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Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities
Jayabharathi Vaidyanathan1, Elimika Pfuma Fletcher1, Anuradha Ramamoorthy1
1Office of Clinical Pharmacology, Office of Translational Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Abstract:
The prevalence of obesity has grown tremendously in recent years and this population has an increased risk of disease comorbidities. The presence of disease comorbidities requires treatment interventions and proper dosing guidelines. However, drug development programs often do not have adequate representation of individuals who are obese in clinical trials, leaving gaps in the understanding of treatment response leading to a lack of adequate individualization options. Based on a recent survey of approved drug product package inserts, very few approved products included specific dosing based on obesity, in both adults and pediatrics. Reasons for the limited information on patients who are obese may include the under-reporting of information regarding such patients and a lack of clinical trial diversity in enrolling patient groups in whom obesity or obesity-related comorbidities are more prevalent. An inadvertent impact of the practice of exclusion of subsets of patients with some comorbidities in clinical trials may play a role in the reduced enrollment of individuals who are obese. Recently, regulatory authorities have taken specific initiatives to promote clinical trial diversity, including engaging with stakeholders and publishing regulatory guidance. These guidance documents highlight the need to enroll diverse clinical trial populations and provide recommendations on concepts related to drug development for obese populations. Such efforts will help to address the gap in information regarding drug response and dosing in patients who are obese.
Insights
Obesity prevalence is rising, yet clinical trials lack diverse representation, leading to insufficient drug dosing information for obese patients. Regulatory efforts are underway to improve trial diversity and address these critical knowledge gaps.
Area of Science:
- Pharmacology and Clinical Trial Design
- Obesity and Comorbidity Research
Background:
- Rising global obesity rates increase the risk of disease comorbidities, necessitating tailored treatment interventions and precise dosing guidelines.
- Current drug development programs often exclude individuals with obesity, resulting in inadequate understanding of treatment responses and limited personalized medicine options.
- A survey of approved drug labels reveals a significant lack of obesity-specific dosing information for both adult and pediatric populations.
Purpose of the Study:
- To highlight the critical need for improved representation of individuals with obesity in clinical trials.
- To identify reasons for the under-representation and lack of obesity-focused dosing guidelines in drug development.
- To discuss recent regulatory initiatives aimed at enhancing clinical trial diversity for obese populations.
Main Methods:
- Analysis of existing drug product package inserts for obesity-related dosing information.
- Review of clinical trial enrollment practices and their impact on patient diversity.
- Examination of recent regulatory guidance and stakeholder engagement strategies.
Main Results:
- Very few approved drug products provide specific dosing recommendations for obese individuals.
- Under-reporting and lack of clinical trial diversity, including exclusion of patients with comorbidities, contribute to this data gap.
- Regulatory authorities are actively promoting diversity and providing guidance for drug development in obese populations.
Conclusions:
- Addressing the lack of diverse representation in clinical trials is crucial for understanding drug efficacy and safety in obese patients.
- Enhanced clinical trial diversity and adherence to new regulatory guidance will improve drug dosing individualization for individuals with obesity.
- These initiatives are essential to bridge the knowledge gap and ensure appropriate treatment for the growing obese population.
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