Clinical Trials & Implementation Science

From trial design to real-world delivery

Rigorous Evidence  ·  Equitable Delivery  ·  Community Partnership


Clinical trials are the backbone of evidence-based medicine, but generating evidence and implementing it are two different disciplines: both equally demanding. Our group works across this entire spectrum: co-designing and contributing to interventional trials as investigators, trialists and statisticians/methodologists, and embedding implementation science to ensure findings reach the populations who need them most.

We bring particular expertise in critical care and infectious disease trials, frequently contributing rigorous statistical frameworks including pre-registered statistical analysis plans (SAPs). In parallel, our community-embedded implementation science addresses the gap between what trials show and what actually happens on the ground, particularly in vulnerabilised settings where standard trial infrastructure is absent and community trust must be earned.

Our Data Safety Monitoring Board (DSMB) work gives us experience and a privileged vantage point across a broad portfolio of trials worldwide, informing decisions that directly affect participant safety and the integrity of the evidence base.


🧪 Clinical Trials

Randomised controlled trials where I contributed as PI, co-investigator, trialist or lead statistician, including pre-registered statistical analysis plans and adaptive designs.

🟡 Ongoing / Analysis Phase
TELE-
SCOPE·2
TELESCOPE 2: Evaluation of multifaceted Tele-ICU practices in Brazilian ICUs Analysis Phase
Design: Stepped-wedge cluster RCT, open-label, multicentre  ·  Role: Scientific coordinator / Trialist  ·  Setting: 25 ICUs  ·  Period: Jan 2024 - Jan 2026
✅ Completed Clinical Trials
TELE-
SCOPE
TELESCOPE: Tele-Critical Care vs Usual Care on ICU Performance Completed
Design: Parallel cluster RCT with baseline period, N = 15,230 patients  ·  Role: CO-PI  ·  Setting: 30 ICUs  ·  2019-2021
Gravity-
VAP
Gravity-VAP: Lateral Trendelenburg vs Semirecumbent Position for VAP Prevention Completed — Stopped Early
Design: Multicenter RCT, N = 395 patients  ·  Role: Methodologist/Trialist  ·  Setting: Multi-european countries and others  ·  2010-2015
V-TRI-
AGE
V-TRIAGE: Impact of Nonclinical Factors on ICU Admission Decisions Completed
Design: Randomised factorial vignette trial, N = 125 intensivists  ·  Role: Co-Investigator  ·  Setting: Brazil  ·  2021
Blue
Space
Blue Space Trial: Physical and Mental Health Effects of Repeated Short Walks in Blue Spaces Completed
Design: Randomised crossover study, N = 59 participants  ·  Role: Trialist  ·  Setting: Barcelona, Spain  ·  2020

🏘️ Implementation Science

Implementation science addresses the gap between evidence and practice — asking not just what works in trials, but how proven interventions can be delivered equitably at scale, in the communities that need them most. Our work in this domain has focused on vaccine delivery and infectious disease prevention in vulnerabilised urban settings, co-designed with communities rather than merely for them.

Vacina
Maré
#VacinaMaré: Community-Based Mass Vaccination Campaign & Embedded VE Study Completed
Setting: Maré favela complex, Rio de Janeiro, Brazil  ·  Role: Co-Investigator / Implementation Scientist  ·  Design: Implementation study + embedded test-negative VE study  ·  N: >36,000 residents vaccinated
TAK-003
Dourados
TAK-003 Dengue Vaccine: Community-Based Campaign, Dourados Completed - Under Evaluation
Setting: Dourados, Mato Grosso do Sul, Brazil (~250,000 inhabitants)  ·  Role: Researcher / Epidemiologist  ·  Design: Implementation study + prospective cohort for VE estimation
🦟 Vector Control
Wol-
bachia
Wolbachia Campo Grande: Large-Scale Release of Wolbachia Mosquitoes on Dengue Incidence Completed - Evaluation Role
Design: Ecological study, neighbourhood-level interrupted time series  ·  Role: Epidemiologist / External Evaluator  ·  Setting: Campo Grande, Brazil (first federal Wolbachia deployment)  ·  2020–2024
🏥 Critical Care Quality Improvement
EQUIPS-
ICU
EQUIPS-ICU: Evidence-Based Quality Improvement for Antimicrobial Stewardship in ICUs Ongoing
Design: Type III hybrid implementation-effectiveness study, 35 ICUs, ≤11 LMICs  ·  Role: Co-Investigator (active)  ·  Setting: Low- and middle-income countries (Africa, Asia, South America)
ICU
Triage
ICU Triage Decision-Aid: Implementation of a Decision-Aid Tool for ICU Admission Triage Completed
Design: Prospective before-after study, 10 ICUs, N = 2,201 referrals  ·  Role: Co-Investigator  ·  Setting: Tertiary hospital network, Brazil  ·  2019
Light
Sedat.
Sedation Quality Improvement: Minimal Sedation Protocol Using ICU Sedative Consumption as a Monitoring Tool Completed
Design: Quality improvement multicenter project, interrupted time series, 10 ICUs, N = 22,963 patients  ·  Role: Lead Investigator (first author)  ·  Setting: AMIL non-teaching hospital network, Brazil  ·  2010–2012
Sepsis
Edu
AMIL Sepsis Program: Multifaceted Sepsis Education & Bundle Implementation Completed
Design: Pre-post multicentre study, 10 hospitals (1,650 beds), N = 2,120 patients  ·  Role: Co-Investigator (2nd author)  ·  Setting: Brazil (private network)  ·  2010–2012

🛡️ Data Safety Monitoring Board (DSMB) Memberships

As an independent DSMB member or chair, my role is to protect participant safety, review accumulating unblinded data on efficacy and harm, and make independent recommendations to trial steering committees — including decisions to stop, modify, or continue a trial.

VATI-
CAN
VATICAN: Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation DSMB Member · Statistician Ongoing
Design: Noninferiority RCT, open-label, multicenter  ·  Setting: Brazil (BRICNet)  ·  Condition: Ventilator-associated tracheobronchitis (ICU)  ·  Period: 2024–present
RENO-
VATE
RENOVATE — High-Flow Nasal Oxygen vs Noninvasive Ventilation in Acute Respiratory Failure DSMB Member 2021–2023
Design: Bayesian adaptive noninferiority RCT, 1,800 participants  ·  Setting: 33 hospitals, Brazil  ·  Condition: Acute respiratory failure (5 patient groups)
REVO-
LUTIOn
COALITION COVID-19 BRAZIL IX — REVOLUTIOn Trial DSMB Member 2021–2022
Design: Phase II/III adaptive multi-arm RCT, 255 participants  ·  Setting: 35 centres, Brazil  ·  Condition: Hospitalised COVID-19 with hypoxaemia
LERON-
LIMAB
Leronlimab in COVID-19 Trial DSMB Chair Halted — Safety
Intervention: Leronlimab (CCR5 antagonist)  ·  Condition: COVID-19  ·  Period: 2021–2022
STOP-
COVID
STOP-COVID — Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia DSMB Chair 2020
Design: Phase III RCT, 1:1, 289 participants  ·  Setting: 15 sites, Brazil  ·  Sponsor: Pfizer  ·  Condition: Hospitalised COVID-19 pneumonia

🧠 Key Principle

Evidence from clinical trials is only as valuable as its reach. We design studies to answer questions that communities already have, and we build the implementation infrastructure to deliver findings where they matter.