Over the past several years, a large and growing number of people want to learn more about clinical research and how to participate in a study. This site provides information about the clinical trials process and what it means for you to volunteer to participate in a clinical trial.

Due to the numerous pharmaceutical discoveries in medicine, clinical research is allowing the public to participate in their programs. Many people are joining these clinical trials for a variety of reasons:

You may have a disease or illness for which there is no cure or treatment presently.

To get involved in the advancement of science, not only for medications but in therapies which may offer improved treatments and possibly even cures for life-threatening and chronical illnesses and diseases.

Many join to get optimum quality medical care which they could not obtain due to financial reasons and they may not have health insurance to get proper care.

Whatever reason(s) spark your interest, the links below are provided to inform you of the programs, the regulations etc, the application processes and much more to help you in making your decisions. If you do volunteer, it is important that you enter the clinical trial programs with as much information you can secure to make an informed choice.
What is a Clinical Trial?
A clinical trial is a carefully designed research program done with volunteers. The treatments are considered to be investigational and you are monitored and watched through very careful supervision consisting of physcicians, research professionals provided by the biotechnology and pharmaceutical companies. These companies have developed the drugs or procedures and they are very careful in choosing the right professional team of investigators to monitor you.

All clinical trials are reviewed by the U.S. government’s Food and Drug Administration (FDA) and of Institutional Review Boards (IRBs).

The IRBs are independent committees who make sure you are not put in an unneccessary risk situation. They are present to protect you and you are asked to sign a consent form before you participate in the trial.

Different study groups are formed to test different responses. Some of the volunteers are given placebos and some are given the treatment or drug that is being tested.

You are given complete physical examinations and your medical history is reviewed. Everything is explained so that you totally understand it. Testing can be continued if the individual shows progress.

When the research trials are completed, all information and research documentation are formulated and studied and hen they must meet the approval of the FDA.

CenterWatch.com is a company dedicated to providing patients with a variety of information services about clinical research. The company offers reports that patients, consumers and advocates can purchase. The reports inform you on specific illnesses and in depth information on the clinical trials being offered as well as new medical therapies.

http://www.centerwatch.com/main.htm

Register online to receive emails and updates of trials in the areas of diseases and illnesses that you are interested receiving updates and information on free of charge. This is a valuable asset if you are interested in keeping abreast of what is happening.

http://www.centerwatch.com/patemail.htm

ClinicalTrials.gov is a database provided by the National Institute of Health. (NIH) . The database provides detailed information regarding the purpose of the trial, their time span, their purpose, and the necessary qualifications or criteria the volunteer must present to participate in the research. They provide you with the names, addresses etc of the people you will need to contact. The database includes thousands of federally funded as well as private studies on a nationwide basis. To access the site. Click on these links:

http://www.fda.gov/ora/compliance_ref/bimo/

Clinical Trials.Com – http://www.clinicaltrials.com your source for comprehensive information for current clinical trials being conducted nationwide. Be sure to register for future study information with our Be Informed Registry. Community Resources – CLINICALTRIALS.COM has organized contact information for more than 20,000 health agencies and support groups across more than 1500 cities nationwide. You may search for local Community Health Resources by illness/condition or geographic location.

***IMPORTANT***

Please also check out this article by clicking on this link.

Government to Researchers: Follow the Rules — or Else Fines and other measures proposed to protect patients

© Copyright 2000 by Gail R. Mitchell

Author

  • Ms. Mitchell began her full-time caregiving experience in the early eighties when her husband was diagnosed with cancer. Later on she became the primary caregiver for her father, along with her mother who had become critically ill from burnout prior to her dad’s passing. In recent years, she cared for several friends with AIDS while continuing to care for her mother and actively providing support, information, referrals and resources for caregivers.

    Gail's leadership on the Internet and her success with Empowering Caregivers led her to found National Organization For Empowering Caregivers (NOFEC) INC in 2001.

    Prior to founding NOFEC, she created the iVillageHealth Chat: Empowering Caregivers, which she hosted for over 5 years. Within a month of hosting she created Empowering Caregivers: www.care-givers.com in 1999 as a resource for caregivers around the globe. Over three million visitors have frequented the website.

    She has presented at national and international care-related conferences and programs and has been a keynote speaker for many programs as well.

    Ms Mitchell has assisted thousands of caregivers online and offline in ways to empower themselves in their roles in caring for loved ones.

    For a list of clients and/or her resume, please contact info@care-givers.com

    Gail's articles have been published in many venues nationally and in Canada. Presently, she is a member of American Society on Aging and National Quality Caregivers Coalition.

    Gail has discovered that there is life after caregiving: She has become a successful ceramic artist and installation artist. She created Crystal Illumination Art to bring the transformative quality of illumination, light and color to the human experience and celebrate its ability to inspire, heal and nourish our physical, mental, emotional and spiritual well being.

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By Gail Mitchell