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) - 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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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
- Understanding Clinical Trials(National Institutes of Health) - http://clinicaltrials.gov/ct2/info/understand
- 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 Trials(Food and Drug Administration, Office of Women's Health) - 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
- 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
- Program for Healthy Volunteers(National Institutes of Health, Clinical Center) - http://www.cc.nih.gov/participate/studies/healthy_vol_prg.shtml
- 'Phase 0' Trials Aim to Speed Cancer Drug Development(04/17/2009, HealthDay) - http://www.nlm.nih.gov/medlineplus/news/fullstory_83052.html
- FDA 101: Clinical Trials and Institutional Review Boards(04/14/2009, Food and Drug Administration) - http://www.fda.gov/consumer/updates/clinicaltrials041409.html
- FDA Imposes Restrictions on Coast IRB Due to Violations(04/14/2009, Food and Drug Administration) - http://www.fda.gov/bbs/topics/NEWS/2009/NEW01996.html
- Weak Evidence Backs Most Heart Guidelines, Report Finds(02/25/2009, HealthDay) - http://www.nlm.nih.gov/medlineplus/news/fullstory_80997.html
- Many Clinical Trials Moving Overseas(02/18/2009, HealthDay) - http://www.nlm.nih.gov/medlineplus/news/fullstory_80690.html
- 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
- How Is a Clinical Trial Planned and Carried Out?(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/learning/how-trials-are-done
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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
- Monitoring the Safety of Clinical Trials(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/understanding/monitoring-safety-of-trials
- Participate in Clinical Studies at the NIH Clinical Center(National Institutes of Health, Clinical Center) - http://www.cc.nih.gov/participate.shtml
- Guide to Understanding Informed Consent(National Cancer Institute) - http://www.cancer.gov/clinicaltrials/AGuidetoUnderstandingInformedConsent/Page2
- 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
- National Institutes of Health Clinical Alerts and Advisories(National Library of Medicine) - http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html
- Understanding Risk: What Do Those Headlines Really Mean?(National Institutes of Health) - http://www.niapublications.org/tipsheets/risk.asp
- 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) - 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
- 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
Also available in Spanish http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php?language=es
- Placebo Effect(American Academy of Neurology) - http://www.neurology.org/cgi/content/full/71/9/e25
- 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
- Article: How well does blinding work in randomized controlled trials?: a... - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=19381149&tool=MedlinePlus
- Article: Studies should be controlled, randomized, and blinded. - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=19381148&tool=MedlinePlus
- Article: Payment of trial participants can be ethically sound: moving past... - http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=19374064&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
- Glossary of Clinical Trials Terms(National Institutes of Health) - http://clinicaltrials.gov/ct2/info/glossary
- ClinicalTrials.gov: Search Clinical Trials(National Institutes of Health) - http://clinicaltrials.gov/ct/screen/SimpleSearch
- Search the Studies(National Institutes of Health, Clinical Center) - http://clinicalstudies.info.nih.gov/
- 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
- 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
- Clinical Trials: A Crucial Key to Human Health Research - http://www.nlm.nih.gov/medlineplus/magazine/issues/summer06/articles/summer06pg4-5.html
- Clinical Trials: Key to Medical Progress - http://www.nlm.nih.gov/medlineplus/magazine/issues/summer08/articles/summer08pg4-5.html
- Value of Medical Research - http://www.nlm.nih.gov/medlineplus/magazine/issues/summer08/articles/summer08pg2-3.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
Also available in Spanish http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php?language=es
- 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
- 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