We are surrounded by amazing breakthroughs in medicine every day. There are vaccines that can prevent diseases; there are new surgical techniques that allow operations to be performed through the smallest of incisions, as well as medicines that allow children with chronic illnesses to live healthier lives. While medicine has come a long way, there is still much more that needs to be done. One important way to advance medicine is through clinical research.
Clinical research can help us to understand how medications and therapies affect children. Many new drugs and medical devices go on the market without being tested among children. Despite the lack of research data for children, these therapies become widely used. The US government has offered incentives to manufacturers to conduct clinical trials with children for drugs and devices that have already been approved for adults. These clinical trials can determine whether drugs and treatments are both safe and effective for children.
For children with chronic illnesses, new therapies that are not yet on the market may offer more choices to manage their conditions. For example, new ways of delivering insulin to diabetic children, such as pumps and inhalant devices, were first tested in clinical trials to determine if they worked as well as injected insulin.
Connecticut Children's Medical Center has a Clinical Trials Unit that helps physicians, nurses and families participate in clinical research studies. The staff of the Clinical Trials Unit has more than 40 years combined experience conducting clinical research and understands the special needs of children and families.
Our physicians and Clinical Trials Unit staff work hand in hand with the assistance of study volunteers - incredible children and their families who are willing to participate in clinical studies that help determine if research ideas hold promise for better treatment, prevention and cures.
Volunteers can be of any age or gender. Studies need both healthy volunteers and children with a specific illness or inherited disorder. Volunteers have diverse cultural, ethnic and racial backgrounds.
To choose to participate in research is an important family decision. Whatever the reason to participate in a research study, each and every research volunteer and his or her family is instrumental in shaping the future of medicine.
Patients who are interested in volunteering to participate in research can learn more by reading Becoming a Research Volunteer: It’s Your Decision, created for research participants by the federal government, which outlines some of the factors to consider when deciding whether to participate in research.
For more information, please see "Frequently asked Questions for Families."
In addition, those considering volunteering for research can review the Belmont Report, which outlines the ethical considerations in research involving human subjects. The report was compiled by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979, and served as the framework for the federal regulations created to protect human subjects.
- Department of Health and Human Services Human Subject Protection Regulations
- Food and Drug Administration Human Subjects Protection Regulations
- Food and Drug Administration IRB Regulations