Pediatric Clinical Trials Model Optimization of the Caregiver Role

I recently wrote a series of articles exploring the clinical trial experience from numerous angles. Among other objectives, I was eager to discover how clinical trials could better utilize the caregiver and, as such, optimize the experience for everyone involved. I was unsure about what I was going to find and ended up being pleasantly surprised.

Everyone I interviewed was passionate about their involvement in the clinical trial process -- eager to share their insights and help educate others. They were excited about the role clinical trials play in developing cures for numerous diseases, and at the same time, they were realistic about the possible risks involved. Throughout it all, everyone I interviewed supported the idea of involving the caregiver in the clinical trial process -- acknowledging that doing so will make trials easier for the patient, medical team, and clinical trial leaders.

It was not, however, until speaking with Robert Goldsby, MD, pediatric oncologist at UCSF, that I understood how pediatric clinical trials most effectively model the optimal use of caregiver involvement. By necessity, pediatric specialists regularly interface with caregivers, because in the case of child patients, the caregivers are the parents or guardians.

"Clinical trials do have risks," Goldsby explains. "Patients must understand the purpose, aim, risk and potential benefits in determining if [a clinical trial] is the right thing to do in this case. This is critically essential to understand." Parents not only need to explain these risks to their children, Goldsby notes, but also must consent to their children's participation. Parents' role in the consent process, Goldsby emphasizes, is therefore pivotal. For this reason alone, pediatric clinical trials cannot proceed without parent involvement.

In the case of adult patients, chances are that caregivers are not the ones authorizing participation in clinical trials. Even so, caregivers are the ones needing to research and clarify the ramifications of participating in clinical trials, to ensure that their loved ones understand the risks and make informed decisions about participation. In addition, consent issue aside, the parenting and caregiving roles are very much the same: Both parents and caregivers need to drive the patients to medical appointments; help the patients follow clinical trial protocols; observe patient responses to clinical trial medications and procedures; serve as liaison to clinical trial leaders; and otherwise nurture and support the patients throughout the clinical trial process. Maintaining a sense of normalcy is also important, says Goldsby, "making sure things that need to be done, still get done."

As I have said before, when we become caregivers, we suddenly are responsible for lives other than our own. Given the similarities between the parenting role in particular and the caregiving role in general, it is my opinion that clinical trial leaders will benefit from studying the model of pediatric clinical trials, in the interest of optimizing support of the caregiver, and ultimately, the patient. In pediatric oncology clinical trials, for example, there is a large support staff -- including nurse practitioners, registered nurses, social workers, child life experts, and school liaisons:

  • Social workers assist with everything from navigating the insurance maze to finding a place to stay while participating in a trial.

  • Child life experts guide children through special programs, like art and music therapy that help cope with the emotions of cancer.
  • School Liaisons help children continue in school and help school administrators understand what it means for a child to have cancer.
  • I wish similar resources were available to me, as I supported my mother through her own clinical trial experience. Most importantly, I wish someone had carefully discussed the risks, benefits and protocol with me, as pediatric clinical trial leaders do with parents. Even if caregivers are not the ones giving consent, we are -- as the clinical trial leaders I spoke with recognized -- the lynchpins of the clinical trial experience. Given this reality, it is my hope that clinical trial administrators begin designing their protocols with the caregiver in mind.