- What is a research study?
- Why is it necessary to do clinical research studies in children?
- Why should I consider enrolling my child in a research study?
- How is the safety of the participants protected?
- How do I find out if my child can be included in a research study?
- Where are the research studies conducted?
What is a research study?
Enrollment in a research study provides volunteers with investigational products (drugs). The treatment is provided by qualified physicians and research staff. Every study must follow strict guidelines under the Food and Drug Administration (FDA). The main purpose of a research study is to evaluate potential new treatments for a specific disease. All studies are carefully researched before a drug is given to a patient.
At Dayton Children's, the majority of clinical trials are Phase II through IV trials, which means that the drugs being tested have already been through extensive testing and are considered very safe. In most cases, the drug has already been tested and approved for use in adults before any study with children.
Why is it necessary to do clinical research studies in children?
Most of the medications now available for children do not have adequate pediatric dosing instructions on the labeling. This is because past medical research has primarily focused on adults. Children, however, are not miniature adults.
Drugs may work differently in children than in adults. Children may need more medicine or they may need less medicine or the medicine might not work in kids very well at all.
Carefully conducted clinical research studies are the best way to get the information that will help doctors have the best possible choices in medicines and treatments for children.
In 1997, Congress passed the FDA Modernization Act, which encourages research studies on children during the drug development process.
Why should I consider enrolling my child in a clinical research study?
Some reasons include:
- Clinical research studies often include no-cost diagnostic testing, such as blood tests and x-rays, that might not be done otherwise.
- Participants receive free physical examinations and may receive free study medications.
- Parents of a child with a chronic disease may want to help improve the care for children with that disease.
- Clinical research staff members are often able to spend more one-on-one time with their patients.
- Parents often feel they receive more personalized care and education.
- Participants may receive investigational research medication before it's available to everyone.
How is the safety of the participants protected?
The health and safety of children is our number-one priority. Clinical research is federally regulated with built-in safeguards to protect the participants. The clinical research studies follow carefully controlled protocols, which are reviewed by an Institutional Review Board (IRB). An Institutional Review Board is an independent group of medical, scientific and nonscientific members, whose responsibility is to ensure the protection and safety of the participants involved in a trial. These study plans detail what researchers will do in the study. In addition, the ethical and legal codes that govern medical practice also apply to clinical research studies.
How do I find out if my child can be included in a clinical research study?
If a study is being conducted in the specialty area at Dayton Children's where your child is treated -- nephrology, for example -- you may receive information about the study from that department. If you visit your child's primary care physician and his or her office is participating in a study, the office staff may provide you with information about the study.
Where are the clinical research studies conducted?
Many of the studies will be conducted at Dayton Children's Hospital, which is conveniently located on Valley Street, just off Route 4. Other studies are conducted in participating community physician offices.
Terms you should know
- Double-Blind: In double-blind clinical trial treatment periods, neither the patient nor the physician knows whether the active investigational medication or the placebo is being administered.
- Phase 1: Clinical trials with a small number of healthy volunteers that are generally conducted to determine safety and the investigational medication's action in the body.
- Phase 2: Clinical trials with a moderate amount of volunteers with the condition intended for treatment to determine both safety and effectiveness of the investigational medication.
- Phase 3: Clinical trials with a larger amount of volunteers with the condition intended for treatment and help determine safety and effectiveness of the investigational medication. Drugs can be approved after completing Phase 3 trials.
- Phase 4: Clinical trials occurring usually after a drug is approved to study new uses for a drug, compare the approved drug with other treatments, or study its long-term effects.
- Placebo: A placebo is a pill, liquid, or powder that contains no medicine. In clinical trials, investigational medications are often compared with placebos to assess the treatment's effectiveness.
For more information on PCTI - Dayton or clinical research at Dayton Children's, call 937-641-4294.
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