however, major trauma patients are often transferred between hospitals to allow for best medical care (Hoyt and Coimbra, 2007), therefore clinical trials in these patients often involve more than one institution. This can give rise to a number of problems that need to be addressed by the research nurses in order to successfully deliver trauma research within a GCP framework. In this paper we present the issues and solutions that have been encountered in the setup of an emergency care trial.

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Literature review

A search was performed to identify literature already available on the topic using the search strategy (Box 1) within the PubMed database. The result of this search was negative as there were no previous articles found on this subject.

An example – the CRASH-3 trial

The CRASH-3 trial is a large international randomised, double blind placebo controlled trial of the use of tranexamic acid for the treatment of significant traumatic brain injury (Dewan et al., 2012). Many of the patients will require an inter-hospital transfer for neurosurgical care, yet the trial treatment needs to be initiated early, before the transfer takes place. So patients are entered into the trial, but then almost immediately transferred to another hospital. This raises a number of

Discussion

Modern trauma care is now usually delivered at a Trauma System level across more than one hospital; however, the bureaucracy of research governance functions at individual hospital level. This discordance between the research system and the clinical care system leads to the issues previously discussed for which research nurses are required to find solutions (Future Hospital Commission, 2014).

Trauma research nurses need to work together at Trauma System level to make sure that good communication

Conclusion

Research regulation often assumes that patients stay in one hospital for all of their treatment. However, the development of regional care systems (such as trauma, cancer and cardiac) means that alternative arrangements have to be devised that are both legal and practical. This requires flexibility and new ways of working for both regulators and research nurses. Effective delivery of trauma care studies requires research nurses to work collaboratively across institutional boundaries to ensure

References (10)

  • HoytD.B. et al.

    Trauma systems

    The Surgical Clinics of North America

    (2007)
  • BargajeC.

    Good documentation practice in clinical research

    Perspectives in Clinical Research

    (2011)
  • DewanY. et al.

    CRASH-3 – tranexamic acid for the treatment of significant traumatic brain injury: study protocol for an international randomized, double-blind, placebo-controlled trial

    Trials

    (2012)
  • FarrellB. et al.

    Managing clinical trials

    Trials

    (2010)
  • Future Hospital Commission

    Future hospital: caring for medical patients

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