- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before a clinical trial starts?
- Some facts about clinical trials to keep in mind
- What are the phases of clinical trials?
- Phase 0 clinical trials: Exploring if and how a new drug may work
- Phase I clinical trials: Is the treatment safe?
- Phase II clinical trials: Does the treatment work?
- Phase III clinical trials: Is it better than what’s already available?
- Submission for FDA approval: New drug application (NDA)
- Phase IV clinical trials: What else do we need to know?
- Who sponsors and runs clinical trials?
- Should I think about taking part in a clinical trial?
- Answers to some common questions about clinical trials
- Other questions you should ask your research team
- How are study participants protected?
- What’s out there? Finding clinical trials
- How do I figure out which study is for me?
- What about cost? Will my insurance cover it?
- Private insurers and the new health care law
- What would it be like to be in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
- To learn more
American Society of Clinical Oncology. Summary the Affordable Care Act Statute Regarding Insurance Coverage for Individuals Participating in Approved Clinical Trials. Accessed at www.asco.org/sites/default/files/aca_summary_clinical_trials.pdf on September 25, 2014.
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Center for Information and Study on Clinical Research Participation. 2013 Perceptions & Insights Study. Report on Study Participant Experiences. Accessed at www.ciscrp.org/wp-content/uploads/2014/01/2013-CISCRP-Study-Study-Participant-Experiences.pdf on September 16, 2014.
Centers for Medicare & Medicaid Services. Clinical research studies. Accessed at www.medicare.gov/coverage/clinical-research-studies.html on September 17, 2014.
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 23, 2014.
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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.
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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 23, 2014.
Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials, 4th ed. 2010. New York, NY: Springer Science + Business Media, LLC.
Getz K, Borfitz D. Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston, Mass: CenterWatch; 2002.
Medscape Oncology. Marshall JL. Why Are Only 3% of US Cancer Patients in Clinical Trials? 01/17/2013. Accessed at www.medscape.com/viewarticle/777662 on September 16, 2014.
National Cancer Institute. Children’s Assent to Clinical Trial Participation. Accessed at www.cancer.gov/clinicaltrials/learningabout/patientsafety/childrensassent on September 24, 2014.
National Cancer Institute. Learning About Clinical Trials. Accessed at www.cancer.gov/clinicaltrials on September 21, 2014.
National Cancer Institute. Patient Safety in Clinical Trials. Accessed at www.cancer.gov/clinicaltrials/learningabout/patientsafety on September 23, 2014.
National Cancer Institute. New Approaches to Cancer Drug Development and Clinical Trials: Questions and Answers. (2007) Accessed at www.cancer.gov/newscenter/pressreleases/PhaseZeroNExTQandA/print?page=&keyword= on September 23, 2014.
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 16, 2014.
US Department of Health and Human Services. Medicare & Clinical Research Studies. September 2012. Accessed at www.medicare.gov/Publications/Pubs/pdf/02226.pdf on September 23, 2014.
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 23, 2014.
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: 09/25/2014
Last Revised: 10/31/2014