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, both national and international, frequently contributing rigorous statistical frameworks including pre-registered protocols and 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. We have acquired special expertise in implementation science, 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.

9
Randomised Trials
8
Implementation Studies
~50,000
Randomised Patients
17
Countries
>120
Centres
5
DSMBs

Clinical Trials

Randomised controlled trials where I contributed as PI, trialist or lead statistician, including traditional and adaptive designs, frequentist and Bayesian frameworks.

CON-
NECT
CONNECT: Patient Characterization Panel to Improve Satisfaction With the Intensive Care Unit Stay Ongoing
Design: Stepped-wedge cluster RCT, open-label, multicentre, N = 966 patients (target)  ·  Role: Co-PI / Steering Committee / Trialist  ·  Setting: 6 ICUs  ·  Period: 2026-2028
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: 2024-2026
NoVa
NoVa: Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor-Dependent Sepsis Ongoing
Design: Multicentre, open-label, randomised controlled trial  ·  Setting: 20 centres  ·  N = 2,800 patients (target)  ·  Role: Steering Committee / Trialist  ·  Period: 2024–
SAFE-
REDUCE
SAFE-REDUCE: SAFEly REDUCE Antimicrobial Consumption in Intensive Care Units (Registry-Embedded trial) Ongoing
Design: Hybrid effectiveness-implementation Type I, stepped-wedge cluster RCT  ·  Setting: 9 ICUs  ·  Platform/Registry: IMPACTO-MR  ·  Role: Steering Committee / Trialist  ·  Period: 2025-2026
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  ·  Period: 2019-2021
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  ·  Period: 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  ·  Period: 2017
WAL-
NUTs
WALNUTs: Walnut Intake and Adolescent Brain Development Completed
Design: Cluster RCT, N = 771 adolescents  ·  Role: Trialist  ·  Setting: 12 high schools  ·  Period: 2016-2017
Gravity-
VAP
Gravity-VAP: Lateral Trendelenburg vs Semirecumbent Position for VAP Prevention Completed - Stopped Early
Design: Multicentre RCT, N = 395 patients  ·  Role: Methodologist/Trialist  ·  Setting: Multiple European countries  ·  Period: 2010-2015
Implementation Science

Implementation science asks not just what works in trials, but how proven interventions can be delivered equitably at scale, in hospitals and communities that need them most. Our work spans vaccine delivery and infectious disease prevention in vulnerabilised urban settings, and quality improvement in emergency and critical care globally.

We draw on rigorous methodological frameworks, including Hybrid Effectiveness-Implementation Trial Designs and the Consolidated Framework for Implementation Research (CFIR), while embracing innovative and creative approaches that go beyond standard templates: partnering with local organisations, embedding community health workers, co-designing data collection tools with frontline staff, and adapting interventions to resource-constrained realities. We work with communities, clinicians and stakeholders.

Community-based interventions
Dengue
Dengue Vaccine: Community-Based Campaign, Dourados Ongoing
Setting: Dourados, Mato Grosso do Sul, Brazil (~250,000 inhabitants)  ·  Role: Researcher / Epidemiologist  ·  Design: Implementation study + prospective cohort for VE estimation · Period: 2024-
Wol-
bachia
Wolbachia Campo Grande: Large-Scale Release of Wolbachia Mosquitoes on Dengue Incidence Completed
Design: Ecological study, neighbourhood-level interrupted time series  ·  Role: Epidemiologist / External Evaluator  ·  Setting: Campo Grande, Brazil (first federal Wolbachia deployment)  ·  Period: 2020-2024
Vacina
Maré
#VacinaMaré: Community-Based Mass Vaccination Campaign & Embedded Vaccine Effectiveness Study Completed
Setting: Maré favela complex, Rio de Janeiro, Brazil  ·  Role: Scientific Coordinator / Implementation Scientist  ·  Design: Implementation study + embedded test-negative VE study  ·  N: >36,000 residents vaccinated  ·  Period: 2021-2022
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: Asia & Africa, CCAA Network  ·  Period: 2025-2026
AIR
AIR: Implementation of a Family-Led Discharge Intervention for Tracheostomised ICU Survivors in India Analysis Phase
Design: Multicentre Hybrid Type II implementation-effectiveness study, N = 427 patients  ·  Role: Methodologist / Implementation Scientist  ·  Setting: 4 hospitals  ·  Period: 2024–2025
ICU
Triage
ICU Triage: Implementation of a Decision-Aid Tool for ICU Admission Triage Completed
Design: Prospective before-after study, Tertiary Hospital, 110 ICU beds, N = 2,374 urgent referrals  ·  Role: Researcher  ·  Setting: Tertiary hospital network, Brazil  ·  Period: 2014-2015
Light
Sedat.
Sedation Quality Improvement: Minimal Sedation Protocol Using ICU Sedative Consumption as a Monitoring Tool Completed
Design: Quality improvement multicentre project, interrupted time series, 10 ICUs, N = 22,963 patients  ·  Role: Implementation scientist  ·  Setting: AMIL network, Brazil  ·  Period: 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 / Methodologist  ·  Setting: AMIL network, Brazil  ·  Period: 2010–2012

Where have we been working?
World map of trial and implementation countries

Countries involved in clinical trials and implementation science work (n = 17).

Data Safety Monitoring Board (DSMB) Memberships

As an expert, I have contributed to independent DSMBs, either as chair, trialist or statistician. My role is to protect participant safety, guarantee high methodological and ethical standards, 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, multicentre  ·  Setting: 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  ·  Condition: Acute respiratory failure (5 patient groups)
REVO-
LUTIOn
REVOLUTIOn Trial DSMB Member 2021-2022
Design: Phase II/III adaptive multi-arm RCT, 255 participants  ·  Setting: 35 centres  ·  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  ·  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.