Comparing the prognostic performance of iBOX and biopsy-proven acute rejection for long-term kidney graft survival.

Biopsy-proven acute rejection (BPAR) occurs in approximately 10% of kidney transplant recipients in the first year, making superiority trials unfeasible. iBOX, a quantitative composite of estimated glomerular filtration rate, proteinuria, antihuman leukocyte antigen donor-specific antibody, and + full/- abbreviated kidney histopathology, is a new proposed surrogate endpoint. BPAR's prognostic ability was compared with iBOX in a pooled cohort of 1534 kidney transplant recipients from 4 data sets, including 2 prospective randomized controlled trials. Discrimination analyses showed mean c-statistic differences between both iBOX compared with BPAR of 0.25 (95% confidence interval: 0.17-0.32) for full iBOX and 0.24 (95% confidence interval: 0.16-0.32) for abbreviated iBOX, indicating statistically significantly higher c-statistic values for the iBOX prognosis of death-censored graft survival. Mean (± standard error) c-statistics were 0.81 ± 0.03 for full iBOX, 0.80 ± 0.03 for abbreviated iBOX, and 0.57 ± 0.03 for BPAR. In calibration analyses, predicted graft loss events from both iBOX models were not significantly different from those observed. However, for BPAR, the predicted events were significantly (P < .01) different (observed: 64; predicted: 70; full iBOX: 76; abbreviated iBOX: 173 BPAR). IBOX at 1-year posttransplant is superior to BPAR in the first year posttransplant in graft loss prognostic performance, providing valuable additional information and facilitating the demonstration of superiority of novel immunosuppressive regimens.

Recent application of direct analysis in real time mass spectrometry in plant materials analysis with emphasis on traditional Chinese herbal medicine.

Direct analysis in real time (DART) represents a new generation of ionization techniques that are used to rapidly ionize small molecules under ambient environments. The combination of DART with various mass spectrometry (MS) instruments allows analyzing multiple plant materials, including traditional Chinese herbal medicines (TCHMs), under simple or no sample treatment conditions. This review discussed the DART principles, including devices, ionization mechanisms, and operation parameters. Typical spectra detected by DART-MS were exhibited and discussed. Numerous applications of DART-MS in the fields of plant material and TCHM analysis were reviewed, including compound identification, biomarker discovery, fingerprinting analysis, and quantification analysis. Besides, modifications and improvements of DART-MS, such as hyphenated application with other separation methods, laser-based desorption techniques, and online sampling configuration, were summarized as well.

Qualification of a LC-HRMS platform method for biosimilar development using NISTmab as a model.

Biosimilars are a cost-effective alternative to biopharmaceuticals, necessitating rigorous analytical methods for consistency and compliance. Liquid chromatography coupled with high-resolution mass spectrometry (LC-HRMS) is a versatile tool for assessing key attributes, encompassing molecular mass, primary structure, and post-translational modifications (PTMs). Adhering to ICH Q2R1, we validated an LC-HRMS based peptide mapping method using NISTmab as a reference. The method validation parameters, covering system suitability, specificity, accuracy, precision, robustness, and carryover, were comprehensively assessed. The method effectively differentiated the NISTmab from similar counterparts as well as from artificially introduced spiked conditions. Notably, the accuracy of mass error for NISTmab specific complementarity determining region peptides was within a maximum of 2.42 parts per million (ppm) from theoretical and the highest percent relative standard deviation (%RSD) observed for precision was 0.000219 %. It demonstrates precision in sequence coverage and PTM detection, with a visual inspection of total ion chromatogram approach for variability assessment. The method maintains robustness when subjected to diverse storage conditions, encompassing variations in column temperature and mobile phase composition. Negligible carryover was noted during the carryover analysis. In summary, this method serves as a versatile platform for multiple biosimilar development by effectively characterizing and identifying monoclonal antibodies, ultimately ensuring product quality.

Impact of the endoscopic surgical skill qualification system on the oncological safety of laparoscopic gastrectomy for gastric cancer: A single-center retrospective cohort study.

