Silviane Leite Melo is a general surgeon with fifteen years in trauma and surgical critical care, now working in evidence synthesis. She publishes as first and senior author on comparative analyses of devices and procedures in surgery and critical care.
She is moving into medical affairs in medical technology, working on evidence planning, review of promotional and scientific content, engagement with clinical experts, and post-market evidence.
Embolization has largely replaced surgery for stable blunt splenic injury, but WSES guidelines still route every hemodynamically unstable patient to the operating room. The evidence behind that instruction compared embolization against watchful waiting rather than against the operation, and almost never in unstable patients, who cannot be randomized in an emergency.
Registered the protocol on PROSPERO before screening began, fixing the analysis plan in advance: random-effects REML with Hartung-Knapp correction, a prespecified subgroup at systolic pressure of 90 mmHg or below, ROBINS-I, GRADE. Led six investigators across four countries and wrote a deduplication rule so overlapping national registries did not enter the pooled estimate twice.
Added trial sequential analysis to distinguish a real effect from accumulated random error, and corrected a misreading of the required information size carried in the team's earlier documents.
Mortality was 5.2 percent with embolization against 14.5 percent with surgery, and the cumulative evidence crossed the required information size, so the question does not need another study. The benefit held in the unstable subgroup, with heterogeneity falling from 74 percent to zero.
Length of stay favored embolization but had not reached the required information size and was published as provisional. The thromboembolism benefit disappeared when a single study was removed and was reported as fragile. Certainty was not upgraded despite the large effect, because confounding by indication could not be excluded.
Three of the four findings shipped with an explicit limit on how far they can be stated. That is the difference between an evidence summary a medical reviewer can sign and one that has to be sent back.
Evidence synthesis at scale fails on expert access, not on methodology. The organization needed dependable clinical input across specialties it did not employ, available continuously rather than assembled project by project, and had no structure for obtaining it.
Designed the network and recruited into it, launching in October 2025 with two specialists per specialty so no manuscript depended on one reviewer's availability. Built a nine-person ambassador layer reporting to her, and ran the reporting cycle that made engagement measurable rather than anecdotal.
As participation from outside Brazil reached 16 countries, led the move from Portuguese to English as the operating language and rebuilt the model around it, shifting to shared infrastructure with an opportunities board, specialist spotlight content and sprint integration.
The 17 specialty groups supported roughly 200 manuscripts. The project closed in July 2026 with its scope delivered, having operated in two languages and across 16 countries from a standing start.
A wind-down had been prepared as the alternative. She recommended restructuring instead, and designed the ambassador incentive structure that carried the model through its final cycle.
Expert programs run on structure, not goodwill. This is the same work as recruiting advisors, defining what they contribute, and reporting on it, at multi-country scale and in English.
Physicians entering industry read a drug advertisement as marketing rather than as a document a medical reviewer approved. That gap is where a new medical affairs hire creates compliance risk, and it is rarely closed by teaching the regulations in the abstract.
Built a class around the reviewer's lens, opening with the five FDA-required elements of a consumer product-claim ad, then separating product-claim, reminder and help-seeking advertising by the obligations each carries.
The cohort applies the framework to four real campaigns and their brand websites, each chosen to isolate a different reviewer problem: safety information placement, multiple approved indications, testimonials and copay savings cards as regulated content, and HCP gating in oncology.
Delivered to the Industry Pathway cohort, organized around a single argument: fair balance is the requirement most often technically satisfied and least often actually satisfied, and recognizing that gap is the transferable skill.
On the MLR committee itself, mapping what the medical, legal and regulatory reviewers each own, so the cohort understands which seat they would occupy.
Promotional review is the part of the role clinicians entering industry are least prepared for. This is documented work inside that framework, at the level of specific FDA requirements and specific commercial content.
MD, Escola Bahiana de Medicina e Saúde Pública, 2010. General surgery residency at the Federal University of Bahia. Fifteen years of practice in general surgery, trauma and surgical critical care in Brazil.
PRISMA and the Cochrane Handbook, PROSPERO registration, random-effects models with REML and Hartung-Knapp correction, meta-regression, Bayesian analysis, trial sequential analysis, ROBINS-I and GRADE. R, RevMan, TSA and GRADEpro.
Research Lead at Meta-Analysis Academy since June 2025. Career advisor and monitor for the Industry and Innovation Pathway at the Boston Research Society.
BCMAS (ACMA), CMPP (ISMPP), Advanced Good Clinical Practice (CCRPS) and AI in Healthcare (Johns Hopkins). Member of the Medical Affairs Professional Society.