Dear Special Parent,
Clinical trials are research studies that explore new medical treatments, interventions, or tests to prevent, detect, treat, or manage various health conditions. For parents of children with developmental disabilities or chronic health conditions, clinical trials can offer access to cutting-edge therapies and contribute to advancing medical knowledge. However, finding and navigating clinical trials can be complex and daunting. In this article, I'll explore the steps to find clinical trials for your child, understand their benefits and risks, and provide tips on how to make informed decisions.
What Are Clinical Trials?
Clinical trials are conducted in phases to evaluate the safety, efficacy, and side effects of new treatments or interventions. The phases include:
Phase I
Tests the safety and dosage of a new treatment in a small group of participants.
Phase II
Evaluates the efficacy and further assesses safety in a larger group.
Phase III
Confirms efficacy, monitors side effects, and compares the new treatment to standard treatments in a larger population.
Phase IV
Conducted after a treatment is approved, to monitor long-term effects and gather additional information.
Benefits of Clinical Trials
Access to New Treatments
Participation can provide early access to new therapies not yet available to the public.
Expert Medical Care
Participants receive close monitoring and care from medical professionals and researchers.
Contributing to Research
Participation helps advance medical knowledge and may benefit future patients with similar conditions.
Risks of Clinical Trials
Unknown Side Effects
New treatments may have unknown or unforeseen side effects.
Ineffectiveness
The new treatment may not be more effective than the standard treatment.
Commitment
Participation often requires frequent visits, tests, and adherence to strict protocols.
Steps to Find Clinical Trials
Finding the right clinical trial for your child involves several steps:
1. Identify Your Child’s Needs
Start by understanding your child’s medical condition, current treatments, and any specific needs or goals you have for participating in a clinical trial. Discuss these with your child’s healthcare providers to get their input and recommendations.
2. Search for Clinical Trials
There are several resources to help you find clinical trials:
ClinicalTrials.gov:
This is a comprehensive database of privately and publicly funded clinical studies conducted worldwide. You can search by condition, location, phase, and other criteria. Visit ClinicalTrials.gov to begin your search.
National Institutes of Health (NIH):
The NIH provides information on clinical trials funded by the federal government and other entities. Their website includes resources for understanding and finding clinical trials. Visit the NIH Clinical Research Trials and You website for more information.
Patient Advocacy Organizations:
Many organizations provide information about clinical trials specific to certain conditions. Examples include Autism Speaks, the Rett Syndrome Research Trust, and the Muscular Dystrophy Association.
3. Evaluate Clinical Trials
Once you find potential trials, evaluate them to determine if they are a good fit for your child:
Eligibility Criteria:
Review the inclusion and exclusion criteria to see if your child qualifies. These criteria are designed to ensure the safety of participants and the integrity of the study.
Study Details:
Understand the purpose, duration, procedures, and what will be required of your child during the trial. Consider the frequency of visits, types of tests, and any potential disruptions to your child’s routine.
Potential Benefits and Risks:
Assess the potential benefits of the new treatment and weigh them against the risks and inconveniences. Discuss these with your child’s healthcare provider to get their perspective.
4. Contact the Study Team
If you find a trial that seems suitable, contact the study team to ask questions and express your interest. Prepare a list of questions to ask, such as:
1. What is the main goal of the study? What are the potential benefits and risks?
2. What treatments or interventions will be used?
3. What is the duration of the study?
4. How will participation impact my child’s current treatment plan?
5. What are the logistics of participation (e.g., location, frequency of visits)?
5. Informed Consent Process
Before your child can participate in a clinical trial, you will need to go through the informed consent process. This involves:
Receiving Information:
The study team will provide detailed information about the trial, including its purpose, procedures, risks, benefits, and your rights as a participant.
Understanding the Information:
Ensure you understand all aspects of the trial. Don’t hesitate to ask questions and seek clarification on any points that are unclear.
Voluntary Consent:
If you decide to proceed, you will sign a consent form indicating your voluntary agreement for your child to participate. Your child may also need to provide assent, depending on their age and ability to understand.
Tips for Navigating Clinical Trials
Stay Informed:
Keep yourself updated on new developments in your child’s condition and available clinical trials. Join patient advocacy groups and subscribe to relevant newsletters.
Advocate for Your Child:
Be proactive in seeking information and advocating for your child’s best interests. Ensure their needs and well-being are prioritized throughout the process.
Monitor and Communicate:
Maintain open communication with the study team and your child’s healthcare providers. Monitor your child’s response to the treatment and report any concerns promptly.
Be Prepared for Challenges:
Participation in a clinical trial can be demanding. Prepare for the logistical and emotional challenges that may arise and seek support from family, friends, or support groups.
Finding and participating in clinical trials can offer valuable opportunities for your child, but it requires careful consideration and planning. By understanding your child’s needs, conducting thorough research, and evaluating potential trials, you can make informed decisions that best support your child’s health and well-being. Remember, you are not alone in this journey. Utilize available resources and seek support from healthcare providers, advocacy organizations, and fellow parents.
Dr. Kimberly
Sign up!
#SpecialParenting Newsletter
Exclusive resources & tips in your inbox to empower your special parenting journey.
Dr. Kimberly Idoko
Certified Special Parent Coach
Dr. Kimberly is the mother and fierce advocate of Aiden and Lexi; Lexi is developmentally disabled by Rett Syndrome. Dr. Kimberly is a board-certified neurologist in clinical practice for more than 15 years; she is also a children’s rights attorney — the former director of healthcare advocacy at a Los Angeles-based legal agency. She is Yale College, Penn Medicine, Columbia Business, and Stanford Law trained.
