Citations

Ultrahigh-field 7-T MRI offers superior resolution and contrast, which enable improved detection of subtle neuroanatomic abnormalities and disease-specific imaging biomarkers, with established clinical applications across a broad range of neurologic disorders.

Importance Molecular analyses of biospecimens collected from study participants are essential for identifying biomarkers that can tailor treatments to specific subsets of patients who are most likely to benefit. Sharing of data and biospecimens from clinical trials enables personalized, patient-centric use of cancer therapies and accelerates the development of new treatments. Objective To describe obstacles to sharing data and biospecimens and to propose strategies to enhance access and collaboration. Evidence Review This is a Special Communication authored by 53 academic investigators and patient representatives from the breast cancer community with extensive experience in conducting clinical and translational research. The article also evaluates the impact of biomarker research on specifying responsive subpopulations in the 29 registrational clinical trials that have led to approval of a new drug for treatment of breast cancer between 2017 and 2024. Findings Clinical trial participants are increasingly asked to provide tissue and/or body fluid biospecimens for biomarker research that is typically controlled by the sponsoring pharmaceutical company, but published biomarker studies are rare. Among 29 breast cancer registrational studies reported in the past 8 years, none resulted in biomarker research that restricted a drug’s approved indication. Herein, strategies to maximize the value of clinical data and biospecimens contributed by participants are proposed, thereby supporting the shared goals of the pharmaceutical industry and academia to improve patient care. These strategies include (1) establishing coleadership structures involving academia and patients in clinical trial design and conduct, (2) ensuring that informed consent forms state that data and biospecimens will be shared with academia for future research, (3) requiring the sharing of clinical data as a condition for regulatory approval, and (4) enabling access to biospecimens and translational research data for independent studies on biomarkers that may indicate drug efficacy and toxicity. Conclusions and Relevance Data and biospecimen sharing from registrational trials has been suboptimal. Improving clinical data, biospecimens, and biospecimens’ related data sharing requires concrete actions and a multidimensional stakeholder approach to accelerate the impact of clinical cancer research on the quality of patient care.

OBJECTIVES: Vasoplegia is a common complication of cardiac surgery that uses cardiopulmonary bypass and contributes to morbidity and mortality, yet a consensus definition does not exist. The objective of this study was to evaluate the diagnostic criteria and definitions used to characterize vasoplegia and how different criteria influence incidence estimates. DATA SOURCES: Ovid Embase, Ovid MEDLINE, Scopus, Web of Science Core Collection, ClinicalTrials.gov, Ovid Cochrane Central Register of Controlled Trials, and the World Health Organization’s International Clinical Trials Registry Platform clinical trials registry. STUDY SELECTION: Randomized clinical trials and observational studies reporting on vasoplegia in adults undergoing any type of cardiac surgery that used cardiopulmonary bypass. DATA EXTRACTION: Proportional meta-analysis using a random-effects model and the inverse variance method was used to calculate the pooled incidence of vasoplegia and its clinical outcomes. DATA SYNTHESIS: A total of 68 studies encompassing 56,580 patients were identified, from which 63 unique vasoplegia definitions were used. Blood pressure ( n = 57 studies, 84%) and cardiac output ( n = 50 studies, 74%) were among the most common criteria used in vasoplegia definitions; however, there was a vast variety of threshold values applied within these criteria and all other criteria comprising the definitions. The pooled incidence of vasoplegia was 21% (95% CI, 17–25%), acute kidney injury was 32% (95% CI, 21–45%), and mortality was 12% (95% CI, 9–16%). Subgroup analysis revealed that transplantation and left ventricular assist device implantation surgeries, and those with baseline left ventricular ejection fraction less than 40% had a significantly greater incidence of vasoplegia. CONCLUSIONS: The published literature varies greatly in the criteria used to define vasoplegia associated with on-pump cardiac surgery. Generation and adoption of a unified definition for vasoplegia must be an international priority.

Increased epicardial adipose tissue attenuation on CT images was associated with the presence and recurrence of atrial fibrillation in studies using consistent or corrected tube voltage settings, suggesting its potential as a prognostic marker.

Living donor liver transplantation (LDLT) is a life-saving procedure for patients with end-stage liver disease. As its use expands worldwide, ensuring the safety and well-being of live liver donors (LLD) is of paramount importance. Published evidence on early postoperative complications after living donor hepatectomy—those occurring within 90 days of surgery—is limited, and standardized postoperative care protocols are lacking. The International Liver Transplantation Society (ILTS) and the International Living Donor Liver Transplantation Group (iLDLT Group) convened a consensus conference in Toronto in March 2025 to develop guidelines for the safe care of the LLDs. This manuscript details the recommendations on early postoperative considerations for the safety of LLDs developed by Working Group III (WGIII) of the Consensus Scientific Committee, using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system for assessment of recommendations, and the Danish model of consensus. WGIII addressed four key areas: (1) standardized postoperative care, (2) early biliary complications, (3) early postoperative liver dysfunction, and (4) early postdischarge follow-up. This report emphasizes the need for vigilant postoperative monitoring in specialized units, with access to experienced providers and defined clinical pathways. Structured clinical and psychosocial follow-up protocols, perioperative prophylaxis for surgical site infections and venous thromboembolism, and management of early biliary and vascular complications are discussed. These may help standardize care, reduce complications and improve short-term outcomes in LLDs.

Living liver donation is a critical component for addressing organ shortage and improving outcomes for patients with end-stage liver disease. As the prevalence of living donor liver transplantation (LDLT) increases worldwide, understanding and optimizing long-term donor health is paramount. The 2025 International Liver Transplantation Society and International Living Donor Liver Transplantation Society (ILTS-iLDLT) Consensus Conference convened experts in the field of liver transplantation to establish evidence-based guidelines focused on the long-term medical, psychological, and social considerations following living liver donation. The aim of this working group was to integrate current evidence and expert consensus on donor follow-up protocols, risk assessment, and management strategies to promote long-term donor health, quality of life, and living liver donor programs globally to safeguard the welfare of this unique population.

Regenerative medicine is transforming how we restore tissue function, leveraging advances in cell and molecular biology, biomaterials, and engineered microenvironments. While there have been notable advances and rapid progress over the past few decades, ongoing challenges persist in the technical development and effective translation of these advancements to clinical care. This perspective highlights clinically promising examples and critically assesses present challenges in translating tissue regenerative medicine therapies from the bench to the clinic. We further examine the evolving landscape of regenerative medicine by describing strategies to optimize the cellular microenvironment, the impact of patient demographics, and the use of artificial intelligence to shape the future of this field.