Improving the quality of cancer clinical trials : workshop summary / National Cancer Policy Forum, Margie Patlack and Sharyl Nass, rapporteurs.

Format:

Book

Contributor:

Patlak, Margie.

Nass, Sharyl J.

National Cancer Policy Forum (U.S.)

Institute of Medicine (U.S.)

Language:

English

Subjects (All):

Cancer--Treatment--United States.

Cancer.

Clinical trials.

Physical Description:

xii, 124 p. : ill. (some col.).

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academies Press, c2008.

Language Note:

English

Summary:

Scientists and clinicians seek a new paradigm that could improve the efficiency, cost-effectiveness, and overall success rate of cancer clinical trials, while maintaining the highest standards of quality. To explore innovative paradigms for cancer clinical trials and other ways to improve their quality, the National Cancer Policy Forum held a workshop, Improving the Quality of Cancer Clinical Trials, in Washington, DC. The main goals of the workshop were to examine new approaches to clinical trial design and execution that would: (1) better inform decisions and plans of those responsible for developing new cancer therapies (2) more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic (3) be less costly than current trials The resulting workshop summary will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward.

Contents:

Introduction

New clinical trial designs. Phase 0 trials

Adaptive trial designs

Targeting multiple pathways with multiple drugs

Preclinical model systems

Molecular imaging. Current and developing methods

Challenges of molecular imaging

Screening for predictive markers. The challenges of clinical validation

Bioimaging predictive markers

Clinical translation

Panel discussion

Costs of clinical trials. Regulatory costs

Patient accrual

Global outsourcing

Time is money

Public-private collaborations

Regulatory issues. Regulatory barriers to innovation

Patient advocacy perspective

Regulation of in vitro diagnostics

Regulatory issues in improving cancer clinical trials

Reports from the case study discussion groups. Adaptive trial design

Phase 0 trials

Imaging

Use of proteomics/genomics to assign therapy in lung cancer

Use of genetics/genomics to assign therapy.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references.

ISBN:

0-309-17825-8

1-281-72680-X

9786611726805

0-309-11669-4

OCLC:

923278949