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Case History

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Image not available. A 69-year-old woman with metastatic breast cancer is admitted to hospital overnight with a history of haematemesis; she has no previous history of gastrointestinal (GI) problems. The patient says she is taking part in a trial comparing chemotherapy against an investigational oral drug (or placebo), and last took the study drug that morning. On admission, she is hypotensive and requires resuscitation with blood and intravenous fluids; she undergoes an upper GI endoscopy that shows a bleeding duodenal ulcer. The following morning the patient has stabilized, and the research nurse asks you to complete an assessment of this event as part of your responsibility as a named sub-investigator on the trial.

How would you assess and record this patient's acute event?

How would you report adverse events in a case like this?

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Background

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Image not available. Clinical trials are conducted by local teams of doctors, nurses and support staff, led by the 'Principal Investigator' (PI). A sub-investigator is a member of the clinical trial team (usually a doctor or a research nurse) who is designated to perform critical trial-related procedures and/or to make important trial-related decisions.1 Anyone involved in the conduct of clinical trials must be trained in the principles of clinical trial practice. These principles have been agreed internationally, and are bound by both international and UK law.

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The International Conference on Harmonisation of Good Clinical Practice (ICH-GCP) guideline is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.2 The objective of the ICH-GCP guideline is to provide a unified international standard to facilitate the mutual acceptance of clinical data by the various regulatory authorities. Compliance with GCP provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Prospective PIs and sub-investigators must complete training in ICH-GCP and may be required to pass an examination prior to involvement in clinical trials.

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Fundamental to the conduct of clinical trials is the protection of human rights and the dignity of human beings, as reflected in the 1996 version of the Declaration of Helsinki.3 In the UK, the Department of Health has published detailed documents for the governance of clinical research undertaken in the NHS. These are the 'Research Governance Framework for Health and Social Care' and 'The Medicines for Human Use (Clinical Trials) Regulations 2004'.4,5

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Trial participants are protected through risk assessment by various competent authorities prior to the commencement of a clinical trial. These include the judgement of the Main Research Ethics Committee (MREC),6 and if the trial involves a medicine or a medical device, permission from the Medicines and Healthcare Products Regulatory Agency (MHRA) would also be required.7

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How would you assess and record this patient's acute event?

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