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Case History

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Image not available. The concerned wife of a 54-year-old man calls the acute oncology unit. She tells you that her husband has brain cancer, and has recently started an experimental tablet at your hospital as part of a small clinical trial that will include only a few patients. She thinks he has had a fit lasting approximately three minutes, but appears to be recovering now. His last fit was one year ago, several months prior to commencing the trial.

The patient is taking part in a small trial, possibly phase I. It is difficult to determine from the information presented whether the drug is previously untested in patients (a first-in-humans study), or whether it has been previously tested and is now being given for a new indication. If the latter is true, more information regarding the expected side effects may already be available.

What is a clinical trial and who may participate?

Where should patients involved in trials be admitted acutely?

How should patients in trials be managed?

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Background

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Image not available. Clinical research is central to oncology, and in the UK as many as 20% of patients may be enrolled into clinical studies. Such patients may experience acute episodes, possibly due to the study treatments. In early clinical trials these may be new or unexpected events. Patients in trials who present acutely may therefore be especially challenging for the acute oncology team (AOT).

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What is a clinical trial and who may participate?

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Clinical trials are generally considered to be biomedical or health-related research studies in human beings that follow a predefined protocol. In oncology, the majority of these clinical trials are interventional, with patients assigned to a treatment or other intervention. Observational studies are those in which individuals are observed without intervention in order to measure predefined outcomes.1

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All clinical trials have guidelines, including inclusion and exclusion criteria that define who can participate. These criteria not only help to keep the participants safe, but they also help to identify appropriate participants to ensure that researchers will be able to answer the questions they plan to study.2 Examples of criteria include the type and stage of the cancer, molecular characteristics of their tumour (including genetic mutations), previous treatment history, and other medical conditions.

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Clinical trials are traditionally conducted in four phases, each of which has a different purpose and help to answer different questions.3,4 Table 45.1 lists the approximate number of participants and primary and secondary measures (endpoints) for each phase of a clinical trial.

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Table Graphic Jump Location
Table 45.1The four phases of clinical trials in oncology

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