Regulatory Affairs Certification (RAC) Practice Exam

Which study design consideration is LEAST relevant when submitting a clinical study plan under the Pediatric Research Equity Act?

1. A Compare safety in pediatric and adult patients

2. B Evaluate product effectiveness

3. C Assess economic impacts

4. D Ensure compliance with adult regulations

The correct answer is: C Assess economic impacts

The focus of the Pediatric Research Equity Act (PREA) is primarily on ensuring that pediatric populations are considered during the development of new drugs and biological products, particularly regarding the safety and efficacy of these products in children. The act mandates that clinical studies assess both the effectiveness of the product and its safety in pediatric populations compared to adults. When evaluating the options, assessing economic impacts is the least relevant consideration in the context of PREA submissions. The core intent of the act is to generate data that directly pertains to the pediatric patient population's health outcomes rather than economic factors. Hence, while understanding the economic implications of a drug is essential for broader market access and healthcare decisions, it does not fall within the specific study design considerations mandated by PREA. In contrast, comparing safety between pediatric and adult patients and evaluating product effectiveness are integral components to ensure that products are safe and effective for younger populations. Ensuring compliance with adult regulations is also relevant since the regulatory framework requires adherence to established safety and efficacy standards that might have been derived from adult studies. Therefore, option C stands out as the least relevant consideration when formulating a clinical study plan under PREA.