Rose Eleanor Keller,1 Sneha Dave,1 Katherine Melton1,21Generation Patient, Indianapolis, IN, USA; 2Department of Nursing Professional Practice, Rhode Island Hospital, Providence, RI, USACorrespondence: Katherine Melton, Department of Nursing Professional Practice, Rhode Island Hospital, 593 Eddy Street, Providence, RI, 02903, USA, Email kmelton@brownhealth.orgAbstract: Clinical trial design and results often do not adequately address the needs of young adult patients (ages 18– 35 years), despite the increasing prevalence of chronic conditions among young adults in the United States. A group of medical professionals, pharmaceutical industry representatives, and young adults with chronic conditions convened in a roundtable discussion hosted by Generation Patient to identify current barriers to young adult clinical trial participation and propose strategies to improve the research process for young adults. The discussion explored the added complexities of young adulthood, including developmental and situational instability and the transition from pediatric to adult care, which can make clinical trial participation more difficult and less appealing; the benefits of increased, proactive collaboration between young adult patients and researchers at every stage of the research process; and practical changes to ensure that data reporting reflects potential outcomes or dispositions unique the young adult patient population, such as arriving at a national consensus around the operational definition of "young adult” and disaggregating safety and efficacy data within finer age brackets. All stakeholders highlighted the need to make medical research more inclusive of young adults so they can be well-equipped to make informed medical decisions.Keywords: patient perspective, roundtable, chronic illness, advocacy
Purpose: To evaluate the efficacy and safety of EnXtra (R) (Alpinia galanga extract) alone, caffeine and its combination with caffeine on mental alertness and fatigue in healthy sleep-restricted adults through acute single-dose and sub-acute 28-day supplementation protocols. Patients and Methods: This randomized, double-blind, placebo-controlled study consisted of two stages: an acute crossover design (n=128) and a sub-acute 28-day parallel design (n=127). In both the stages, participants aged 18-40 years with habitual caffeine intake received one of the following interventions: A. galanga extract (300 mg), caffeine (200 mg), A. galanga extract (300 mg) + caffeine (200 mg), or placebo (300 mg). The primary outcome was mental alertness evaluated using the Jin Fan Attention Network Test (ANT). Secondary outcomes included fatigue (Samn-Perelli Fatigue Scale (SPS)), psychomotor performance (Nine-Hole Peg Test), sustained attention (Continuous Performance Test), and safety parameters. Cognitive assessments were performed at 0, 1, 3, and 5 hours post-dose in controlled environments on each scheduled visit (Days 0, 5, 10, 15, 20, and 48). Results: In both acute and sub-acute phases, A. galanga extract showed statistically significant improvements in alertness compared with placebo at selected time points. The combination group demonstrated greater improvements in alertness compared with placebo in several assessments. Improvements in fatigue scores were also observed with A. galanga extract alone and in combination with caffeine, with statistically significant reductions compared with placebo at certain time points. Trends toward improvements in psychomotor performance (NHPT) and sustained attention (CPT) were observed with A. galanga extract, although these changes were not consistently statistically significant. In the sub-acute phase, caffeine showed improvements in alertness and fatigue primarily at 1 hour post-dose, with limited effects at later time points. Conclusion: Alpinia galanga extract, alone or combined with caffeine, significantly improved mental alertness and reduced fatigue without caffeine-associated rebound effects, with both interventions showing good safety profiles in healthy adults.
Andre Williams,1 Cassandre Horne,1 Katherine Freeman2 1Christine E. Lynn College of Nursing, Florida Atlantic University, Boca Raton, FL, USA; 2Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USACorrespondence: Andre Williams, Email andrewilliams@health.fau.eduAbstract: Clinical trials constitute a cornerstone of contemporary medicine and healthcare, as they generate the highest level of empirical evidence regarding the safety and efficacy of pharmacological agents and other therapeutic or preventive interventions. Although strategies to address underrepresentation exist, a critical gap in the literature is the lack of comprehensive, operationalized approaches that integrate study design, social determinants of health (SDOH) data, statistical methodologies, reporting practices, and applications of artificial intelligence and machine learning (AI/ML). To address this gap, the Perspective outlines populations that are typically underrepresented, discusses the ramifications of this underrepresentation, and presents a comprehensive set of strategies to enhance representation and promote generalizability in clinical trials. The five components detailed in the following sections are: (1) defining inclusion and exclusion criteria that balance internal and external validity and reflect the broader affected community; (2) collecting and operationalizing SDOH and demographic data to understand factors associated with treatment outcomes; (3) using statistical adjustment techniques to account for diverse representation in results; (4) ensuring comprehensive clinical trial reporting to support transparency and reproducibility; and (5) leveraging AI/ML to optimize study planning and data analysis.Plain Language Summary: Making Medical Research Work For Everyone: Clinical trials test whether