Chapter-37 Herbal Drug Food-A Perspective

Bawa, A. S.

doi:10.5005/jp/books/10776_37

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Nanomedicine Hype and Fih Trials1

Strengthening Fih Nanotrial Oversight1

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2012

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“…At this point, cancer is the most active nanomedical research area. Nanotrials have already involved subjects with untreatable cancer, 54 and many trials are ongoing. 55 The National Cancer Institute (NCI) is an ardent nanotechnology supporter.…”

Section: Nanomedicine Hype and Fih Trialsmentioning

confidence: 99%

“…The FDA could enhance its oversight by developing better preclinical tests to evaluate the safety of nanoscale materials; the agency could also require research sponsors to submit data from such tests when they seek permission to conduct FIH nanotrials. 61 Some analysts call for the creation of a national nanomedicine research oversight body with duties similar to the NIH Recombinant DNA Advisory Committee. 62 Alternatively, the NIH could collect review materials from IRBs evaluating FIH nanotrials and make them available to other IRBs considering similar trials.…”

Section: Strengthening Fih Nanotrial Oversightmentioning

confidence: 99%

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Building an Ethical Foundation for First-in-Human Nanotrials

Dresser

2012

J. Law. Med. Ethics

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Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.

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Section: Nanomedicine Hype and Fih Trialsmentioning

confidence: 99%

Section: Strengthening Fih Nanotrial Oversightmentioning

confidence: 99%