BACKGROUND: This study aimed to investigate the laparoscopic gastrectomy (LG) performance of non-Endoscopic Surgical Skill Qualification System (ESSQS)-qualified surgeons under the ESSQS-qualified surgeon guidance and compare oncological outcomes of gastric cancer to LG performed by the ESSQS-qualified surgeons. METHODS: This study enrolled 1,030 patients diagnosed with both clinical and pathological stage ≤ III gastric cancer and undergoing LG from January 2009 to June 2019. ESSQS-qualified surgeons served as the operator or the instructive assistant in all LG procedures involving them. A propensity score-matched analysis was used to retrospectively compare the long-term outcomes between the ESSQS-qualified and non-ESSQS-qualified surgeons. RESULTS: Each group included 315 pairs after propensity score matching. The 3-year recurrence-free survival rates were 84.4% and 81.7% in the non-ESSQS and ESSQS groups, respectively. The difference was 2.7% (95% confidence interval: - 3.20%-8.44%, P < 0.001), and the non-ESSQS group statistically demonstrated noninferiority as the lower 95% confidence limit was greater than the prespecified margin of -10%, indicating the achieved primary endpoint. No significant differences in 5-year recurrence-free survival (non-ESSQS: 78.5% vs. ESSQS: 77.4%, P = 0.627) and 5-year overall survival (non-ESSQS: 80.9% vs. ESSQS: 79.3%, P = 0.475) were found between the two groups. The oncological outcomes stratified according to the presence of pathological stage I, II, and III disease did not significantly differ between the two groups. CONCLUSIONS: LG performed by non-ESSQS-qualified surgeons achieved comparable oncological outcomes to the ESSQS-qualified surgeons, as long as ESSQS-qualified surgeons provided intraoperative instructions, in a high-volume center.

Impact of the endoscopic surgical skill qualification system on conversion to laparotomy after low anterior resection for rectal cancer in Japan (a secondary analysis of the EnSSURE study).

BACKGROUND AND AIMS: Conversion to laparotomy is among the serious intraoperative complications and carries an increased risk of postoperative complications. In this cohort study, we investigated whether or not the Endoscopic Surgical Skill Qualification System (ESSQS) affects the conversion rate among patients undergoing laparoscopic surgery for rectal cancer. METHODS: We performed a retrospective secondary analysis of data collected from patients undergoing laparoscopic surgery for cStage II and III rectal cancer from 2014 to 2016 across 56 institutions affiliated with the Japan Society of Laparoscopic Colorectal Surgery. Data from the original EnSSURE study were analyzed to investigate risk factors for conversion to laparotomy by performing univariate and multivariate analyses based on the reason for conversion. RESULTS: Data were collected for 3,168 cases, including 65 (2.1%) involving conversion to laparotomy. Indicated conversion accounted for 27 cases (0.9%), while technical conversion accounted for 35 cases (1.1%). The multivariate analysis identified the following independent risk factors for indicated conversion to laparotomy: tumor diameter [mm] (odds ratio [OR] 1.01, 95% confidence interval [CI] 1.01-1.05, p = 0.0002), combined resection of adjacent organs [+/-] (OR 7.92, 95% CI 3.14-19.97, p < 0.0001), and surgical participation of an ESSQS-certified physician [-/+] (OR 4.46, 95% CI 2.01-9.90, p = 0.0002). The multivariate analysis identified the following risk factors for technical conversion to laparotomy: registered case number of institution (OR 0.99, 95% CI 0.99-1.00, p = 0.0029), institution type [non-university/university hospital] (OR 3.52, 95% CI 1.54-8.04, p = 0.0028), combined resection of adjacent organs [+/-] (OR 5.96, 95% CI 2.15-16.53, p = 0.0006), and surgical participation of an ESSQS-certified physician [-/+] (OR 6.26, 95% CI 3.01-13.05, p < 0.0001). CONCLUSIONS: Participation of ESSQS-certified physicians may reduce the risk of both indicated and technical conversion. Referral to specialized institutions, such as high-volume centers and university hospitals, especially for patients exhibiting relevant background risk factors, may reduce the risk of conversion to laparotomy and lead to better outcomes for patients. TRIAL REGISTRATION: This study was registered with the Japanese Clinical Trials Registry as UMIN000040645.

Community interpreting in Germany: results of a nationwide cross-sectional study among interpreters.

BACKGROUND: Community interpreters (CIPs) play a crucial role in various community services, including healthcare, when service providers and users do not share a common language. However, there is a lack of evidence-based data on this population globally. This explorative cross-sectional study aims to gain a better understanding of CIPs and their work in Germany. METHODS: A nationwide online survey was conducted among CIPs in Germany to collect data on their qualification background, working conditions, mental health, interpreting-related psychosocial distress and sociodemographics. Participants were recruited through interpreting pools, training institutions and migrant organizations. Data were analyzed descriptively, dependent t-test, multiple logistic and hierarchical stepwise regression analyses were performed to predict participation in interpreting-specific training, interpreting competence and interpreting-related psychosocial distress. RESULTS: Across all 16 federal states, N = 873 responses were used for analysis. Most participants are female (74%), born abroad (77%) and have a high level of education (69%). The vast majority interpret occasionally in their leisure time (44%) and are self-employed/freelance (51%). 34% interpret solely or additional on a voluntary basis (unpaid). The median hours of interpreting per month are 10 h, 75% do not exceed 30 h. On average interpreters work in four different settings. 69% attended any kind of interpreting training with a median of 25 h in total. Interpreting in more settings emerged as an associated factor with participation in training. Of those who have never attended any training, 69% consider themselves as rather/very competent in interpreting. Interpreting more frequently, having less severe anxiety symptoms, getting higher and more often paid and being less satisfied with the payment is associated with self-reported interpreting competence. In total, 36% reported moderate or severe psychosocial distress regarding interpreting. Higher general psychosocial distress and depressive symptoms, higher interpreting frequency and lower payment satisfaction were found to be associated with higher distress regarding interpreting. Additionally, factors such as precarious work conditions, lack of recognition and discrimination (e.g. racism and sexism) were reported as distressing. CONCLUSION: This study provides a first comprehensive evidence-based national database on CIPs in Germany. The findings can be valuable for the development of qualifications, guidelines, policies and the process of professionalizing the field of CIPs.

