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Case History

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Image not available. During an outpatient clinic, the next patient is a 35-year-old woman with metastatic sarcoma who has been taking part in a phase II clinical trial of a new intravenous investigational agent. Following her first dose, she suffered from neutropenic sepsis and severe diarrhoea, and required support on the high dependency unit. During the consultation, with a clinician who is a named sub-investigator in the trial, the patient informs the clinician that she would like to continue taking part in the trial.

The definition of informed consent according to The Medicines for Human Use (Clinical Trials) Regulations 2004 is that 'a person gives informed consent to take part in a clinical trial only if his/her decision is given freely after that person is informed of the nature, significance, implications and risks of the trial'.1

When and how should informed consent be taken for patients in clinical trials?

Does this patient's toxicity affect the validity of consent for other patients in the same trial?

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Background

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When and how should informed consent be taken for patients in clinical trials?

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Image not available. This patient will have given and recorded her consent to take part in the trial prior to any study-specific intervention. That would usually suffice. However, given that she has clearly suffered from a serious event, it is important to undertake further detailed discussions to ensure that if she does wish to remain in the trial, she does so with her fully informed consent.

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The process of valid informed consent to research participation is a continuous one. Following an adverse event such as this, it is important that the patient understands clearly what has occurred and, where it is possible to establish, why it occurred. This will inform discussion about the most appropriate management thereafter, including possible dose interruption, reduction or withdrawal from the study. The patient should be aware that they are free to withdraw from the study at any time without giving an explanation.2

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Whether the patient resumes treatment within the study following resolution or acceptable improvement of the adverse event will depend on several factors, including those mandated in the trial protocol. Important considerations are the Common Terminology Criteria for Adverse Events (CTCAE) grade of the event, level of intervention required and length of time to resolution; but also included is the medical judgement of the responsible physician. Likewise, the protocol will usually define changes to the dose or schedule of study drug if the patient remains on the trial. Again, the investigator has the responsibility to ensure that, if implemented, such changes in the study drug are in the patient's best interest. The patient's own wishes are also important.

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Does this patient's toxicity affect the validity of consent for other patients in the same trial?

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Following this episode, as a sub-investigator you may be involved in ...

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