Help young adults overcome barriers to Huntington’s clinical trials
Taking time off work and finding child care are two such challenges
An encouraging number of clinical trials are currently recruiting, or soon will be, for people affected by Huntington’s disease (HD).
I recently wrote about the CAP score, a mathematical calculation that many HD clinical studies use to find participants who are at comparable points along their HD journey. To figure out your own CAP score, the two things you’ll need are your current age and your number of CAG repeats, which is broadly indicative of the severity of the Huntington’s-causing mutation.
Based on my observations, recruitment for trials has been slowly trending toward seeking participants with a lower CAP score, which has opened up trials to people who are a bit younger or have less severe disease (or both) compared with previous trials. In my opinion, a younger participant population in clinical trials would inevitably lead to new barriers for participation that we’ll need to figure out.
Trials are a big commitment
Participating in a clinical trial is not a cake walk. For many people with rare neurological conditions like Huntington’s disease, a trial may be their best shot at halting or slowing disease progression. But it’s a major commitment for the participant and most likely their family members or others who support them.
Taking part in a trial can last for many months, and sometimes even years. During that time, participants are routinely asked to visit clinical trial locations to be monitored and to complete tasks that help the trial team decipher if the experimental treatment might be working. Every clinical trial is different, but most require participants to visit monthly. Regardless of how far someone might be from a clinical trial location, a monthly commitment is nothing to downplay.
Younger patients without many symptoms have a handful of obstacles when it comes to giving up their time and pausing their day-to-day life to join a clinical trial. Two things that stand out to me as major barriers are finding care for younger children (and pets) and taking paid time off or otherwise dealing with an employer.
I haven’t come across a clinical trial in the HD community that doesn’t require a companion, care partner, or caregiver to accompany the participant during visits. If you’re married with children, I’d assume you’d want your spouse to go with you to your appointments. If you have to travel — sometimes overnight — for a study visit, it could mean spending anywhere from 12 to 24 days on the road per year. If you have young children or pets, where are you finding care for them?
I’ve never seen a clinical trial help offset the cost of child or pet care. Are the people creating these clinical trials thinking about the opportunity cost for participants? I hope so.
Taking time off work
In my view, most people don’t want their employer or their health insurance to know about Huntington’s disease. In the first nine months of HD Genetics, a new platform I helped create that helps those at risk for Huntington’s disease get genetic counseling and testing from the comfort of their homes, about half of our clients use a pseudonym so that an employer or insurance company won’t find out that HD is in their family.
If the people being recruited for clinical studies are still fully functional employees, how do they take 12 to 24 days off work to participate in a trial? That could be the entirety of someone’s paid time off for the year; say goodbye to vacation or sick days. If someone doesn’t receive paid time off, they might have to take them without pay, which, according to my calculations, could lead to a 5%-10% decrease in annual compensation. I know people are compensated for participating in clinical trials, but from my understanding, it’s not enough to make up for lost wages or paid time off.
This year I participated in an observational trial called HDClarity (NCT02855476). This trial involves no medication and is 100% voluntary. In January, I took two days off work and away from family to fly to Nashville, Tennessee, to visit a clinical trial site at Vanderbilt University Medical Center. I flew back in March for a short spinal tap appointment, but that was still a full day away from work and family. The study covered part of my travel costs, but as of this writing, I still haven’t received reimbursement.
Huntington’s disease is brutal, and I believe most people would participate in a clinical trial if the medicine could stop disease progression. But trials need to be more accessible and flexible for younger people who are working and caring for children. The faster trials meet their recruitment goals, the faster researchers can determine whether investigational medicines work or not.
We need clinical trials to continue to recruit younger patients, because an important goal is to one day find a treatment to stop symptoms before they start. We just have to make the trials feasible for those young participants.
I welcome anyone’s opinions, experiences, or additional ideas about participating in clinical trials. Please share in the comments below.
Note: Huntington’s Disease News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Huntington’s Disease News or its parent company, BioNews, and are intended to spark discussion about issues pertaining to Huntington’s disease.
Such a great post, BJ! I myself am dealing with this very issue. I am supposed to be traveling to Georgetown to participate in a clinical trial, but I'm having a hard time finding childcare for my 2 little kids (5yo and 3yo). They STRONGLY ENCOURAGE a support person come with you, but if I can't find childcare, then my husband will have to stay home to take care of the kids.
The other thing I'm running into is some studies/trials will help pay for travel expenses up front (which is so great), while others barely cover the full cost of a hotel stay and they reimburse you. This definitely limits my ability to participate in some good studies where more people are really needed.