At just 12 years old, Maya had already cycled through multiple therapists and two medications. She was intelligent, imaginative, and highly curious, but often labeled as distracted and disruptive. Her teachers marked her as a problem student. Her doctors saw a checklist of symptoms. But no one saw the full picture.

Maya’s story reflects a deeper truth about Attention-Deficit/Hyperactivity Disorder (ADHD): despite the available research and treatments, it remains misunderstood and inconsistently managed. And according to leading researchers at iNGENū CRO, the issue begins not with the condition itself, but with the way it’s studied.

Reframing ADHD: From Behavior to Biology

ADHD was historically regarded as a childhood behavioral issue, often diagnosed in hyperactive boys. Today, science recognizes it as a complex neurodevelopmental disorder affecting individuals across all ages and genders. Presentations vary. Some struggle primarily with inattention, others with impulsivity, and many with both. Yet despite this knowledge, many diagnostic tools and research protocols remain outdated.

Global prevalence estimates place ADHD in 5–7% of children and around 5% of adults. In countries like the United States, diagnoses are widespread and pharmaceutical interventions are common. In contrast, countries like France emphasize environmental causes and behavioral solutions. These cultural and clinical disparities point to a critical challenge in modern research: how can studies produce globally relevant data while addressing diverse patient experiences?

Regulatory Success Doesn’t Always Equal Real-World Success

Five FDA-approved medications — methylphenidate, amphetamines, atomoxetine, lisdexamfetamine, and guanfacine — have long shaped the therapeutic landscape. Clinical trials show they are effective in reducing core ADHD symptoms. However, side effects such as insomnia, appetite suppression, and emotional lability often limit their use in real-world settings.

“Trials that only focus on symptom scores are missing the forest for the trees,” explains Dr. Sud Agarwal, CEO of iNGENū CRO. “We need to ask not just whether a drug reduces fidgeting or improves attention, but how it impacts a patient’s ability to function in school, at work, or in relationships.”

iNGENū CRO’s Shift Toward Patient-Centric Protocols

Headquartered in Australia with FDA-facing capabilities, iNGENū CRO has emerged as a leader in trial modernization. Under Dr. Agarwal’s leadership, the organization champions protocols that mirror the complexity of ADHD itself, blending scientific precision with patient reality.

iNGENū-designed trials incorporate:

  • Subgroup analyses by age, gender, and ADHD subtype.
  • Expanded endpoints, including executive function (measured by BRIEF), academic progress, social development, and quality of life.
  • Digital adherence tools to reduce trial dropout rates.
  • Stakeholder input from educators, caregivers, and patients to ensure studies remain grounded in daily life.

By moving beyond traditional symptom checklists, iNGENū is reshaping what success looks like in clinical trials.

Addressing Research Blind Spots

The team also tackles common pitfalls in ADHD studies: high placebo response rates, underrepresentation of adults and females, and the masking effect of comorbidities like anxiety or learning disorders.

Trial design innovations at iNGENū include wearable data tracking, adaptive dosing protocols, and school-based assessments to gather real-time feedback from the environments where ADHD symptoms most often manifest.

Longitudinal study frameworks further ensure that both short-term relief and long-term functional outcomes are considered, closing the gap between FDA approval and sustained real-world benefit.

A Future of Smarter, More Inclusive Research

The implications of this work are significant. Patients like Maya shouldn’t have to navigate a system that mislabels or overlooks them. They deserve care informed by research that sees them as more than a symptom profile.

That’s why iNGENū is calling on the clinical research community to embrace more inclusive, adaptive trial models that reflect today’s understanding of ADHD.

“There’s no reason ADHD research should remain locked in frameworks designed decades ago,” says Dr. Agarwal. “We now have the tools — and the ethical responsibility — to build studies that are smarter, more diverse, and far more relevant to patients’ lives.”