Issue 38.14
What is a clinical study? A clinical study is a carefully controlled scientific investigation which looks at promising medications, treatments or devices to see if they are safe and effective. Each study aims to answer specific scientific questions and to find better ways to prevent, diagnose or treat certain condition.¹
Who can participate? Some studies involve people with a certain disease, others target healthy volunteers. Each study has a specific set of criteria which are used to identify appropriate participants, for example, age, gender, current treatment and medical condition.¹
Am I or my insurance company billed for participating in a study? You or your insurance company is not billed participating in a clinical trial.
How do I take part in studies? You might see an advertisement recruiting for a clinical study or your doctor might suggest a particular study relevant to you. You can volunteer for studies if you meet the criteria. Then the doctor or researcher conducting the study must determine if you are eligible for that particular study. The study doctor must provide you with both verbal and written information about the study including details about possible risks and benefits. This is to ensure that you understand the key facts before deciding whether or not to participate.¹
What is an Informed Consent? This document you must read and sign to confirm your decision to take part in a given study. This document IS NOT a contract and you may withdraw from a study at any time.
What are benefits of participating? There are several potential benefits of taking part in clinical trials: take on a more active role in your own healthcare; gain access to new treatments before they are widely available; get expert medical care at leading healthcare facilities; help others by contributing to medical research.
What are the Risks? Clinical studies can only take place after satisfactory information has been gathered on the safety of the medication. However, there are still potential risks: New products may have side effects or risks unknown to the doctors; new products may prove to be ineffective or less effective than current treatments; study may require more of your time and attention than normal treatments.
Do you get paid? Most studies do compensate for your time and travel. This is covered in the informed consent you sign prior to beginning a study.
How is your safety protected? The health and safety of participants is the first priority of any clinical study. Thus research teams must follow strict ethical and scientific principles and all studies must be approved by the authorities.
During a study, you will have ongoing appointments with a doctor/research team and access to expert medical care and leading healthcare facilities. This enables you to act immediately if you are concerned about any side effects.
What happens during a clinical study? The clinical study process depends on the type of the study being conducted and will be explained to you by the study team. Participation can vary from weekly visits for several months to simply one or two visits. It depends on the study. Sometimes the research team will also call you between visits.
Can you leave a clinical study after it has begun? Participation in a clinical study is always voluntary. A participant who wishes to withdraw can do so at any time, although is advisable to discuss your decision with a member of the research team.
Currently enrolling studies being conducted in our area:
* Type 2 diabetes, ages 18 and older
* Chronic constipation with no known cause, age 18 and older
* Persistent asthma ages 12 and older
* Ear infections ages 6 months and up
* Ear infections for children with tubes in their ears ages 6 months to 12 years
For more information on clinical studies or if you are interested in the above-mentioned clinical trial contact: CHRYSALIS CLINICAL RESEARCH 435-656-1704.
1. Clinicaltrials.gov website. Understanding clinical trials. Available at URL: http://www.clinicaltrials.gove/ct2/info/understand – last access date 21 August2012