Analysis of non-mutagenic substances in the context of drug impurity assessment - Few are potent toxicants.

ICH Q3A/B guidelines provide qualification thresholds for impurities or degradation products in new drug substances and products. However, the guidelines note that certain impurities/degradation products may warrant further safety evaluation for being unusually potent or toxic. The purpose of this study was to confirm that especially toxic non-mutagenic compounds are rare and to identify classes of compounds that could warrant lower qualification thresholds. A total of 2815 compounds were evaluated, of which 2213 were assessed as non-mutagenic. For the purpose of this analysis, compounds were considered potent when the point of departure was ≤0.2 mg/kg/day based on the qualification threshold (1 mg/day or 0.02 mg/kg/day for a 50 kg human) in a new drug substance, with an additional 10-fold margin. Only 54 of the entire set (2.4%) would be considered potent based on this conservative potency analysis, confirming that the existing ICH Q3A/B qualification thresholds are appropriate for the majority of impurities. If the Q3A/B threshold, without the additional 10-fold margin is used, 14 compounds (0.6%) are considered "highly potent". Very few non-mutagenic structural classes were identified, including organothiophosphates and derivatives, polychlorinated benzenes and polychlorinated polycyclic aliphatics, that correlate with potential high potency, consistent with prior publications.

Deriving acceptable limits for non-mutagenic impurities in medicinal products - Durational adjustments.

ICH Q3A/B guidelines are not intended for application during the clinical research phase of development and durationally adjusted qualification thresholds are not included. A central tenet of ICH Q3A is that lifetime exposure to 1 mg/day of an unqualified non-mutagenic impurity (NMI) is not a safety concern. An analysis of in vivo toxicology data from 4878 unique chemicals with established NO(A)ELs was conducted to determine whether durationally adjusted qualification limits can be supported. Although not recommended in ICH Q3A/B, a conservative approach was taken by using allometric scaling in the analysis. Following allometric scaling of the 5th percentile of the distribution of NO(A)ELs from available chronic toxicology studies, it was reconfirmed that there is a safety basis for the 1 mg/day qualification threshold in ICH Q3A. Additionally, allometric scaling of the 5th percentile of the distribution of NO(A)ELs from sub-acute and sub-chronic toxicology studies could support acceptable limits of 20 and 5 mg/day for an unqualified NMI for dosing durations of less than or greater than one month, respectively. This analysis supports durationally adjusted NMI qualification thresholds for pharmaceuticals that protect patient safety and contribute to 3Rs efforts for qualifying impurities using new approach methods.

Non-mutagenic impurities - Recent industry experience of using dose durational limits in drug development.

Absence of clear guidance on the qualification threshold for non-mutagenic impurities during clinical development is a source of inconsistency in both sponsor qualification approaches and health authority requests. A survey was conducted in March 2020 with 6 member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Thirteen examples were gathered of where non-International Council for Harmonisation (ICH) limits have been used in regulatory submissions for various indications and stages of development, together with the regulatory outcomes. As expected, few challenges were faced in early clinical development, with health authorities generally commenting that sponsors should work towards ICH Q3A and Q3B guideline specification limits as development progresses. However, inconsistent health authority requests were noted even for early phase clinical trials in late-stage oncology patients. For an optimised use of resources, consistent approaches would have the benefit of supporting faster access of safe medicines to patients while including Replacement, Reduction and Refinement (the 3Rs) considerations with respect to animal testing.

New limits proposed for the management of non-mutagenic impurities.

