The topic today is Trial Partners. Sometimes we researchers refer to them as Study Partners or Informants, the latter of which can cast a negative connotation onto the role.
Before this decade, clinical drug trials for Alzheimer’s disease that had proceeded to Phase 2 recruited patients who had clearly developed symptoms of this type of dementia. The same held true for trials for patients with the other types of dementia: vascular dementia, frontotemporal dementia, dementia with Lewy bodies. By definition then, these participants were ethically vulnerable to proscription into trials. If you can’t remember what the study entails, are you qualified to consent to participation? If you lack the ability to weigh the consequences of your decisions based on other cognitive deficits, are you really able to understand that your participation in the study is voluntary? Could you get yourself out of the study if it proved unsafe or inconvenient or even painful for you?
To help protect participants with cognitive impairment severe enough to qualify as dementia, researchers enlist a trial partner for each vulnerable participant. Not only could the trial partner vouch that the researcher had not coerced the patient into participating, but that partner was likely a more reliable historian about possible side effects or disease progression over the course of the study. Recall that some types of dementia reduce the patient’s ability to perceive his/her own deficits or to remember them long enough to report at scheduled visits to the trial site.
We’re now at an exciting milestone for Alzheimer’s clinical trials. We have begun to test medications that would stop the disease process before significant losses occur. The recruitment of participants to these studies therefore does NOT include those who won’t remember the study drug dose instructions or who can’t sign informed consent themselves. Do these independently functioning, non-demented participants need to have trial partners?
It may depend on the nature of the clinical trial you are considering. If you are fully independent in daily life, maybe a bit forgetful but doing great with a smartphone to keep you on track with reminders and appointment alerts, you could probably handle signing informed consent and participating in a brief (1 year or less) study. The study would end before you could not make notes and keep appointments by yourself. But some of the new trials are designed to go beyond a single year. One we’ll soon launch in North America will last 4.5 years. Given that recruitment is geared toward elderly people at a higher risk for Alzheimer’s disease than their age-peers, chances are good that cognition will change over that period of time. And we will need a person who is objective and qualified by the participant to give us a sense of that change over time.
Some things to keep in mind when you choose a trial partner:
- Being a trial partner means accompanying the participant to some or all visits. If your potential trial partner has a busy schedule or health considerations that make traveling with you difficult, it’s better to pick someone else. The trial partner does not have to live in your home with you.
- It’s not an automatic assumption that your spouse/partner will make the best trial partner. If you tend to disagree with that person’s impression of you or if your relationship is the type that doesn’t tolerate taking instruction, you might want to choose someone else. Trial partners often serve as another pair of ears for the study instructions, and therefore they may act as “deputies” to help make sure the study protocol is followed.
- If you will be counting on the trial partner to help you stay organized (what pill pack this week? When do we go back in for a brain scan? Which location do we go to this time?), pick someone who you think can fulfill that assignment. The study team will do their best to send reminders, but a disorganized trial partner can derail your completion of study-related tasks.
- Who’s your back-up? We have seen some trial partners “fall by the wayside” during a study. Some of this is due to other life matters having to take priority or unexpected health issues or even death. Most of us will be happy to sign you on with notes about who might act as your second trial partner, even if this manifests as a short-term, transient occurrence.
- Not all studies will allow two life partners to be each other’s trial partners. If one develops dementia despite participation in the study, that brings us back to “Who’s your back-up?” above. Research teams may benefit when you reach out to the rest of your social circle – getting others outside of your household involved helps spread the word and speed up recruitment. Speeding up recruitment speeds up the time we’re all waiting to reveal whether the study drug worked the way we wanted it to.