We often refer to participants as the heroes of research. Trials, and the medical advances made through research, don’t happen without them. But here come the holidays – will your study participant compliance waver during these busy times?
Patient recruitment, retention, and compliance with study visits and procedures are central to the success of clinical trials. Schedules of events don’t provide much leeway, and holiday disruptions can become compliance headaches. Here are tips to get ahead of specific issues to keep your study, and your participants, on track.
Tip 1: Eat, Drink, and Be Compliant
During the holidays, festive food provides tempting opportunities to overeat or indulge in foods that aren’t part of our normal diets. Also, holiday festivities, travel, and gatherings can throw study participants off of their normal schedule. This can potentially disrupt study participant compliance with items such as:
- Dietary restrictions or low-calorie diets
- Exercise schedules
- Alcohol intake limitations
- Caffeine intake limitations
- When to take the study drug
- How to take the study drug (i.e., on an empty stomach)
Provide reminders to participants of study parameters so they can still stay on track with study compliance. Also, you might be able to reschedule a site visit within the visit window if you see that, for example, the site visit occurs the morning after the participant’s gala family soiree.
Tip 2: Help Clear Holiday Disruptions
Holidays can easily unravel a family routine. Your participant may have family members visiting. Or, just having the children home from school all day for a couple of weeks could limit your participant’s availability.
Here are 2 options:
- Can your site arrange child care on-site visit days?
- Can your site provide flexible scheduling with evening or weekend visits?
Sometimes participant compliance rests on overcoming a temporary obstacle.
Tip 3: Work With the Sponsor or CRO to Accommodate Snowbirds
Snowbirds are northerners who move to a warmer southern locale in the winter. If you live in an area where participants are likely to migrate based on the weather (hot or cold), it’s important to assess this prior to enrollment. However, sometimes participants forget to disclose this or their plans change.
If a potential participant is perfect for a difficult to recruit to study and is a snowbird, or you’re trying to keep an enrolled patient in a study, there may be some options to help.
Does the study offer remote options that would work for the times the participant would be out of town? If in-person procedures are needed for these visits, consider working with the sponsor/CRO to see if there is another study site in the destination area and if they would allow (and the site would be willing) to perform the interim study visits.
If your participants see the lengths you are going through to ensure compliance over the holidays, it will likely reinforce to them the importance of not skipping visits.
Participant compliance and retention are challenges even in the best of times, and communication can go a long way. Making sure your participant feels appreciated is a key to compliance and retention throughout the study. A surprising number of participants say they’ve never been thanked for taking part in studies and the holidays are a great time to do this.