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                                    [title] => INC Research’s Real World & Late Phase Clinical Trials ISPOR Presentation Highlights:  Postmarketing Commitment Trends in Pediatric Patient Populations
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As a requirement for the approval or continued marketing of medicines, the US Food and Drug Administration (FDA) may require additional information on a product to be generated, in the form of post marketing commitments and requirements (PMC/Rs). These commitments are agreed to by a company with the health authority and are used to gather additional information about a medicine's safety, efficacy, or optimal use.

The Pediatric Research Equity Act (PREA) was passed in 2003 in order to improve the quality of pediatric information in drug labeling. This legislation authorizes FDA to require pediatric studies of marketed drugs that are not adequately labeled for children after other opportunities to obtain data on a voluntary basis have been exhausted. The requirement for such studies may be waived if: studies in children are impossible; there is evidence suggesting the drug will not be safe in children; the drug does not represent a therapeutic benefit over existing therapies for children; or the drug is not likely to be used in a substantial number of children.

INC Research Epidemiologist Jayashri Desai and colleagues Jessica Albano and Susan Sinclair evaluated the trends in FDA PMC/Rs in pediatric populations between 2011 and 2016. During this time, the FDA approved 414 new products of which 74% included at least one PMC/R and 37% were labeled for pediatric use. The number of new product approvals increased annually, as did the proportion of products with a pediatric indication, from 24% in 2011 to 56% in 2015 (Figure 1).

Over the 5-year period, there were a total of 1,153 PMC/Rs, including 555 studies to be conducted in pediatric patient populations of which:

• 89% were for drug products

• 11% were for biologic products

• 92% were safety studies

• 89% were observational studies

The greatest number of pediatric PMC/Rs were seen in infectious disease (25%) and general medicine (12%) followed by CNS (10%), cardiovascular (10%), endocrinology (10%) and oncology (6%) (Figure 2).

During the period under study, the total number of PMC/Rs requested annually increased, as did the number of pediatric PMC/Rs. Despite these increases, the overall proportion of PMC/Rs among pediatric patient populations decreased from 62% in 2011 to 45% in 2015, with some leveling off in the most recent years (Figure 3). While this trend was consistent for both biologic and drug products, additional longitudinal follow-up is needed to discern whether this trend continues, stabilizes or reverses over the long term.

Our Real World & Late Phase (RWLP) clinical trial experts are with you from concept to commercialization to maximize value by providing consultative and operational expertise in real world data generation. Building on our 25 years of experience delivering studies globally, we have the people, processes and technology to design, plan, execute and deliver real world evidence for you, patients, physicians, payers and regulators. Learn more about us at our website.

[summary] => [format] => wysiwyg_limited [safe_value] => As a requirement for the approval or continued marketing of medicines, the US Food and Drug Administration (FDA) may require additional information on a product to be generated, in the form of post marketing commitments and requirements (PMC/Rs). These commitments are agreed to by a company with the health authority and are used to gather additional information about a medicine's safety, efficacy, or optimal use.The Pediatric Research Equity Act (PREA) was passed in 2003 in order to improve the quality of pediatric information in drug labeling. This legislation authorizes FDA to require pediatric studies of marketed drugs that are not adequately labeled for children after other opportunities to obtain data on a voluntary basis have been exhausted. The requirement for such studies may be waived if: studies in children are impossible; there is evidence suggesting the drug will not be safe in children; the drug does not represent a therapeutic benefit over existing therapies for children; or the drug is not likely to be used in a substantial number of children.INC Research Epidemiologist Jayashri Desai and colleagues Jessica Albano and Susan Sinclair evaluated the trends in FDA PMC/Rs in pediatric populations between 2011 and 2016. During this time, the FDA approved 414 new products of which 74% included at least one PMC/R and 37% were labeled for pediatric use. The number of new product approvals increased annually, as did the proportion of products with a pediatric indication, from 24% in 2011 to 56% in 2015 (Figure 1).Over the 5-year period, there were a total of 1,153 PMC/Rs, including 555 studies to be conducted in pediatric patient populations of which:• 89% were for drug products• 11% were for biologic products• 92% were safety studies• 89% were observational studiesThe greatest number of pediatric PMC/Rs were seen in infectious disease (25%) and general medicine (12%) followed by CNS (10%), cardiovascular (10%), endocrinology (10%) and oncology (6%) (Figure 2).During the period under study, the total number of PMC/Rs requested annually increased, as did the number of pediatric PMC/Rs. Despite these increases, the overall proportion of PMC/Rs among pediatric patient populations decreased from 62% in 2011 to 45% in 2015, with some leveling off in the most recent years (Figure 3). While this trend was consistent for both biologic and drug products, additional longitudinal follow-up is needed to discern whether this trend continues, stabilizes or reverses over the long term.Our Real World & Late Phase (RWLP) clinical trial experts are with you from concept to commercialization to maximize value by providing consultative and operational expertise in real world data generation. Building on our 25 years of experience delivering studies globally, we have the people, processes and technology to design, plan, execute and deliver real world evidence for you, patients, physicians, payers and regulators. Learn more about us at our website. 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