WHAT       WHY      WHO    WHERE and WHEN

Community Health Care does participate in clinical trials at any given time, for eligible patients that would choose to participate. Please read the following information to see if you would be interested in benefiting from a clinical trial. 

• Interventional  trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
• Observational  trials address health issues in large groups of people or populations in natural settings.

WHY participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

WHO can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. 

• The factors that allow someone to participate in a clinical trial are called "inclusion criteria". 
• The factors that disallow someone from participating are called "exclusion criteria". 

These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Should you participate in clinical research?

People participate in clinical research for a variety of reasons. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free.

The patient's rights and safety are protected in two important ways: 

• First, any physician awarded a research grant by a pharmaceutical company or the NIH must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. 
• Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.

Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.

Other questions to ask include:

• How long will the trial last?
• Where is the trial being conducted?
• What treatments will be used and how?
• What is the main purpose of the trial?
• How will patient safety be monitored?
• Are there any risks involved?
• What are the possible benefits?
• What are the alternative treatments besides the one being tested in the trial?
• What happens if I am harmed by the trial?
• Can I opt to remain on this treatment, even after termination of the trial?

The above information was obtained from: http://clinicaltrials.gov/

WHERE and WHEN:

If you would be interested in participating in a study, or would like to know more, click here to send an email , or call our office at 330-854-4574 and ask for Tammy Lincoln. We are currently looking for adult patients who have diabetes, acute anxiety, older patients with normal cholesterols, patients with elevated lipids (cholesterol) or patients with muscle spasms in their lower backs. We are also looking for adolescents (at least 13 years old) and adults with sore throats or tonsillitis.  We join new studies on a regular basis, so even if you don't have one of these diagnoses, contact us and we may be able to match you with a study that would meet your needs.
 

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