Clinical Trials and Studies
Here are some clinical studies of interest to those with functional GI or motility disorders:
What are Clinical Studies or Trials
A clinical study or clinical trial (they mean the same thing) is a research study to answer specific questions about new products, therapies, or new ways of using known treatments. Through these research studies, investigators find new and better ways to treat, control, prevent, diagnose, or detect conditions, or to improve the quality of life for those with an illness.
A study may be limited to questionaire designed, for example, to help doctors understand the needs of patients with a particular disorder. Other studies look at the effectiveness of counseling or psychological treatment.
A treatment could be a drug; medical device; or biologic, such as a vaccine, blood product, or gene therapy. Possible treatments with potential toxicity must be studied in laboratory animals first before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. Clinical treatment studies/trials test potential therapies in people who volunteer to see if they should be approved for wider use in the general population.
What are Phases
Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed.
Are there Risks
Although efforts are made to control risks to clinical trial participants, some risk may be unavoidable because of the uncertainty inherent in clinical research involving new medical products. It's important, therefore, that people make their decision to participate in a clinical trial only after they have a full understanding of the entire process and the risks that may be involved.
Who are the Sponsors
Clinical studies/trials are sponsored or funded by a variety of organizations or individuals. Many studies are sponsored by the National Institutes of Health (NIH), or are industry sponsored by pharmaceutical companies or makers of medical devices. They may also be sponsored by physicians, medical institutions, foundations, voluntary groups, or other government agencies. Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
List a Study
If you are a medical society, governmental agency, educational or research institution, or a nonprofit organization we invite you to contact us about listing your study or trial. Go »
We suggest you take a moment to read this article from IFFGD, Guide to Randomized Clinical Trials
"Until the mid-twentieth century, all treatment was empirical. Healers relied upon their collective and individual experience to select the best remedy for a patient's complaint. Even today, most treatments are trial and error. Physicians, almost unique among healers, have sought scientific bases for their treatments, and their most powerful tool is the randomized clinical trial (RCT) . . ." (More)
More on Finding Clinical Trials
The Web site ClinicalTrials.gov is one source that provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The NIH, through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA.
Sources and Suggested Reading
- National Institutes of Health (NIH). An Introduction to Clinical Trials, http://clinicaltrials.gov/ct/info/whatis, (Accessed May 29, 2004)
- FDA. "Inside Clinical Trials," FDA Consumer Magazine, http://www.fda.gov/fdac/features/2003/503_trial.html, (Access May 29, 2004)