new medicines and treatments are safe and effective. However, many trials do not include enough participants from key groups, such as older adults, racial and ethnic minorities, people with lower incomes, rural residents, and women. When these groups are underrepresented, we cannot be sure if the treatment will work the same way for everyone in real-world settings.This Perspective explains why this underrepresentation happens and why it matters. More importantly, it provides a practical guide to fix the problem. The authors propose five strategies: (1) using real-world health data to design fairer eligibility rules; (2) collecting and analyzing information about social and demographic factors that affect health; (3) using statistical methods to adjust for trial population imbalances; (4) following updated guidelines for transparent reporting of the clinical trial plan and results; and (5) using artificial intelligence carefully to reduce bias, not amplify it.These strategies aim to ensure that future clinical trials include the people who need the treatments most. The goal is better, fairer healthcare for all.Keywords: clinical trial methodology, external validity, underrepresented populations, generalizability, artificial intelligence in clinical research
Kiran Dattatray Pandit,1,* Rajesh Eknath Patil,2,* Abhijeet Ashok Morde,3,* Paras Pravin Patni,3,* Sanjay Vishnu Vaze,4,* Poonam Shrikant Gotal5,* 1Department of General Medicine, Gurukrupa Hospital, Thane, Maharashtra, India; 2Department of General Medicine, New Manak Healthcare Hospital, Navi Mumbai, Maharashtra, India; 3Research & Development, OmniActive Health Technologies, Mumbai, Maharashtra, India; 4Department of Clinical Development, Vedic Lifesciences Pvt. Ltd., Mumbai, Maharashtra, India; 5Department of Science and Communication, Vedic Lifesciences Pvt. Ltd., Mumbai, Maharashtra, India*These authors contributed equally to this workCorrespondence: Abhijeet Ashok Morde, Research & Development, OmniActive Health Technologies, Technology Center, First Floor, A-10, Road 1, Wagle Estate, Thane West, Mumbai, Maharashtra, 400604, India, Tel +91 9594096454, Email a.morde@omniactives.comPurpose: To evaluate the efficacy and safety of EnXtra® (Alpinia galanga extract) alone, caffeine and its combination with caffeine on mental alertness and fatigue in healthy sleep-restricted adults through acute single-dose and sub-acute 28-day supplementation protocols.Patients and Methods: This randomized, double-blind, placebo-controlled study consisted of two stages: an acute crossover design (n=128) and a sub-acute 28-day parallel design (n=127). In both the stages, participants aged 18– 40 years with habitual caffeine intake received one of the following interventions: A. galanga extract (300 mg), caffeine (200 mg), A. galanga extract (300 mg) + caffeine (200 mg), or placebo (300 mg). The primary outcome was mental alertness evaluated using the Jin Fan Attention Network Test (ANT). Secondary outcomes included fatigue (Samn-Perelli Fatigue Scale (SPS)), psychomotor performance (Nine-Hole Peg Test), sustained attention (Continuous Performance Test), and safety parameters. Cognitive assessments were performed at 0, 1, 3, and 5 hours post-dose in controlled environments on each scheduled visit (Days 0, 5, 10, 15, 20, and 48).Results: In both acute and sub-acute phases, A. galanga extract showed statistically significant improvements in alertness compared with placebo at selected time points. The combination group demonstrated greater improvements in alertness compared with placebo in several assessments. Improvements in fatigue scores were also observed with A. galanga extract alone and in combination with caffeine, with statistically significant reductions compared with placebo at certain time points. Trends toward improvements in psychomotor performance (NHPT) and sustained attention (CPT) were observed with A. galanga extract, although these changes were not consistently statistically significant. In the sub-acute phase, caffeine showed improvements in alertness and fatigue primarily at 1 hour post-dose, with limited effects at later time points.Conclusion: Alpinia galanga extract, alone or combined with caffeine, significantly improved mental alertness and reduced fatigue without caffeine-associated rebound effects, with both interventions showing good safety profiles in healthy adults.Keywords: Alpinia galanga, EnXtra®, caffeine, mental alertness, caffeine crash, cognitive enhancement, fatigue
Africa bears a disproportionate share of the global disease burden yet remains underrepresented in global clinical research. Fragmented regulatory systems, variable approval timelines, and limited cross-border coordination have historically constrained multinational trials across the continent. Over the past decade, however, regional medicines regulatory harmonization initiatives and the establishment of the African Medicines Agency (AMA) have begun to transform Africa's regulatory environment. This Commentary reviews progress achieved through regional collaboration, assesses the early role of the AMA, and examines persistent structural and capacity-related barriers. We argue that regulatory harmonization represents a pivotal opportunity to reposition Africa as a central hub for global clinical research. Realizing this potential will require sustained political commitment, investment in regulatory capacity and digital infrastructure, and deeper engagement by global sponsors and funders. Nevertheless, substantial implementation gaps remain, particularly regarding uneven state adoption, sustainable financing, and post-market surveillance capacity. Strengthening Africa's regulatory ecosystem is not only a matter of efficiency, but also an ethical and scientific imperative for producing globally relevant and equitable clinical evidence.
