Mom And CCRP Identifies Must-Haves For Pediatric Trials
By Samantha Sharpe, CCRP
Face-to-face interaction is becoming less present as we move toward a technologically integrated society. In the field of clinical trials, there has been a massive push in the last few years to utilize technology to make clinical research operations more efficient. While those digitalization and decentralization efforts might save time and money, they can’t replace the in-person interaction that is often integral to the patient recruitment and enrollment process, which is a known struggle in the field of clinical research. In fact, reports show that around 70% of trials have start-up delays, 80% fail to achieve on-time enrollment, and 45% miss completion targets. By shifting toward a patient-focused, inclusive approach and including principles of shared decision-making, the patient recruitment and consent process can be transformed into an invitation for study participation.
Both recruitment and retention can be improved by making small changes to techniques and implementing cost-effective methods to reduce barriers and make participants feel more included in the overall research process. From study design to patient engagement, I have learned some subtle adjustments and tactics during my career in managing investigator-initiated studies at an academic medical institution that can yield increased engagement and create a lasting impact on the research participant’s experience.
Before we move on, you should know that in addition to my professional career as a clinical research project manager with over a decade of experience designing and implementing pediatric investigator-initiated trials at an academic medical institution, I also have a full-time “career” as a parent. My children — one of whom has a rare disease — have been participants in numerous clinical research studies. I also have personally participated in studies. Sometimes we have enrolled as a healthy control, other times as study subjects. We have participated in both observational and interventional studies, some with a one-time visit and some lasting weeks and months. Combined, these roles yield a perspective from both sides of the clinical research experience. This article is meant to share pediatric patient recruitment and retention tips that have been professionally refined, as well as provide practical advice from the viewpoint of a parent and participant.
Recruiting A Child Means Recruiting The Family
When recruiting pediatric patients, regardless of study design or disease area, all recruitment efforts distill to one main tenet: you are recruiting the entire family unit. Most approach, consent, and recruitment tactics mirror methodologies successful in adult populations, but I would challenge study teams to rethink their recruitment plan. What we are really seeking is parental engagement as well as participation from their child. Local assent guidelines apply, meaning that at a certain age, children also are asked to consent to their participation in research studies before enrollment, but for most pediatric populations, a parent or guardian is going to make the “lift” and decision for research participation by supporting their child mentally, emotionally, and physically throughout the course of the study. That said, for those designing studies, some adjustments can enhance the research experience for families.
Families Need Flexibility
The first actionable, and often most impactful, change is to incorporate flexibility into the design and schedule of events. The protocol and schedule of events are often designed to maximize data points and results. Most people who have been around children can attest to their need for flexibility and how quickly interruptions pop up and derail even the best of plans. Additionally, care should be taken to consider family obligations, such as school calendars, childcare considerations, and caregivers’ work schedules. Even those without children can attest to the delicate balance of competing interests and obligations in our daily lives.
As such, protocol development teams should be challenged to find any wiggle room in the study design that can offer flexibility while also maintaining scientific integrity. That wiggle room can enhance the overall participant experience. Those designing trials should also consider how to maximize the schedule of events and patient contact while minimizing the time a participant (and their family) needs to be engaged with study personnel. In practice, this can look like careful discernment around what study tasks must be conducted in-person versus remotely (such as specimen collection and clinical observation vs. parental data collection) as well as minimizing or combining invasive clinical procedures.
Ideally, before finalizing a study protocol, sponsors would solicit advice from a family advisory council or other community engagement group to help identify any potential roadblocks ahead of study launch. Ultimately, these thoughtful considerations of the time and commitment that a family is giving to the research study and how their experience can be enhanced can lead to better engagement and retention, as well as willingness from study participants to engage with future trials.
These considerations must also flow through to the administrative and implementation teams to provide adequate financial support to clinical research study sites for patient incentives and patient-facing accommodations. These budgetary considerations are necessary for study staff to fully care for participants and their families as they engage in studies. When crafting a study budget, consider what would actually serve as appropriate compensation for the time and attention a participant and their parent or guardian are dedicating to the study. The time of a parent is worth the investment of the sponsor, whether for in-person visits or remote diary and survey completion.
