Need for Representation of Pediatric Patients with Obesity in Clinical Trials
Abstract
:1. Introduction
2. Importance of Representation of Pediatric Patients with Obesity in Clinical Trials
3. Regulatory Initiatives Related to Clinical Trial Diversity and Obesity
4. Considerations for Strategies to Support Clinical Trial Diversity
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Guidance for Industry * [26] | Overview and Specific Obesity, Race, or Ethnicity-Related Information |
---|---|
General Drug Development | |
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products (Draft, 2022) [17] | Considerations for characterizing dosing and safety of drugs for pediatric use:
|
Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials (Draft, 2022) [27] | Recommendations for inclusion of participants from underrepresented racial and ethinic groups in clinical trials |
Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs (Final, 2020) [28] | Approaches to increase enrollment of underrepresented populations in clinical trials:
|
Developing Products for Weight Management (Draft, 2007) [29] | Recommendations for developing development of drugs and therapeutic biologics for weight management |
Specific Therapeutic Areas | |
Development of Anti-Infective Drug Products for the Pediatric Population (Final, 2021) [30] | General recommendations for developing anti-infective drug products:
|
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy (Draft, 2019) [31] | Recommendations for designing clinical trials for hormonal drug products to prevent pregnancy:
|
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (Draft, 2018) [32] | Recommendations for the development of drugs for noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis:
|
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax (Final, 2018) [33] | Recommendations for development of drugs for prophylaxis of inhalational anthrax:
|
Drug Product Labeling | |
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (Final, 2016) [34] | Recommendations for presenting clinical pharmacology information in prescription drug labeling (i.e., CLINICAL PHARMACOLOGY section):
|
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Samuels, S.; Vaidyanathan, J.; Fletcher, E.P.; Ramamoorthy, A.; Madabushi, R.; Burckart, G.J. Need for Representation of Pediatric Patients with Obesity in Clinical Trials. Children 2023, 10, 1640. https://0-doi-org.brum.beds.ac.uk/10.3390/children10101640
Samuels S, Vaidyanathan J, Fletcher EP, Ramamoorthy A, Madabushi R, Burckart GJ. Need for Representation of Pediatric Patients with Obesity in Clinical Trials. Children. 2023; 10(10):1640. https://0-doi-org.brum.beds.ac.uk/10.3390/children10101640
Chicago/Turabian StyleSamuels, Sherbet, Jayabharathi Vaidyanathan, Elimika Pfuma Fletcher, Anuradha Ramamoorthy, Rajanikanth Madabushi, and Gilbert J. Burckart. 2023. "Need for Representation of Pediatric Patients with Obesity in Clinical Trials" Children 10, no. 10: 1640. https://0-doi-org.brum.beds.ac.uk/10.3390/children10101640