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Single-Patient Expanded Access Requests: IRB Professionals' Experiences and Perspectives.

08:00 EDT 9th April 2019 | BioPortfolio

Summary of "Single-Patient Expanded Access Requests: IRB Professionals' Experiences and Perspectives."

U.S. physicians may treat a patient with an investigational drug outside of a clinical trial by using the expanded access (EA) pathway or the recently created federal right to try (RTT) pathway. The EA pathway requires physicians to get prior permission from the U.S. Food and Drug Administration (FDA) and, except in emergency cases, institutional review board (IRB) approval. The perspectives of IRB professionals on the review of single-patient EA requests have not been empirically studied.

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Journal Details

This article was published in the following journal.

Name: AJOB empirical bioethics
ISSN: 2329-4523
Pages: 1-12

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Medical and Biotech [MESH] Definitions

Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial.

The services rendered by members of the health profession and non-professionals under their supervision for the benefit of the patient. (From Dorland, 28th ed, p269)

Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.

The concurrent or retrospective review by practicing physicians or other health professionals of the quality and efficiency of patient care practices or services ordered or performed by other physicians or other health professionals (From The Facts On File Dictionary of Health Care Management, 1988).

Voluntarily-formed groups of healthcare professionals who join for common management services and other benefits such as collective bargaining agreements with reimbursement agents. The physical assets of a practice are controlled by the MSO which also provides billing, collections, and similar services. The practitioner retains control of patient records and management of patient care.

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