A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms /:
This report for the National Cancer Policy Board (NCPB) describes the procedures currently in place in the United States for approving and monitoring clinical trials of cancer treatments. Virtually all cancer clinical trials are funded by agencies of the federal government or the pharmaceutical indu...
Gespeichert in:
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| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Washington D.C. :
National Research Council,
1999.
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | This report for the National Cancer Policy Board (NCPB) describes the procedures currently in place in the United States for approving and monitoring clinical trials of cancer treatments. Virtually all cancer clinical trials are funded by agencies of the federal government or the pharmaceutical industry, so the focus is on the requirements for each of these groups. The paper is intended as a jumping off point for the NCPB to consider some of the pressing policy issues surrounding clinical trials in cancer, though as yet, no specific follow-on projects have been initiated. |
| Beschreibung: | Title from caption (viewed June 14, 2001). "February 1999." |
| Beschreibung: | 1 online resource |
| Bibliographie: | Includes bibliographical references. |
| ISBN: | 0309583012 9780309583015 |
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| 520 | 3 | |a This report for the National Cancer Policy Board (NCPB) describes the procedures currently in place in the United States for approving and monitoring clinical trials of cancer treatments. Virtually all cancer clinical trials are funded by agencies of the federal government or the pharmaceutical industry, so the focus is on the requirements for each of these groups. The paper is intended as a jumping off point for the NCPB to consider some of the pressing policy issues surrounding clinical trials in cancer, though as yet, no specific follow-on projects have been initiated. | |
| 505 | 0 | |a A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Machanisms -- Copyright -- Preface -- Report Reviewers -- Contents -- SUMMARY -- Cancer Treatment Trial Sponsors -- Quality Standards for Cancer Treatment Trials -- Common Elements of Clinical Trial Review Criteria -- Reviews for Scientific Merit -- Reviews and Procedures to Ensure the Safety and Rights of Participants -- INTRODUCTION -- ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS -- CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS | |
| 505 | 8 | |a The Two Prongs of Clinical Trial Protocol Review and MonitoringThe National Cancer Institute -- The Cancer Therapy Evaluation Program -- The Cancer Centers Program -- Department of Veterans Affairs -- The Cooperative Studies Program -- VA-Funded Research at Single VA Medical Centers -- INSTITUTIONAL REVIEW BOARDS -- THE FOOD AND DRUG ADMINISTRATION -- The Commercial IND Application -- Noncommercial INDs -- Protection of Human Subjects -- COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA -- Reviews for Scientific Merit | |
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| contents | A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Machanisms -- Copyright -- Preface -- Report Reviewers -- Contents -- SUMMARY -- Cancer Treatment Trial Sponsors -- Quality Standards for Cancer Treatment Trials -- Common Elements of Clinical Trial Review Criteria -- Reviews for Scientific Merit -- Reviews and Procedures to Ensure the Safety and Rights of Participants -- INTRODUCTION -- ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS -- CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS The Two Prongs of Clinical Trial Protocol Review and MonitoringThe National Cancer Institute -- The Cancer Therapy Evaluation Program -- The Cancer Centers Program -- Department of Veterans Affairs -- The Cooperative Studies Program -- VA-Funded Research at Single VA Medical Centers -- INSTITUTIONAL REVIEW BOARDS -- THE FOOD AND DRUG ADMINISTRATION -- The Commercial IND Application -- Noncommercial INDs -- Protection of Human Subjects -- COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA -- Reviews for Scientific Merit |
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| spelling | Gelband, Hellen. A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / Hellen Gelband ; prepared for the National Cancer Policy Board. Washington D.C. : National Research Council, 1999. 1 online resource text txt rdacontent computer c rdamedia online resource cr rdacarrier Title from caption (viewed June 14, 2001). "February 1999." Includes bibliographical references. This report for the National Cancer Policy Board (NCPB) describes the procedures currently in place in the United States for approving and monitoring clinical trials of cancer treatments. Virtually all cancer clinical trials are funded by agencies of the federal government or the pharmaceutical industry, so the focus is on the requirements for each of these groups. The paper is intended as a jumping off point for the NCPB to consider some of the pressing policy issues surrounding clinical trials in cancer, though as yet, no specific follow-on projects have been initiated. A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Machanisms -- Copyright -- Preface -- Report Reviewers -- Contents -- SUMMARY -- Cancer Treatment Trial Sponsors -- Quality Standards for Cancer Treatment Trials -- Common Elements of Clinical Trial Review Criteria -- Reviews for Scientific Merit -- Reviews and Procedures to Ensure the Safety and Rights of Participants -- INTRODUCTION -- ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS -- CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS The Two Prongs of Clinical Trial Protocol Review and MonitoringThe National Cancer Institute -- The Cancer Therapy Evaluation Program -- The Cancer Centers Program -- Department of Veterans Affairs -- The Cooperative Studies Program -- VA-Funded Research at Single VA Medical Centers -- INSTITUTIONAL REVIEW BOARDS -- THE FOOD AND DRUG ADMINISTRATION -- The Commercial IND Application -- Noncommercial INDs -- Protection of Human Subjects -- COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA -- Reviews for Scientific Merit Cancer Treatment. http://id.loc.gov/authorities/subjects/sh85019547 Oncology Research. Clinical trials. http://id.loc.gov/authorities/subjects/sh85027069 Neoplasms therapy https://id.nlm.nih.gov/mesh/D009369Q000628 Clinical Trials as Topic https://id.nlm.nih.gov/mesh/D002986 Clinical Trials as Topic standards https://id.nlm.nih.gov/mesh/D002986Q000592 United States https://id.nlm.nih.gov/mesh/D014481 Cancer Traitement. Cancérologie Recherche. Études cliniques. MEDICAL Preventive Medicine. bisacsh MEDICAL Forensic Medicine. bisacsh MEDICAL Public Health. bisacsh Cancer Treatment fast Clinical trials fast Oncology Research fast National Cancer Policy Board (U.S.) http://id.loc.gov/authorities/names/n98801305 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=123575 Volltext |
| spellingShingle | Gelband, Hellen A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Machanisms -- Copyright -- Preface -- Report Reviewers -- Contents -- SUMMARY -- Cancer Treatment Trial Sponsors -- Quality Standards for Cancer Treatment Trials -- Common Elements of Clinical Trial Review Criteria -- Reviews for Scientific Merit -- Reviews and Procedures to Ensure the Safety and Rights of Participants -- INTRODUCTION -- ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS -- CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS The Two Prongs of Clinical Trial Protocol Review and MonitoringThe National Cancer Institute -- The Cancer Therapy Evaluation Program -- The Cancer Centers Program -- Department of Veterans Affairs -- The Cooperative Studies Program -- VA-Funded Research at Single VA Medical Centers -- INSTITUTIONAL REVIEW BOARDS -- THE FOOD AND DRUG ADMINISTRATION -- The Commercial IND Application -- Noncommercial INDs -- Protection of Human Subjects -- COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA -- Reviews for Scientific Merit Cancer Treatment. http://id.loc.gov/authorities/subjects/sh85019547 Oncology Research. Clinical trials. http://id.loc.gov/authorities/subjects/sh85027069 Neoplasms therapy https://id.nlm.nih.gov/mesh/D009369Q000628 Clinical Trials as Topic https://id.nlm.nih.gov/mesh/D002986 Clinical Trials as Topic standards https://id.nlm.nih.gov/mesh/D002986Q000592 Cancer Traitement. Cancérologie Recherche. Études cliniques. MEDICAL Preventive Medicine. bisacsh MEDICAL Forensic Medicine. bisacsh MEDICAL Public Health. bisacsh Cancer Treatment fast Clinical trials fast Oncology Research fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh85019547 http://id.loc.gov/authorities/subjects/sh85027069 https://id.nlm.nih.gov/mesh/D009369Q000628 https://id.nlm.nih.gov/mesh/D002986 https://id.nlm.nih.gov/mesh/D002986Q000592 https://id.nlm.nih.gov/mesh/D014481 |
| title | A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / |
| title_auth | A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / |
| title_exact_search | A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / |
| title_full | A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / Hellen Gelband ; prepared for the National Cancer Policy Board. |
| title_fullStr | A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / Hellen Gelband ; prepared for the National Cancer Policy Board. |
| title_full_unstemmed | A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / Hellen Gelband ; prepared for the National Cancer Policy Board. |
| title_short | A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / |
| title_sort | report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms |
| topic | Cancer Treatment. http://id.loc.gov/authorities/subjects/sh85019547 Oncology Research. Clinical trials. http://id.loc.gov/authorities/subjects/sh85027069 Neoplasms therapy https://id.nlm.nih.gov/mesh/D009369Q000628 Clinical Trials as Topic https://id.nlm.nih.gov/mesh/D002986 Clinical Trials as Topic standards https://id.nlm.nih.gov/mesh/D002986Q000592 Cancer Traitement. Cancérologie Recherche. Études cliniques. MEDICAL Preventive Medicine. bisacsh MEDICAL Forensic Medicine. bisacsh MEDICAL Public Health. bisacsh Cancer Treatment fast Clinical trials fast Oncology Research fast |
| topic_facet | Cancer Treatment. Oncology Research. Clinical trials. Neoplasms therapy Clinical Trials as Topic Clinical Trials as Topic standards United States Cancer Traitement. Cancérologie Recherche. Études cliniques. MEDICAL Preventive Medicine. MEDICAL Forensic Medicine. MEDICAL Public Health. Cancer Treatment Clinical trials Oncology Research |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=123575 |
| work_keys_str_mv | AT gelbandhellen areportonthesponsorsofcancertreatmentclinicaltrialsandtheirapprovalandmonitoringmechanisms AT nationalcancerpolicyboardus areportonthesponsorsofcancertreatmentclinicaltrialsandtheirapprovalandmonitoringmechanisms AT gelbandhellen reportonthesponsorsofcancertreatmentclinicaltrialsandtheirapprovalandmonitoringmechanisms AT nationalcancerpolicyboardus reportonthesponsorsofcancertreatmentclinicaltrialsandtheirapprovalandmonitoringmechanisms |