Guide to Integrating Decentralized Trials with Global Regulators

Decentralized trials are changing how sponsors work with regulators around the world. This practical guide walks you through five action-oriented steps to align hybrid and remote trial designs with global expectations — from oncology accelerated approvals to multinational safety workflows.

1. Build a regulatory-first decentralized strategy

Start by mapping requirements across your target regions and by therapy area. Integrating decentralized trials with global regulatory expectations means reviewing ICH guidelines, regional eConsent rules, and local data residency laws early. Operationalizing accelerated oncology approval pathways requires close alignment with agencies on endpoints and remote assessment validity, so flag those conversations in pre-IND and scientific advice requests.

2. Standardize safety and data flows across sites

Harmonizing safety reporting across multinational sites reduces noise and speeds timelines. Define a single safety taxonomy, set universal adverse event windows, and train remote assessors on grading standards. Use centralized safety dashboards that integrate EHR extracts and patient-reported outcomes to detect signals fast, while preserving site accountability for local reporting timelines.

3. Design RWE plans that support label expansion

Submitting real-world evidence for label expansion is not optional for many late-phase programs. Create prospective RWE collection plans that specify source validation, linkage methods, and statistical approaches. Engage regulators with predefined case studies that show how registry or claims data complement randomized results, and prepare transparent data lineage documentation for auditability.

4. Fast-track oncology paths with robust remote endpoints

Operationalizing accelerated oncology approval pathways means demonstrating meaningful benefit quickly while managing risk. Use remote imaging reads, digital biomarkers, and home-based labs where validated. Pre-specify when remote assessments can substitute clinic visits and agree those rules with regulators. Market research insights show that patients — including parents of children with developmental disorders caring for family members — appreciate reduced travel burden, which can support retention.

Recent market research indicates growing patient preference for accessible, home-based trial activities, especially among caregivers balancing clinical visits and daily responsibilities.

5. Anticipate the patient and site experience

What to expect during a clinical trial

Expect an initial screening that may combine remote questionnaires, local lab work, and a brief clinic visit. Consent, training on devices, and routine safety checks can be virtual, while certain interventions or assessments remain site-based. Many patients find clinical trials through dedicated platforms that match their condition with relevant studies, helping families discover suitable opportunities without a long search.

• Regulatory guidance: FDA, EMA, MHRA portals
• Decentralized trial toolkits: ICH eCTD and digital health guidance
• Patient advocacy: groups for oncology and developmental disorders
• Trial registries: ClinicalTrials.gov and regional registries
• Data standards: CDISC and HL7 FHIR resources

Integrating decentralized trials with regulators is iterative. Start with clear data standards, document remote endpoint validity, and build safety harmonization into your operating model. With market insight and early regulator engagement you can accelerate approvals, expand labels with RWE, and make trials more accessible for all participants and caregivers.