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Clinical trials are an integral part of new drug discovery. Their relevance in this respect has developed considerably during the last century. Today, before a new drug can be made available, evidence of its safety and effectiveness has to be provided by well-designed, well-controlled, and carefully monitored clinical studies in volunteer patients. This site gives information on the history of clinical trials from early times and answers questions on their design, complexity, and the built-in safety features intended to protect the patient volunteers.


History of Clinical Trials: How it All Began History of Clinical Trials: How it All Began
  Research methods, experimentation, and medicinal studies have their roots in a long history of drug discovery and primitive clinical trials. Remedies, once fruit juice and concoctions of oils and herbs, revolutionized an intriguing, though not new, area of therapeutic study that had involved humans since its earliest times. Modern progress has seen the creation of the Federal Drug Administration, Health Service Acts, and international health initiatives, which place an emphasis on patient protection. Click here

Drug Discovery and Clinical Trials Drug Discovery and Clinical Trials
  Drug and clinical research is the gateway to medical advances. Research identifies new methods most likely to succeed and shows how the drug may be used safely and effectively. Since the Second World War, clinical trials have matured into an approved procedure of four phases in the assessment of new drugs. Its features include the utilization of a control collection of patients, the random allocation of participants to the experimental or control group, and the application of various evaluations throughout the patient's stay. Click here

Recommended Questions to Ask About a Clinical Trial Recommended Questions to Ask About a Clinical Trial
  Here are some questions you should ask before you (or a dependent) embark on a clinical trial… Click here

Why Should I Participate in a Clinical Trial? Why Should I Participate in a Clinical Trial?
  People from all around the world volunteer to take part in clinical trials… Click here

What Are the Phases of Clinical Trials? What Are the Phases of Clinical Trials?
  In Phase I a small number of healthy volunteers are exposed to the research treatment… Click here

What Protection Do You Have as a Patient in a Clinical Trial? What Protection Do You Have as a Patient in a Clinical Trial?
  Clinical Trials are governed by the same legal and ethical codes that oversee medical practice… Click here

What Is Informed Consent? What Is Informed Consent?
  Informed consent is a critical element of a good clinical trial… Click here

Are There Risks or Side Effects in Clinical Trials? Are There Risks or Side Effects in Clinical Trials?
  Side effects may be particular to the patient… Click here

Can You Leave a Trial at Any Time? Can You Leave a Trial at Any Time?
  Your initial decision to become a volunteer does not erase your rights as an individual and your personal wishes… Click here

Resource Links Resource Links
 

Institutions and documents such as the FDA, the National Institute of Health, the Women's Health Initiative, and more are valuable sources of information and provide insight into a wide range of scientific and health topics. This site was made possible by the published efforts of the many researchers, scientists, professors and physicians who have graciously made their work and discoveries available to the public. See links below.

Food and Drug Administration (FDA)

Clinical Trials Search.org

National Institute on Aging

World Medical Association Policy: Declaration of Helsinki

Women's Health Initiative



 

This minisite created on : September 12th, 2002   
Last Update : July 15th, 2004   

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