By Shipra Patel, M.D., M.S., Senior Medical Director & Heidi Cho, M.D., Medical Director & Jen Salstrom, M.D., Ph.D., Medical Director & Claire Van Eenwyk, M.D., Senior Medical Director
The COVID-19 global pandemic has had a significant impact on the conduct of pediatric and adult clinical drug trials. Many trials have halted enrollment, and there are multiple challenges with setting up remote visits, performing laboratory and other study assessments, and shipping study drug to patient homes. Furthermore, endpoint assessments for these trials have been substantially impacted. The following are several considerations for pediatric clinical drug trials:
- For clinical trials in patients who are more susceptible to severe COVID-19 infections (e.g., pediatric oncology patients), enrollment will likely be restricted to those trials that are expected to show evidence of benefit to patients.
- For pediatric studies of immunosuppressive therapies, investigators and families might be concerned about the risks of study drug, especially in the absence of a vaccine or approved antiviral therapies. It will be important to ensure that patients with an active infection, including COVID-19 symptoms and those with recent COVID-19 exposure, are excluded from participation in these studies.
- For some ongoing pediatric studies, patients might be kept in the study and remain on the study drug for a longer duration than expected, since they will be unable to come to the site for the final study visit. In studies where increased duration of treatment may have a positive effect, this is helpful to patients, whereas in studies where increased duration of treatment creates additional side effects or patients remain on placebo for a prolonged period, this may be detrimental. Safety must be carefully followed and evaluated in any patients on prolonged treatment.
- Parexel can offer options for decentralized clinical trials, which could help maintain data collection and clinical trial quality. Even virtual hybrid pediatric clinical trials, however, might have some setbacks due to the reduced availability of home nursing, considering the risk of COVID-19. exposure for the nursing staff and family fears of having healthcare professionals in their home.
- For noninterventional and other clinical trials for which there is not a clear benefit to the patient, the ethics of participation and potential COVID-19 exposure need to be considered, particularly when patient participation is financially incentivized.
The COVID-19 pandemic affects pediatric patients’ overall care in several ways, while impacting their participation in clinical trials. Although current data suggest that COVID-19 infection tends to be mild or even asymptomatic in pediatric patients, those who are younger or have significant underlying medical conditions are at higher risk for more severe illness. In addition, due to high rates of asymptomatic infections, children might be contributing to community transmission of COVID-19.
Depending on the anticipated duration of social distancing measures, additional innovative and virtual options will need to be considered by pediatric healthcare providers to maintain the overall quality of care. There may also need to be a shift in the clinical trial industry towards developing therapies which are easily self-administered by patients at home, as well as virtual tools to screen for chronic pediatric diseases.
This is an extraordinarily challenging time for pediatric healthcare providers, clinical researchers and the children themselves. Parexel has a full range of virtual solutions that can be incorporated into these trials whenever possible to help minimize the disruption.
For a more complete exploration of the implications of COVID-19 on Pediatric Clinical Trials, please read our article COVID-19 Risks for Pediatric Patients and Implications for Clinical Trials.