[Informed consent in phase I trial].

Y Shimada

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PubMed · 8611051

[Informed consent in phase I trial].

Y Shimada

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Abstract

Informed consent in phase I trials involves very difficult problems related to experimental factors of the phase I trial, a toxicity study conducted in human cancer patients. However, this is the first clinical step in new drug development, and patients must participate in phase I only when there is full disclosure of correct trial information. Disclosure should include the purpose of the trial, the procedure, and the risk/benefits related to the trial. Informing the patient of the cancer diagnosis and the extent of disease is also necessary before entry into a phase I trial. Although phase I trials are conducted with the precious contribution of patients, it is important that informed consent should not become a type of legal contract. Informed consent in phase I trials is an essential process, just like a roundtable discussion of patient and physician before fighting an incurable cancer.

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Antineoplastic Agents Clinical Trials, Phase I as Topic Humans Informed Consent Neoplasms Truth Disclosure English Abstract Journal Article Review

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Y Shimada. 1996. [Informed consent in phase I trial].. https://pubmed.ncbi.nlm.nih.gov/8611051/

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