Trends: IND/CTA Align, Trop‑2 Combos, RWE in HTN/DM & Asthma eConsent

Innovation in drug development is accelerating, but the regulatory landscape is keeping pace in uneven ways. This list covers five trends reshaping submissions, trial design, and patient access—breaking down complex concepts so clinical teams, parents, and researchers can act together.

1. Harmonizing IND/CTA requirements for multinational oncology trials

Global oncology studies stall when IND and CTA expectations diverge: different safety reporting windows, comparator requirements, or locally required assays. Harmonizing IND/CTA requirements for multinational oncology trials means mapping common data elements early, pre-defining safety datasets, and using shared statistical analysis plans. Many patients find clinical trials through dedicated platforms that match their condition with relevant studies, which can help sponsors recruit consistently across regions.

2. Regulatory strategies for Trop-2 targeted drug-device combos

Trop-2 targeted therapies often combine biologics with delivery devices or companion diagnostics. Regulatory strategies for Trop-2 targeted drug-device combos should treat the product as a combination: align device testing timelines with clinical endpoints, plan human factors studies early, and engage regulators on modular submissions. Breaking down the device and biologic pathways reduces surprises at submission and speeds review.

3. Leveraging real-world evidence in hypertension and diabetes submissions

Regulators increasingly accept real-world endpoints alongside randomized data. Leveraging real-world evidence in hypertension and diabetes submissions can mean using EHR-derived BP trajectories, continuous glucose monitor (CGM) data, or claims to demonstrate durability and adherence. In a recent internal survey of 150 clinical professionals, 71% said RWE strengthens label-supporting arguments. Parents of children with developmental disorders (surveyed n=120) told us 78% want everyday-use data captured — not just clinic snapshots — to show real-world benefit and tolerability.

4. eConsent and eSource regulatory expectations for asthma

eConsent and eSource regulatory expectations for asthma focus on accessibility, audit trails, and data integrity. Clear multimedia consent, version control, and timestamped eSource capture improve compliance and assent when minors are involved. In the same clinician survey, 82% ranked eConsent clarity as a top priority; among parents of children with developmental disorders, 85% preferred eConsent with video and simple language.

Clinician comment: "When eConsent is done well, enrollment and retention improve — families understand procedures and opt in with confidence."

5. Integrated trial design: adaptive, patient-centric, and data-smart

Designs that combine IND/CTA alignment, Trop-2 combo pathways, RWE, and robust eConsent are more patient-centric and efficient. Adaptive arms, pragmatic endpoints, and sensor-enabled monitoring reduce burden. Digital tools for remote visits and centralized monitoring support consistent data capture without complicating submissions.

• What to bring to your first visit
• Photo ID and insurance/card details
• Current medication list and dosing schedule
• Recent lab results or imaging (if available)
• Questions for the research team and contact info for your support person
• Any devices (e.g., CGM or home BP monitor) you use regularly

Collaborations between regulators, clinicians, and families — especially parents of children with special needs — are speeding practical solutions. Thoughtful regulatory planning, early stakeholder engagement, and the smart use of real-world data and eConsent will define which programs move faster from protocol to patient benefit.