ACRO believes that an uncompromising commitment to safety and quality is the hallmark of ethical research. ACRO members are committed to putting the safety of clinical research participants first.

ACRO strongly supports the efforts of organizations such as the Center for Information and Study on Clinical Research Participation (CISCRP) to better educate and inform the public, patients, medical/research communities, the media, and policy makers about clinical research participation and the role that each party plays as a participant in the process. ACRO is proud to be a member of the CISCRP Circle of Supporters.

CISCRP has provided the following useful information for patients and their families to help answer questions they may have regarding participation in a clinical trial.

What are clinical trials?

A clinical trial is a research study involving human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set by the protocol.

Why are clinical trials conducted?

Many clinical trials are done to see if a new drug or device id safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the "standard treatments." Sometimes, clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.

What are some of the possible benefits of my participation?

• Gain access to potentially new research treatments
  
• Receive expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
  
• Help others by contributing to medical research and treatment advances.

What are some of the possible risks of my participation?

• There may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.
  
• The treatment may not be effective.
  
• Participation in the trial may be demanding and time consuming.

Key Questions to Ask Before Participating in a Trial:

• What is the main purpose of this study?
  
• Does the study involve a placebo or a treatment that is already on the market?
  
• How will the treatment be given to me?
  
• How long is the study going to last and what will I be asked to do as a participant?
  
• What has been learned about the study treatment and are any study results published?
  
• Do I have to pay for any part of the study? Will my insurance cover these costs?
  
• Will I be able to see my own doctor?
  
• If the treatment works for me, can I keep using it after the study?
  
• Can anyone find out whether I'm participating in the clinical trial?
  
• Will I receive any follow-up care after the study has ended?
  
• What will happen to my medical care if I stop participating in the study?
  
• Ask yourself - Are you comfortable with the doctor and study staff as they will be medical care providers during the study?

For additional information on clinical trials, please visit www.ClinicalTrials.gov, a service of the National Institutes of Health (NIH).


The information featured on this page is provided by the Center for Information and Study on Clinical Research Participation (CISCRP). CISCRP is an independent nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research participation. CISCRP does not recruit patients for clinical trials nor do we conduct clinical trials.

To learn more about CISCRP, please go to http://www.ciscrp.org

For additional information on children and clinical trials, please visit http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php, a service of the National Heart Lung and Blood Institute.

No More Hand-Me-Downs: Research Designed for Children

A Website for Educating Parents, Their Children and Healthcare Providers about Pediatric Clinical Research

We all know that children are not "little adults" when it comes to treating their health problems. They need medications, devices and treatments designed especially for their unique medical conditions, not to mention their developing brains and bodies. Clinical research in children is the best way to determine which therapies are safe and effective for children, but all too often children must rely instead on hand-me-downs from adult clinical research.

A comprehensive new award-winning web-based educational tool can empower parents and children with the information they need to understand clinical research and make informed decisions about participating in a study. The site combines text, graphics, and videos of experts, parents, and children themselves sharing their personal experiences in pediatric clinical research.