As understanding advances and precedents are established for DCT-focused development programs, all stakeholders in clinical research will benefit from the adoption of DCTs—including children and families.
Decentralized clinical trials (DCTs) have captured the conversation of our industry, as their benefit has become more widely appreciated during the COVID-19 pandemic. DCTs offer opportunities to radically improve clinical research, both in the immediate and long-term. As understanding advances and precedents are established for DCT-focused development programs, all stakeholders in clinical research will benefit from the adoption of DCTs, even our littlest patients.
DCTs use telehealth and other technologies, mobile and local healthcare providers, or other procedures that vary from traditional clinical trials in order to design a study within the ecosystem of a patient. In a pediatric trial, participation often involves the whole family. Leveraging decentralized elements in a trial can reduce the hurdles that have previously prevented or made pediatric participation in clinical trials difficult.
As in adult studies, DCTs make participation easier in pediatric trials by reducing the number of onsite visits to participate. Utilizing home health care allows for measurements and appointments to be taken in the home, which reduces travel time to the site—a common burden on patients and hinderance to participation.
“If a child is three hours away from a site, the day of a visit, they and their parents would need to miss school and work to make the appointment,” says Dr. Isaac Rodriguez-Chavez, PhD, Senior Vice President and head of the Strategy of the Center of Excellence for Decentralized Clinical Trials at PRA. “Many families cannot afford to take off work or lose wages for the appointments needed to give their child the care they need.”
Many parents are also single parents, without the flexibility of an additional partner to assist with the trial commitments or childcare for other children. Home health care, shipping drugs to the patient’s home, and leveraging telehealth measures all reduce or eliminate the need to attend a visit on site.
Decentralized elements make treatment through clinical research as a care option (CRAACO) much more accessible and enable diversity of patients included in DCTs. Besides home health care, mobile apps and technologies can even bring the trial onto the devices they already own.
“DCTs reduce the geographical and financial barriers to engage in DCTs, making participation possible to wider demographics and gaining the clinical data needed to ensure a medicine is safe and effective across demographics,” says Isaac.
Pediatric illnesses often have small population pools, meaning patients are dispersed more widely geographically, increasing the likelihood they are far from a participating clinical research site. Access to viable transportation means can also be a challenge depending on location. These small patient pools and their associated challenges make recruitment and access to patients a common challenge for research organizations, and any measures to improve access helps. DCTs are a more accessible and attractive option for families because it fits more naturally into their existing lives.
Other considerations for children in pediatric clinical trials are the psychological impacts of illness at a young age. For children, missing school and the ability to socialize or feel “normal” in their social circles can be a confusing and potentially devastating experience. DCTs allow or children to remain in their environments (e.g., their schools) more consistently and to maintain the highest degree of normality that their illness affords them. When possible, having blood draws or other measurements performed at home or locally at a clinical diagnostic laboratory also reduces the stress children often feel in a clinical setting. These processes keep them in their routine environment.
Siblings and their care and needs are also an important consideration for pediatric clinical trials. Families with sick children may have to prioritize the care of the sick child at the well-intentioned expense of the other children. Even if a parent can take time off work to pull a child out of school to participate, they may have other children who would have to miss school, too. Besides school, children have other activities such as play dates, clubs, and sports practices that provide quality of life and should be protected when possible. Pediatric illnesses often have psychological impacts on parents and siblings as well who both feel the stress of the situation and unintended consequences of ensuring the best care for the sick child. DCTs allow siblings to retain more of their normal life and receive more attention from parents, improving the experience for the whole family.
DCTs also engage the parents and patients more fully and allow for touchpoints along the clinical trial journey as needed. They create improved sense of community between patients/parents and their care team and can even implement 24/7 patient/parent support methods that allow concerns or questions to be addressed immediately, no matter the day or time or availability of their investigator.
When participation is less of a burden and interruption to daily life, compliance is higher because it’s easier to comply with the schedule and other study commitments. Of course, when compliance is higher, the data quality is stronger, the retention rates are improved, and the trial overall produces better results.
To ensure that families are best positioned to understand the benefits of DCTs, it’s important that our industry work closely with sites. Isaac emphasized, “Investigators are an important part of patient recruitment and retention and their full understanding of DCTs will be an important piece to ensuring DCTs gain a strong foothold in the future of clinical trials.”
Considering pediatric clinical trials, parents are concerned about the safety and well-being of their child. Clinical trials are almost always a new and unknown treatment option and building trust and comfortability with the parents will require an investigator’s deep understanding of the DCT.
“We need investigators to champion the benefits of a DCT to parents and their children and who are mindful of the ways to ensure the parents still feel comfortable and supported despite the decreased face-to-face interaction,” says Isaac.
Pediatric centers are committed to finding innovative ways to relieve burden on patients and their families, and once they understand the benefit to their families and to them, they are invaluable to increasing adoption rates of DCTs.
Not all trials can be fulfilled using a decentralized model—you must figure out what is practical for the sites, patients and families, and those running the trial. “The same line of thinking is applicable to traditional clinical trials, which are not universally best suited for all therapeutic indications in populations of all ages,” says Isaac. “There are multiple considerations that need to be carefully analyzed when selecting a specific trial design and implementation approach. DCTs are agnostic to trial designs and therapeutic areas which is an important advantage, and they are irreversibly becoming mainstream in the clinical research enterprise globally.”
DCTs have the ability to greatly improve the treatment experience for the entire care circle for a sick child. As our industry continues to advance the adoption of DCTs for adult trials, it is important to consider the improvements to participation that DCTs afford pediatric trials.
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