Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
In the United States, an independent committee of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that the risks are small and are worth the potential benefits.
National Institutes of Health
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Clinical Trials
(Patient Education Institute) - Requires Flash Player - http://www.nlm.nih.gov/medlineplus/tutorials/cancerclinicaltrials/htm/index.htm
Also available in Spanish http://www.nlm.nih.gov/medlineplus/spanish/tutorials/cancerclinicaltrialsspanish/htm/index.htm -
Clinical Trials: Questions and Answers
(National Cancer Institute) - http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials
Also available in Spanish http://www.cancer.gov/espanol/cancer/hojas-informativas/estudios-clinicos-respuestas -
Introduction to Clinical Trials(National Institutes of Health) - http://clinicaltrials.gov/ct2/info/understand
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About Clinical Trials(National Institute of Child Health and Human Development) - http://www.nichd.nih.gov/health/clinicalresearch/aboutclinicaltrials.cfm
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Clinical Research Volunteer Program for Healthy Volunteers at the National Institutes of Health(National Institutes of Health, Clinical Center) - http://www.cc.nih.gov/participate/studies/healthy_vol_prg.shtml
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Clinical Trials(Food and Drug Administration) - http://www.fda.gov/womens/getthefacts/trials.html
Also available in Spanish http://www.fda.gov/womens/getthefacts/Spanish/trials-Spanish.html
- Clinical Trials: A Chance to Try Evolving Therapies(Mayo Foundation for Medical Education and Research) - http://www.mayoclinic.com/print/clinical-trials/DI00033/METHOD=print
- Clinical Trials: What You Need to Know(American Cancer Society) - http://www.cancer.org/docroot/ETO/content/ETO_6_3_Clinical_Trials_-_Patient_Participation.asp
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ClinicalTrials.gov(National Institutes of Health) - http://clinicaltrials.gov/
- JAMA Patient Page: Participating in Medical Research Studies(American Medical Association) - Links to PDF - http://jama.ama-assn.org/cgi/reprint/285/5/686.pdf
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What Is a Clinical Trial?(Texas Heart Institute) - http://www.texasheartinstitute.org/HIC/Topics/FAQ/clinical_trials.cfm
Also available in Spanish http://www.texasheartinstitute.org/HIC/Topics_Esp/FAQ/clinical_trials_span.cfm
- Alzheimer's Treatment Trials May Have Special Challenges(07/28/2008, HealthDay) - http://www.nlm.nih.gov/medlineplus/news/fullstory_67454.html
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JAMA Patient Page: Randomized Controlled Trials(American Medical Association) - http://jama.ama-assn.org/cgi/reprint/295/23/2812.pdf
Also available in Spanish http://jama.ama-assn.org/cgi/data/294/17/2262/DC1/1
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Participate in Clinical Studies at the NIH Clinical Center(National Institutes of Health, Clinical Center) - http://www.cc.nih.gov/participate.shtml
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Taking Part in Cancer Treatment Research Studies(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/Taking-Part-in-Cancer-Treatment-Research-Studies
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Access to Investigational Drugs: Questions and Answers(National Cancer Institute) - http://www.cancer.gov/cancertopics/factsheet/Therapy/investigational-drug-access
- Becoming a Research Volunteer: It's Your Decision(Office for Human Research Protections) - Links to PDF - http://www.hhs.gov/ohrp/outreach/documents/3panelfinal.pdf
- From Test Tube to Patient: Protecting America's Health through Human Drugs(Food and Drug Administration) - http://www.fda.gov/fdac/special/testTubeToPatient/default.htm
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Guide to Understanding Informed Consent(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/AGuidetoUnderstandingInformedConsent/Page2
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How Is a Clinical Trial Planned and Carried Out?(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/learning/how-trials-are-done
- Minority Role in Clinical Trials(Dept. of Health and Human Services, Office of Minority Health) - http://www.omhrc.gov/templates/content.aspx?ID=5147&lvl=2&lvlID=113
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Monitoring the Safety of Clinical Trials(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/understanding/monitoring-safety-of-trials
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National Institutes of Health Clinical Alerts and Advisories(National Library of Medicine) - http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html
- Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness(ECRI Institute) - http://www.ecri.org/Patients/References/Pages/Clinical_Trials_Patient_Reference_Guide.aspx
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Understanding Risk: What Do Those Headlines Really Mean?(National Institutes of Health) - http://www.nih.gov/news/WordonHealth/apr2004/risk.htm
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Understanding Screening Trials(National Cancer Institute) - http://www.cancer.gov/clinical_trials/doc.aspx?viewid=95E7FD10-A175-4A38-A0A8-AAF0CB5D521A
