Expert Advice: Empathy, PROs & Caregivers in Decentralized Trials

I still remember Maria's voice on the first consent call: hesitant, tired, protective of the family routines that anchored her days. She was considering a decentralized neurology study and worried about travel, the forms, and how her husband would help. The trial team didn’t hand her a PDF and walk away. They practiced implementing empathy-driven informed consent — a short video, a phone check-in, and a caregiver-friendly summary — and Maria agreed to join because she felt seen.

Why empathy matters in decentralized trials

When teams design around life, not clinic schedules, enrollment and retention follow. A lead clinical data manager once told me that consent is the first data quality checkpoint: if participants understand procedures and burdens, the downstream data is cleaner. Recent regulatory guideline updates — think FDA guidance on electronic informed consent and pandemic-era decentralized trial recommendations, alongside ICH E6 revisions emphasizing patient-centricity — reinforce that empathy is not optional; it's expected.

Example: Consent that stayed with a family

A mid-size oncology study piloted an empathy-driven consent workflow: short animated explainer, plain-language one-page summary, and an optional caregiver call. Retention improved by 18% in the first six months. The team credited the change to repeated touchpoints that respected participants' time and emotional load rather than to incentives.

Measuring burden: PROs as a compass

Measuring participant burden with PRO tools gives teams a real-time compass. Tools such as PROMIS or condition-specific PRO-CTCAE capture fatigue, travel strain, and cognitive load. A Parkinson’s decentralized trial used weekly PRO check-ins to flag worsening mobility and reduce unnecessary site visits; participants reported feeling heard, and missing-data rates dropped. Clinical data managers play a key role here: they validate timestamps, ensure adaptive PRO schedules don’t create additional burden, and translate noisy responses into actionable alerts for clinicians and coordinators.

Optimizing decentralized visits to reduce travel

Optimizing decentralized visits to reduce travel is part logistics, part human judgment. One cardiology study replaced quarterly site visits with targeted remote assessments plus one annual in-person visit. For participants in rural counties that meant cutting eight hours of travel annually — a change that converted many tentative candidates into active participants. Operationally, this requires clear SOPs for remote vitals, validated devices, and contingency plans when tech fails. But narratively, it’s about telling prospective participants: we value your time and will only ask you to come in when it matters.

Integrating caregivers into communication

Integrating caregivers into study communication plans changes the story for families. Caregivers often track meds, ferry patients to appointments, and interpret symptoms. When teams include caregiver consent options, tailored updates, and caregiver-facing PROs, adherence climbs and emergency escalations fall.

"We started sending concise, twice-monthly caregiver summaries and saw fewer missed doses and clearer symptom reports," a study coordinator shared.

What to bring to your first visit

• Photo ID and insurance or study card
• List of current medications (including doses)
• Contact information for your caregiver or emergency contact
• Any wearable device data or symptom diaries you’ve kept
• Questions you want answered — bring them on paper or a phone note

Designing decentralized trials that center empathy, PROs, and caregivers is not a checklist — it’s a mindset. Industry insiders, from clinical data managers to coordinators, are aligning operations with recent guidance so trials meet people where they live. Modern clinical trial platforms help streamline the search and connection process for patients and researchers, and when those platforms are coupled with empathy-driven processes, the result is studies that respect lives and deliver better data.