Clinical Drug Trials Increasingly More Available for Individuals with Autism
The US Food and Drug Administration has approved two medicines for treating one symptom of autism spectrum disorders (irritability) but the agency has not yet approved a drug that treats any of autism’s three core symptoms – communication difficulties, social challenges, and repetitive behavior. The good news is that there are medications currently in clinical trials, and if you or your child has autism, you may be a candidate to participate and help increase the options to other families across the nation.
Autism Speaks notes that while 90% of children with cancer are enrolled in clinical trials, only 5% of children with autism are. Participation can make a difference in the lives of all who struggle with an autism spectrum disorder. Of course, joining a clinical trial is a personal and important decision, so you want to be sure to have as much information as you can before you opt in or out. Autism Speaks has created The Participant’s Guide to Autism Drug Research to answer common questions you may have.
First, what exactly is clinical drug research? Clinical trials involve human volunteers but only after considerable tissue and/or animal research have been completed to gather preliminary evidence on safety and effectiveness. The National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) both have strict rules when it comes to drug trial safety. In the case of autism, where the volunteer is most likely a child, both parental consent and the child’s assent (agreement) are needed to continue with the research.
The Participant’s Guide to Autism Drug Research also explains the different phases (one through four) that clinical trials go through, each of which has a different primary purpose.
Second, why would you want to participate in a drug trial? After all, you are taking some risk being one of the first to try a new drug. Remember that the drugs are only advanced to human studies after there is reasonable evidence that they are safe. Also, consider two positives – you could find relief of symptoms for yourself plus be advancing research so that other families benefit in the future as well.
Autism Speaks does remind potential drug trial participants that enrolling in clinical research is not the same as seeing a personal physician. For example, you may be assigned to the “placebo” group, where you or your child will not receive an active drug. Also, the trial is geared toward advancing scientific research. The treatment is not focused on your own personal needs. There is also the commitment to procedures such as blood tests and imaging scans that are necessary for a trial, but not necessary for your personal care.
On the positive side, clinical trials often cover the medical costs and other costs associated with participation whereas with a personal physician you bear some of these costs yourself.
If you do choose to participate in autism drug research, keep a list of questions to ask those conducting the trial. These include an explanation of the research to date on the drug, the side effects, and how participation might affect daily life. Also, understand your rights as a trial participant. You have the right to a clear explanation of all risks and benefits, how the study will be carried out and any anticipated costs you might incur. Remember that you have the right to leave the study at any time if you feel that it is not meeting your needs.
The entire Participant’s Guide is available on the Autism Speaks website. Autism Speaks is dedicated to improving the lives of all who struggle with autism. They pledge that as more potentially helpful medications enter the research “pipeline,” they will continue to work with families and recognized experts to ensure the safety, well-being, and best possible outcomes for study participants.
Autism Speaks also has a database to research the currently available clinical trial options through the Autism Clinical Trials Network (ACTN), a collaboration of treatment and research centers across the nation.
Source: Autism Speaks