Clinical Research Unit – We’re here to help!

Published by: michadmin on January 25th, 2012

 MICHs’ Clinical Research Unit (CRU) has a team of skilled professionals available to provide assistance to researchers with all aspects of a trial. This includes but is not limited to submissions, consent development, nursing/research assistant support as well as full project management. 

Did you know that, the MICH CRU provides assistance to MICH members for Ethics/Institutional Submissions? The cost of services for grant funded study submissions can be tailored to your budget.

 

Why Clinical Trials in Children are Important

Clinical trials yield important information on a medical product’s safety, dosing, and effectiveness, which is the basis for Federal approval and product labeling. Health care providers use labeling information to prescribe the right product for their patients and to monitor them for potential side effects. This includes prescribing the right drug at the right dose.

Historically, only 20–30% of drugs approved have been labeled for use in children. So, by necessity, doctors routinely give drugs to children off label.” We need to do clinical trials in children so that a child will not be an experiment of one every time a doctor prescribes a drug,” says Dianne Murphy, M.D., Director of the Office of Pediatric Therapeutics at the Food and Drug Administration (FDA). (www.fda.gov)

 

How Children Can Help Advance Medical Knowledge

Children participate in clinical research for many reasons—some to help themselves, some to help others, and some just want to be involved in engaging and exciting new research.  Regardless of their primary reason for joining clinical trials, the result is clear—by participating in clinical research, children can help:

• Learn more about diseases and ways to prevent them
• Find out how research is conducted with children as Healthy Volunteers
• Understand the differences in children as they grow
• Help others—young and old—in the future
• Enhance their lives and become healthier adults

 

For more information about the Clinical Research Unit and their services, contact:

Harriet Simpson, Clinical Research Unit Administrative Coordinator
hsimpson@mich.ca
Ph: (204) 480-1348
Fax: (204) 789-3907

 

Current MICH Clinical Trial – “Baby Teeth Talk Study”

The project aims to improve the dental health of Aboriginal children by working with their mothers from the time they are pregnant. The project hopes to result in an improvement in the dental health (less tooth decay) of young Aboriginal children in Canada.  Early Childhood Caries (ECC) is defined as “the presence of one or more decayed, missing (due to caries), filled tooth surface in any primary tooth in a child 71 months of age or younger”. Approximately 50 to 90 percent of children in some Aboriginal communities will end up developing ECC in their early years.

This project also aims to help develop parents’ understanding about the health of their child’s teeth, mouth and gums and build their confidence in managing their own oral health and that of their families.

You are invited to participate in the study if you are: Pregnant (beginning second trimester), Self-identify as First Nations, Métis or Inuit, 16 years of age or older and live in the Winnipeg area.

Participants will receive; gift card honorarium, dental checkup and basic dental care at no charge, toothbrushes and toothpaste, fluoride varnish treatments for your baby at no charge and dental checkups for your child at ages 2 and 3 years at no charge.

Dr. Bob Schroth (Early Childhood Oral Health) is currently recruiting for the Baby Teeth Talk Study!
Contact Shauna McGregor by phone at (204) 789-3346 or email babyteethtalk@mich.ca

Watch the December Small Wonders story for more information!
http://bit.ly/ghky0l