Money May Talk — But So Do Snacks
While on the topic of “time is money,” clinical research teams can make an impact in ways that aren’t direct monetary compensation but rather are provisions meant to enhance the overall participant experience: convenient parking, free transportation, or food vouchers. Traversing a large clinical research site or having to spend time in a parking garage or on shuttles is not enjoyable for anyone, much less for research participants, and alleviating that stress and inconvenience can go a long way in the overall experience and retention for participants.
As before with the need for flexibility, most people who have been around children can attest to their need for snacks (seemingly continually!). Being mindful of the time commitment for the family and offering small snacks in the research clinic or a food voucher for a nearby restaurant or food court as part of study participation can go a long way to ensuring that the participant family has an enjoyable experience and can contribute to overall retention in the study.
Fun And Free Go A Long Way To Participant And Parent Satisfaction
In pediatrics, consider including fun and sometimes “unconventional” research costs as budgetary line items outside the typical scope to improve the overall patient and parent experience. The overall itemized cost is likely quite small, and sometimes even free, but the impact on the participant is large, a worthy and valuable investment. All of us like to feel appreciated and are moved when we feel that someone has gone above and beyond to show their gratitude, and research participants are no different. The suggestions below are key ways to add the “human touch” of thoughtfulness and respect to the clinical research experience.
For the kids:
- Give them things to make the visit fun and special! Stickers, cool and colorful Band-Aids, dollar-store toys, and small treats such as lollipops are great options.
- Provide a visit “souvenir.” Getting to keep the tourniquet used in the venipuncture or receiving a certificate with their name on it to bring to show-and-tell at school is a tactile takeaway that allows kids to take pride in their participation and share the experience with others.
- Staff interactions with the children go a long way, even if all that encompasses is listening to a story about their current favorite character or hearing the long list of dinosaur names they have memorized and can pronounce with ease.
- Snacks!
For the parents/caregivers:
- Free and fast Wi-Fi enables parents to work remotely during longer study visits and assessments.
- Provide easy, free parking or a study location along public transportation routes.
- Compensation in the form of debit cards or generic gift cards (like VISA) is more attractive than those to a specific store.
- Parent education on ways to support their children during research procedures, such as comfort holds for children, is appreciated. Child life specialists are wonderful in this aspect of research.
- Making the study team or investigators available to parents when they have questions, either in person or via text, helps with any anxiety they may feel. The human interaction, as opposed to an automated response, also helps the family feel more engaged and involved with the study.
- Again, snacks!
Technology Can’t Replace Human Touch
In closing, I wanted to share a very personal aspect of why I believe clinical research needs to continue to embed a human touch in participant recruitment. I never wanted myself or my children to be anything more than a healthy control in a clinical research study. Yet, life had different plans for us. My son has been diagnosed with both respiratory and hematological conditions, which led him to be involved in clinical research studies. And, in 2021, I was diagnosed with a rare form of cancer. Being embedded in the field of clinical research, I thought I’d be able to quickly and easily find a study that matched our diagnoses and recommended treatment. However, it was shockingly difficult for me to find information about open studies and opportunities that might exist for us. In those moments of strife and struggle, it felt defeating to scroll the web and continually click my mouse in the hope of finding an answer. The detailed clinical research information I was looking for just wasn’t available via technology. Both for my son and for myself, the interaction with a clinical research coordinator would have made all of the difference in our ability to participate in a trial. We were certainly willing and could have benefitted from a person stepping into our world in a thoughtful way. All this is to say, there is a place for optimization and technological streamlining in clinical reach studies, but a wholesale application of technology into the personal commitment of a family to participate and stay engaged in a research study isn’t one of them.
About The Author:
Samantha Sharpe is a passionate supporter of clinical research project development and utilizes her wide-ranging experience to provide a broad-view approach to academic research management. She is an advocate for community involvement in clinical research programs and projects. In addition to her work managing IITs at Nationwide Children’s Hospital in Columbus, Ohio, she is an educator in the field of investigator-initiated trials and pediatric clinical research recruitment. Her next presentation is at the SOCRA 2024 Annual Conference in Las Vegas this September and is titled “Rolling Out the Red Carpet for Research Recruitment.”