Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decisionmaking.
The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.
Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas.
If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed.
For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits.
A clinical trial may find that a new strategy, treatment, or device
- improves patient outcomes;
- offers no benefit; or
- causes unexpected harm
All of these results are important because they advance medical knowledge and help improve patient care.
Children and Clinical Studies: Messages for researchers11/04/2014
Children and Clinical Studies: For parents and caregivers11/04/2014
Children and Clinical Studies10/07/2014
Children have often had to accept medicines and treatments based on what is known to work in adults. The National Heart, Lung, and Blood Institute is eager to improve the evidence to ensure the safety and efficacy of therapies for all children. We have provided this video to help families and investigators make wise decisions. Learn more at http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php
This video was made possible by grants from the NHLBI, the National Marfan Foundation, and the NIH's National Center for Research Resources.