Benefit in Phase 1 Oncology Trials: Therapeutic Misconception or Reasonable Treatment Option?
ABSTRACT Novel treatments for cancer are tested initially in phase 1 trials enrolling patients with advanced disease who have exhausted standard treatment options. Although these trials are designed to evaluate safety and to define dosing for future efficacy trials, most patients volunteer with the hope of obtaining medical benefit. Do phase 1 oncology trials promote a 'therapeutic misconception' among eligible patients about the personal meaning of trial participation, or do they offer them a reasonable prospect of direct medical benefit as compared with available alternatives? Recent evidence on outcomes of phase 1 oncology trials is examined systematically, with the aim of accurately assessing the prospect of direct medical benefit for participants and drawing implications for informed consent. We argue that, in view of important uncertainties, aggregate data from phase 1 trials relating to the surrogate outcomes of tumor shrinkage and stable disease do not permit any definitive estimate of a 'clinical benefit rate.' Nevertheless, these trials do offer participants a prospect of direct medical benefit. As a result, accurately informed patients may reasonably decide to enroll in phase 1 oncology trials in hopes of obtaining benefit, after considering the anticipated risks and available clinical alternatives. Motivation to enroll in these studies to receive personal benefit does not, in itself, compromise informed consent.
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- "First, it might be claimed that the relevant standard of competent care outside the study is not " no treatment. " Indeed, some commentators have argued—in the context of cancer Phase 1 trials—that the risks and benefits of study participation should be compared against the risks and benefits posed by nonvalidated anticancer agents that treatment refractory patients might receive outside a study (Miller and Joffe 2008 "
ABSTRACT: Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study--first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two provisional conclusions: (1) the risks of drug administration in such trials cannot generally be justified on therapeutic grounds but by appeal to the social value of the research; and (2) a framework for adjudicating the ratio of risk/social-value must be developed.Kennedy Institute of Ethics journal 03/2010; 20(1):75-98. DOI:10.1353/ken.0.0307 · 1.21 Impact Factor
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ABSTRACT: The document describes the main aspects that researchers should consider in the design of human experimentation protocols, and particularly of clinical trials in oncology. Cancer clinical trials are characterized by several ethically relevant peculiarities. Among these there are, for example, the informed consent and the risk/benefit balance. The main aspects of protocol organization and of the protection of human subjects are described. The text is complimentary to another forthcoming report on the ethics of oncology trials. The text is addressed to researchers and clinicians who perform clinical trials; the complementary report is addressed to the members of ethics committees. Key words: Bioethics, Clinical trial, Ethics Committees, Oncology
Conference Paper: A technology audit: key to technology planning[Show abstract] [Hide abstract]
ABSTRACT: The technology possessed by an organization may be even more valuable than the resources evaluated in a financial audit. What technology does an organization possess, both product and process? How much of it is the same technology the organization's competitors possess? How much of it gives the organization a competitive edge? How much of it will provide a competitive edge in the future? Is the technology on which the organization depends for competitive status verging on obsolescence? A technology audit is intended to evaluate the state of the organization's technology resources. These can be classified as base technologies, possessed by every firm in the industry, key technologies those which provide the firm with a competitive edge, and pacing technologies (those needed to provide a competitive edge in the future). This paper presents a methodology for conducting a technology audit. The paper identifies the critical issues which must be addressed in a technology audit. A systematic procedure is then presented for identifying the technologies involved in the organizations products and processes. Methods for evaluating these technologies for competitive status are then described. Finally, a method is presented for preparing a profile of the organization's technological statusAerospace and Electronics Conference, 1994. NAECON 1994., Proceedings of the IEEE 1994 National; 06/1994