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Clinical Trials(Patient Education Institute) - Requires Flash Player - http://www.nlm.nih.gov/medlineplus/tutorials/cancerclinicaltrials/htm/index.htm
Also available in Spanish http://www.nlm.nih.gov/medlineplus/spanish/tutorials/cancerclinicaltrialsspanish/htm/index.htm
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Participating in Clinical Trials
(National Library of Medicine) - http://nihseniorhealth.gov/participatinginclinicaltrials/toc.html
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Children and Clinical Studies(National Heart, Lung, and Blood Institute, National Marfan Foundation, National Center for Research Resources) - http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php
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Clinical Trials and Insurance Coverage - A Resource Guide(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/understanding/insurance-coverage
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ClinicalTrials.gov: Search Clinical Trials(National Institutes of Health) - http://clinicaltrials.gov/ct/screen/SimpleSearch
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Communication, Relationships Key to Minority Community Clinical Trial Participation(National Institute of Arthritis and Musculoskeletal and Skin Diseases) - http://www.niams.nih.gov/News_and_Events/Spotlight_on_Research/2006/trial_participation.asp
- Placebo Effect(American Academy of Neurology) - http://www.neurology.org/cgi/content/full/71/9/e25
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Research into What Works Best(National Institutes of Health) - Links to PDF - http://www.nih.gov/about/researchresultsforthepublic/whatworks.pdf
- Study Examines Success Rates of Phase III Clinical Trials(American Cancer Society) - http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Study_Examines_Success_Rates_of_NCI-Sponsored_Phase_III_Clinical_Trials.asp
References and abstracts from MEDLINE/PubMed (National Library of Medicine)
- Article: Finding the right depression medication. STAR*D and other studies provide... - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=18724435&tool=MedlinePlus
- Article: Enhancing participation of older women in surgical trials. - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=18722933&tool=MedlinePlus
- Article: Thompson J, Petrie DA, Ackroyd-Stolarz S, Bardua DJ Out-of-hospital continuous... - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=18722248&tool=MedlinePlus
- Clinical Trials -- see more articles - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&term=clinical+trials[majr]+AND+humans[mh]+AND+english[la]+AND+(review[pt]+OR+guideline[pt]+OR+jsubsetk[text]+OR+jsubsetaim[text]+OR+jsubsetn[text]+OR+patient+education+handout[pt]+NOT+(clinical+trial[pt]+OR+letter[pt]+OR+editorial[pt]+OR+case+reports[pt]))&doptcmdl=summary&cmd_current=Limits&pmfilter_EDatLimit=last+1+Year&tool=MedlinePlus
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Glossary of Clinical Trials Terms(National Institutes of Health) - http://clinicaltrials.gov/ct2/info/glossary
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Links to General Information on Clinical Trials(National Institutes of Health) - http://clinicaltrials.gov/ct/info/links
- Where to Find Research Studies That Are Currently Enrolling Participants(Office for Human Research Protections) - http://www.hhs.gov/ohrp/outreach/researchlist.html
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National Institutes of Health - http://www.nih.gov/
- Medicare and Clinical Research Studies(Centers for Medicare & Medicaid Services) - Links to PDF - http://www.medicare.gov/Publications/Pubs/pdf/02226.pdf
- Medicare Clinical Trial Policies(Centers for Medicare & Medicaid Services) - http://www.cms.hhs.gov/ClinicalTrialPolicies/
- Reporting Complaints Related to FDA-Regulated Clinical Trials(Food and Drug Administration) - http://www.fda.gov/oc/gcp/complaints.html
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States That Require Health Plans to Cover Patient Care Costs in Clinical Trials(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-costs
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Children and Clinical Studies
(National Heart, Lung, and Blood Institute, National Marfan Foundation, National Center for Research Resources) - http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php
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Children's Assent to Clinical Trial Participation(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/understanding/childrensassent0101
- Should Your Child Be in a Clinical Trial?(Food and Drug Administration) - http://www.fda.gov/consumer/updates/pediatrictrial101507.html
- Women's Participation in Clinical Trials(Food and Drug Administration) - http://www.fda.gov/womens/trials.html
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Participating in Clinical Trials(National Library of Medicine) - http://nihseniorhealth.gov/participatinginclinicaltrials/toc.html
- Understanding Medical Research - http://www.nlm.nih.gov/medlineplus/understandingmedicalresearch.html
- Personal Health Issues - http://www.nlm.nih.gov/medlineplus/personalhealthissues.html