The death of a healthy volunteer in a human research project: implications for Australian clinical research

Day, R. O.; Chalmers, Don; Williams, Kiah M; Campbell, Teresa

doi:10.5694/j.1326-5377.1998.tb139026.x

Cited by 53 publications

(20 citation statements)

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“…Es existieren einige wenige Daten zum allgemeinen Risiko für gesunde Probanden in Arzneimittelprüfungen, nicht aber speziell zum Risiko bei einer Erstanwendung in der Phase I. Einer britischen Erhebung zufolge zeigten von 863 gesunden Probanden, die innerhalb eines Jahres an Arzneimittelprüfungen teilnahmen, 565 (6,9%) leichte und 45 (0,55%) mäßiggradige unerwünsch-te Arzneimittelwirkungen [29]. Nur vereinzelt wird von bleibenden Schäden ( Fall unter 49.985 gesunden Probanden [30]) und von lebensbedrohlichen Reaktionen [3] oder Todesfällen [30,32] unter gesunden Probanden in klinischen Arzneimittelprüfungen berichtet. Als Gründe für Zwischenfälle kommen meist Wechselwirkungen durch die Einnahme nicht erlaubter Medikamente oder durch Genussmittel sowie durch eine unzulässige gleichzeitige oder kurzfristig wiederholte Teilnahme an mehreren klinischen Prüfungen in Frage.…”

Section: Risiko Für Probanden Bei Der Erstanwendung In Der Phase Iunclassified

Arzneimittelforschung

Miletzki

Ch²

2005

Bundesgesundheitsbl - Gesundheitsf - Gesundheitsschutz

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Phase I clinical trials are of particular importance in drug research. In this phase, a new chemical entity is applied for the first time to humans, normally to young healthy volunteers. The primary aims are safety and tolerability, the pharmacokinetic, and as far as possible the pharmacodynamic behaviour of the new substance in the human body. The effects of age, gender, race, drug interactions, food intake and organ damage are examined in studies of later phase I. This article deals mainly with "first into human" studies during early phase I. We describe the processes before, as well as the technical, medical and regulatory requirements during, the conduct of a "first into human" trial. Furthermore, the choice of galenic formulation, route of application, and study population, and the risks at trial participation are addressed. In addition to different dose escalating schemes, which serve for the identification of the maximum tolerated dose, and other common study designs for "first into human" trials, this article reviews the literature on the determination of the first dose.

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Section: Risiko Für Probanden Bei Der Erstanwendung In Der Phase Iunclassified

Arzneimittelforschung

Miletzki

Ch²

2005

Bundesgesundheitsbl - Gesundheitsf - Gesundheitsschutz

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“…Auf die Gefahr der Überdosierung von Lidocain als topisches Lokalanäs-thetikum [17,22,29,80,85,108] wurde bereits hingewiesen.…”

Section: Spezielle Komplikationenunclassified

Anästhesiologisches Management zur Endoskopie der Atemwege bei Kindern

Machotta

2002

Der Anaesthesist

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We have developed a modern strategy for the anaesthetic management of the pediatric airway using anaesthetic drugs such as sevoflurane, propofol, mivacurium and remifentanil, together with new techniques including the laryngeal mask. This strategy provides optimal conditions for the examiner and maximum safety for the pediatric patient. The endoscopic investigation of pediatric airways has become important for the diagnosis and treatment of many pediatric diseases, and is often performed with the support of a pediatric anaesthetist. Important indications include acute and chronic stridor, chronic obstructive airway disease, mucoviscidosis and foreign body aspiration. The best and safest techniques are outlined depending on the clinical situation, and the most frequent complications are discussed, e.g. hypoxaemia, respiratory arrest, laryngospasm, bronchial obstruction, pneumothorax and overdosing of local anaesthetic agents.

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“…notified of a healthy 19-year-old college student volunteer in a clinical research program undergoing a bronchoscopy who died as a result of acute lignocaine toxicity. [4]…”

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confidence: 99%