Pediatric Clinical Trials _ Challenges and Ethical Considerations

Even with all the modern-day innovations in clinical research, Pediatric Clinical trials still present an ethical and legal dilemma due to the concerns regarding the well-being of the children participants involved. The scientific merit of the clinical study protocols and expected positive outcomes need to be justifiably better than the level of risk exposure to the child. Apart from health risks, the other potential ethical challenges in pediatric clinical trials are related to consent, compensation, and competency.

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Challenges and Ethical Considerations:

• Minimizing Risks:

According to the Convention on the Rights of the Child adopted in 1989 by the UN General Assembly, "Children have the right to the highest attainable level of health."

Minimizing acceptable risks should be one of the critical responsibilities of all the stakeholders involved in pediatric clinical trials. One cannot include Healthy children in studies that involve more than minimal risk (well-defined in research protocols) without any direct benefit to the child. We should take a guarded approach while considering placebo-controlled trials in children. The justification for a placebo decreases when evidence increases towards an effective treatment option.

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• Consent Issues:

Incomplete information to parents/guardians of children involved in clinical trials during the informed consent process is an ethical concern of great seriousness. Also, institutionalized and other similarly vulnerable children often need additional care in the informed consent process to protect against unnecessary trials due to the careless attitude of their gatekeepers.

In addition to the consent from the legally authorized representative, we often need willingness from the participating children (Assent). With increasing age, maturity and experiences of illness, children are in a better position to make an informed decision about participating in the trials.

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• Controversies around Compensation:

The pros and cons of compensation in clinical trials have been debated for a long time now. Pediatric clinical trials make this debate even more complicated. Parents or guardians can sometimes be coerced to participate in the clinical study due to the nature of the compensation offered. There should be enough safeguards in the study design and protocols to protect against such ethical mishaps in pediatric clinical research.

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• Competency Deficit:

Sometimes, due to a deficit of pediatric clinicians, clinician-investigators without adequate pediatric qualifications, expertise, and experience are leading clinical trials involving children. Such a team of investigators must adhere to clear guidelines and protocols to seek external opinion when in-house expertise is not readily available. Also, the ethics committee needs to gauge the research proposal to warrant the appropriateness of the study and its design. There should be surprise visits from the regulators to sites where Pediatric trials are conducted.

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• Age and Developmental Differences:

Children of different ages and developmental stages may respond differently to medications and treatments. Researchers must design studies that account for these differences and may need to conduct separate trials for different age groups or adjust dosages based on age and weight.

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• Long-Term Follow-Up:

Many pediatric conditions require long-term follow-up to assess the efficacy and safety of treatments over time. Researchers must consider how to maintain contact with participants and ensure compliance with follow-up visits and assessments, which can be challenging due to changes in family circumstances and logistical barriers.

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• Regulatory Considerations:

Regulatory agencies have specific requirements for pediatric clinical trials to ensure the safety and welfare of participants. Researchers must adhere to these regulations and obtain approval from ethics committees and regulatory authorities before initiating trials involving children. There should be child behaviour psychologist for each of such sites inhouse or consultant to identify the early signals of any depression or physiological changes affecting the child’s participation in the trial.

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Addressing these challenges and ethical considerations requires collaboration among researchers, clinicians, ethicists, regulatory agencies, and patient advocates to ensure that pediatric clinical trials are conducted ethically and with the utmost regard for the safety and well-being of participants.

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