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FDA Pediatric Ethics Working Group Consensus Statement on the
Pediatric Advisory Subcommittee’s April 24, 2001 Meeting
On April 24, 2001, the Pediatric Advisory Subcommittee met and was supplemented by a number of ethicists, clinicians who care for patients with special needs, and representatives from the cerebral palsy (CP) advocacy community. The subcommittee was charged with providing guidance on the development of antimuscarinic products to control drooling in children with neurologic impairment, especially the development of an optimal dosing strategy that balances benefit and risk.
The FDA Pediatric Ethics Working Group has summarized the discussion of the Pediatric Advisory Subcommittee meeting on development of these products. The consensus areas of discussion were as follows:
With regard to study design and implementation:
- Formulations appropriate for pediatric use should be developed to ensure safety and consistency in administration. These formulations should be palatable and permit easy dose titration. In some cases it would be desirable to have more than one formulation available (e.g., suspensions, chewable tablets, sustained release, transdermal).
- In most cases, the child will be unable to identify expected and unexpected adverse events associated with antimuscarinics. Caregivers will need to take responsibility for this and these assessments should be done in conjunction with regular evaluation by medical professionals.
- A major component of clinical trials should involve caregiver training for assessment of adverse events. Tools for the assessment of safety and efficacy that will permit the development of an optimal dosing strategy should be developed in clinical trials. If these tools are successful, then they should become part of the instructions for use (i.e., direct patient instructions, parent package information, "Dosage and Administration" section of labeling).
- The trial should reflect the clinical care setting, which is usually a team based, multidisciplinary approach (e.g., subspecialties such as Physical Medicine and Rehabilitation, Otolaryngology and Gastroenterology; Dentistry; and Nursing).
Comments regarding the ethical conduct of clinical trials in vulnerable populations:
- Children with disabilities in the care of their parents or legal guardians and who are incapable of effective communication, should not be excluded from clinical trials based solely on their disability.
- As described in 45 CFR 46.406, patients from vulnerable populations with the condition of interest should have access to clinical trials directed at their disease or condition.
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Date created: November 28, 2003 |
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