Since the outbreak of Covid-19, there has been a sudden change in the conduct of clinical trials to ensure that patients are safe and have access to their treatment. How does this change affect the number of Paediatric Clinical trials?
When clinical trials are planned without the participation of paediatric population, important aspects are often overlooked and valuable information is lost. Children, adolescents, and youth often do not have the opportunity to contribute to the discussion of the plan, so they do not listen. It is understandable that there are generally fewer clinical studies for the young patient, only for a short duration as compared to adult trials, Hence there will be limited clinical data in paediatric population.
“Smart people learn from everything and everyone, average people from their experiences, stupid people already have all the answers.”.
We believe it is imperative for sponsors to provide as much patient feedback as possible in their research efforts. If encouraged to share their thoughts and experiences during a clinical trial program, paediatric subjects may feel more engaged and involved in participating in clinical trials. By better understanding the current protocol strategy and needs of pediatric research participants, we can help them make tactical decisions, improve current testing practice, and proactively plan for future Clinical Studies.
Overall, children have a milder disease than adults, but they are at greater risk of serious illness and complications of COVID-19. The paediatric approach to acute COVID-19 is similar in adults and includes shortness of breath, cramps, myocarditis, acute renal failure, and coagulopathy. Multisystem inflammatory syndrome (MIS-C) in children is a new syndrome that affects a minority of children during COVD-19 infection and has characteristics similar to other paediatric inflammatory conditions, including Kawasaki disease. Infants usually require intensive care. It is important to maintain a wide variety when assessing sick children during infection; Children with SARS-CoV-2 infection may have a serious condition such as congenital or diabetic ketoacidosis. Although most children and adolescents have a fancy course of the disease, it has been proven that some patients may develop a more serious clinical condition, particularly pre-existing comorbidity and later MIS-C.
The onset of symptoms and hospitalization are lower in the MIS-C group (on average, 2 vs. 5 days). This may be explained by the most severe cases which have some symptoms of trauma and heart failure. The main clinical symptom during hospitalization is usually shortness of breath or gastrointestinal origin. Among children, this is a new phenomenon associated with COVIT-19, and most of these patients require supervision by PICUs and other pediatricians.
Another finding consistent with heart disease of the MIS-C group is inflammation of the chest identified with radiography, which is rarely seen in the non-MIS-C group. Relative to previous reports, chest X-rays and CT scans showed extensive penetration in most patients and other radiological investigations of diffuse bilateral interstitial infiltrate. MIS patients had more severe symptoms, inflammatory biomarkers, and greater male dominance.
- The Screening of Paediatric population is the same as for adults, including test methods and recommended product types.
- The Centers for Disease Control and Prevention (CDCP) provides guidelines for screening infants of mothers who are suspected or confirmed for COVID-19.
Global pathogen COVID-19 has a significant impact on clinical trials in children and adults. Numerous experiments have hampered the progress of clinical studies, and there are challenges in conducting long-distance trials, undertaking laboratory evaluations and other studies, and managing outpatient care. In addition, the final evaluation to the end of these clinical projects is also highly affected.
- For pediatric studies of immunosuppressive therapies, investigators and families might be concerned about the risks of study drugs, 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.
- Among patients with the highest risk of severe COVID-19 infection (e.g., pediatric cancer patients), enrolment may be limited to trials that are expected to show evidence of efficacy in patients.
- It is important to ensure that patients with dementia (including symptoms of COVID-19 and patients who have not recently experienced COVID-19) do not participate in any clinical study.
- 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 the increased duration of treatment may have a positive effect, this is helpful to patients, whereas, in long term studies where the 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.
- BBMCT can provide a wide range of experimental options, which can help maintain the value of data collection and clinical testing. However, due to the risk of COVID-19, even pediatric clinical trials may be delayed due to reduced access to patient care. Exposure to nurses and families for fear of infection spread from skilled health workers may increase at home.
- Informal trials and other clinical trials that are not useful for patients should be considered to assist in the characterization of COVID-19 treatment, particularly in the context of complications and incentives to patients.
COVID-19 infection affects the care of pediatric patients as a whole in many ways, so it affects participation in clinical trials. Although current data suggest that COVID-19 infection may be mild or even symptomless in pediatric patients, those who are younger or have significant medical conditions are at increased risk of developing serious infections. In addition, due to the high incidence of infectious diseases, children may contribute to the spread of COVID-19 in the community.
Depending on the expected duration of social distancing measures, child care providers should consider other voluntary options to maintain quality of care. They may need to transform the pharmaceutical industry into the development of a treatment that will make it easier for patients to self-administer at home.
This is a wonderful time for paediatricians, health researchers, and children themselves. BBMCT has comprehensive information that can add technical solutions to these tests if possible to help reduce stress.