Clinical Trials: What You Need to Know

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Summing it all up

References

Bennett C, Adams J, Knox K, et al. Clinical trials: Are they a good buy? J Clin Oncol. 2001;19:4330-4339.

Coalition of Cancer Cooperative Groups. Most cancer patients satisfied with clinical trial experience, yet, few aware of opportunity: study shows improved physician-patient communications could increase enrollment in cancer clinical trials [press release]. June 5, 2006. Accessed at www.cancertrialshelp.org/CTHpdf/CancerPatientsSatisfied5June06.pdf on September 21, 2012.

Dilts DM, Sandler A, Cheng S, et al. Steps and time to process clinical trials at the Cancer Therapy Evaluation Program. J Clin Oncol. 2009;27(11):1761-1766.

Doroshaw JH. Phase ‘0’ Clinical Trials in Cancer Drug Development: From Concept to Practice. Slide presentation. Accessed at www.iom.edu/~/media/Files/Activity%20Files/Disease/NCPF/Phase0ClinicalTrialsinCancerDrugDevelopmentFromConcepttoPracticeDoroshow.pdf on September 21, 2012.

ECRI: Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness. ECRI; February 2002. Accessed at www.ecri.org/Documents/Clinical_Trials_Patient_Reference_Guide.pdf on September 21, 2012.

Getz K, Borfitz D. Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston, Mass: CenterWatch; 2002.

National Cancer Institute. Learning About Clinical Trials. Accessed at www.cancer.gov/clinicaltrials on September 26, 2012.

National Cancer Institute. Monitoring the Safety of Clinical Trials. Accessed at www.cancer.gov/clinicaltrials/patientsafety/monitoring-safety-of-trials on September 20, 2012.

National Cancer Institute. New Approaches to Cancer Drug Development and Clinical Trials: Questions and Answers. Accessed at www.cancer.gov/newscenter/pressreleases/PhaseZeroNExTQandA/print?page=&keyword= on September 20, 2012.

Pharmaceutical Research and Manufacturers of America (PhRMA). 2012 Report: Medicines in Development, Cancer. Accessed at www.phrma.org/sites/default/files/1000/phrmamedicinesindevelopmentcancer2012.pdf on September 20, 2012.

Streiner DL, Norman GR. Drug Trial Phases. Community Oncology. 2009;6(1):36-40.

Stryker JE, Wray RJ, Emmons KM, Winer E, Demetri G. Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret. Patient Educ Couns. 2006;63(1-2):104-109.

Tufts Center for the Study of Drug Development 2001: Backgrounder: How new drugs move through the development and approval process. Accessed at http://csdd.tufts.edu/files/uploads/how_new_drugs_move.pdf on September 21, 2012.

US Department of Health and Human Services. Medicare and Clinical Research Studies. March 2010. Accessed at www.medicare.gov/Publications/Pubs/pdf/02226.pdf on September 20, 2012.

US Department of Health, Education, and Welfare. The Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research, 1979. Accessed at www.hhs.gov/ohrp/humansubjects/guidance/belmont.html on September 20, 2012.

US Food and Drug Administration. Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use. Accessed at www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm on September 21, 2012.

US Food and Drug Administration. Investigational New Drug Application. Accessed at www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm on September 20, 2012.

US Food and Drug Administration. New Drug Development Timeline. Accessed at www.fda.gov/fdac/graphics/newdrugspecial/drugchart.pdf on April 29, 2008. Content no longer available.


Last Medical Review: 09/21/2012
Last Revised: 09/21/2012