ArticleClinical research and regulatory affairs
Special population considerations and regulatory affairs for clinical research.
Article in Clinical research and regulatory affairs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Systematic review of research focused on pregnant and postpartum women living with HIV: A relational ethics perspective.Bioethics · 2021Pooled it
- Peri-operative Medication Dosing in Adult Obese Elective Surgical Patients: A Systematic Review of Clinical Studies.Clinical drug investigation · 2018Pooled it
- Insights into the Complexities of Pharmacotherapy Parameters in Artificial Intelligence Models for Drug Selection, Precision Personalised Medicine and Optimal Therapeutic Outcomes.Pharmaceutics · 2026Review
- Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA-Authorised Medicines.Clinical pharmacology and therapeutics · 2026Article
- PregMedNet: Multifaceted maternal medication impacts on neonatal complications.Nature communications · 2026Article
- Uptake and Use of Biologic Therapies in Paediatric Immune-Mediated Inflammatory Diseases: An Australian Population-Based Study.Pharmacoepidemiology and drug safety · 2026Article
- Obesity and Natural Products: Mechanisms, Therapeutic Potential, and Future Directions.Food science & nutrition · 2026Review
- Utilizing Minimal Physiologically Based Pharmacokinetic Modeling to Bridge Bevacizumab Pharmacokinetics from Adult to Pediatric Patients.The AAPS journal · 2025Article
- PregMedNet: Multifaceted Maternal Medication Impacts on Neonatal Complications.medRxiv : the preprint server for health sciences · 2025Article
- Managing Atopic Dermatitis with Dupilumab in Special Populations: A Case Series Study.Clinical, cosmetic and investigational dermatology · 2025Article
- Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024Review
- Evaluation of gender differences in the pharmacokinetics of oral zileuton nanocrystalline formulation using a rat model.International journal of pharmaceutics: X · 2024Article
- Clinical trials.European journal of hospital pharmacy : science and practice · 2024Article
- Adult and pediatric physiologically-based biopharmaceutics modeling to explain lamotrigine immediate release absorption process.CPT: pharmacometrics & systems pharmacology · 2024Article
- Self-medication among pregnant women in comparison to the general population: a scoping review of the main characteristics.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2024Article
- Reconsideration of the current models of estimated kidney function-based drug dose adjustment in older adults: The role of biological age.Clinical and translational science · 2023Review
- Sex Differences in Pain and Its Treatment.Handbook of experimental pharmacology · 2023Review
- Recent clinical trials with stem cells to slow or reverse normal aging processes.Frontiers in aging · 2023Review
- Guidance on interim analysis methods in clinical trials.Journal of clinical and translational science · 2023Review
- Drug-Drug Interactions in People Living With HIV at Risk of Hepatic and Renal Impairment: Current Status and Future Perspectives.Journal of clinical pharmacology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of "special population" exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.