Multiple international guidelines exist that describe both quality and safety considerations for the control of the broad spectrum of impurities inherent to drug substance and product manufacturing processes. However, regarding non-mutagenic impurities (NMI) the most relevant ICH Q3A/B guidelines are not applicable during early phases of drug development leading to confusion about acceptable limits at this stage. Thus, there is need for more flexible approaches that ensure that patient safety remains paramount, while taking into consideration the limited duration of exposure. An EFPIA survey, which collected quantitative data from different types of studies applied to qualify impurities in accordance with ICH Q3A, shows that no toxicities could be attributed to any of the 467 impurities at any tested level in vivo. This data combined with earlier published toxicological datasets encompassing drug substances and intermediates, food related substances and chemicals provide convincing evidence that for NMIs, the application of a generic 5 mg/day limit for an exposure duration <6 months, and a 1 mg/day generic limit for life-long exposure, provides sufficient margins to ensure patient safety. Hence, application of these absolute limits to trigger qualification studies (instead of the relative limits described in Q3A/B), is considered warranted. This approach will prevent conduct of unnecessary dedicated impurity qualification studies and the resulting use of animals.

Influence of Physical Attractiveness and Gender on Patient Preferences in Digital Doctor Consultations: Experimental Study.

BACKGROUND: The rise of digital health services, particularly digital doctor consultations, has created a new paradigm in health care choice. While patients traditionally rely on digital reviews or referrals to select health care providers, the digital context often lacks such information, leading to reliance on visual cues such as profile pictures. Previous research has explored the impact of physical attractiveness in general service settings but is scant in the context of digital health care. OBJECTIVE: This study aims to fill the research gap by investigating how a health care provider's physical attractiveness influences patient preferences in a digital consultation setting. We also examine the moderating effects of disease severity and the availability of information on health care providers' qualifications. The study uses signal theory and the sexual attribution bias framework to understand these dynamics. METHODS: Three experimental studies were conducted to examine the influence of health care providers' physical attractiveness and gender on patient preferences in digital consultations. Study 1 (n=282) used a 2×2 between-subjects factorial design, manipulating doctor attractiveness and gender. Study 2 (n=158) focused on women doctors and manipulated disease severity and participant gender. Study 3 (n=150) replicated study 2 but added information about the providers' abilities. RESULTS: This research found that patients tend to choose attractive doctors of the opposite gender but are less likely to choose attractive doctors of the same gender. In addition, our studies revealed that such an effect is more prominent when the disease severity is high. Furthermore, the influence of gender stereotypes is mitigated in both the high and low disease severity conditions when service providers' qualification information is present. CONCLUSIONS: This research contributes to the literature on medical information systems research and sheds light on what information should be displayed on digital doctor consultation platforms. To counteract stereotype-based attractiveness biases, health care platforms should consider providing comprehensive qualification information alongside profile pictures.

A surgical training system designed to help trainees acquire laparoscopic surgical skills at a rural Japanese institute.

PURPOSE: The Endoscopic Surgical Skill Qualification System was established in Japan to evaluate safe endoscopic surgical techniques and teaching skills. Trainee surgeons obtaining this certification in rural hospitals are disadvantaged by the limited number of surgical opportunities. To address this problem, we established a surgical training system to educate trainee surgeons. METHODS: Eighteen certified expert surgeons affiliated with our department were classified into an experienced training system group (E group, n = 9) and a non-experienced group (NE group, n = 9). Results of the training system were then compared between the groups. RESULTS: The number of years required to become board certified was shorter in the E group (14 years) than that in the NE group (18 years). Likewise, the number of surgical procedures performed before certification was lower in the E group (n = 30) than that in the NE group (n = 50). An expert surgeon was involved in the creation of the certification video of all the E group participants. A questionnaire to board-certified surgeons revealed that guidance by a board-certified surgeon and trainee education (surgical training system) was useful for obtaining certification. CONCLUSIONS: Continuous surgical training, starting with trainee surgeons, appears useful for expediting their acquisition of technical certification in rural areas.

Modeling and Analyzing the Availability of Technical Professional Profiles for the Success of Smart Cities Projects in Europe.

The success of developing and implementing Smart Cities (SC) projects depends on a varied set of factors, where the availability of a qualified technical workforce is a critical one. The combination of ICT requirements, like the effectiveness and quality of solutions merging IoT, cloud computing, sensors, and communications with the work from many varied disciplines (e.g., civil engineering, architecture, etc.), mixed with aspects of environmental and business sustainability, makes the management of these projects really challenging. Reports forecast a scarcity of qualified candidates, given this complexity and the growth of activity in SC projects. The European project SMACITE has addressed the requirements of the qualification of an ICT workforce with an analysis of multiples sources of information from the labor market, feedback from involved stakeholders, and the literature. The goal was the development of two occupational ICT profiles as a reference for training and for the availability of candidates for job vacancies. The result is two ICT role profiles for engineers and technicians, mapped with the European skills frameworks ESCO and EN16234. The profiles determined the whole set of requirements, including not only the technical areas and soft skills, but also additional technical areas and sustainability and managerial skills and the analysis of different sources of information. Our work has also determined which existing ESCO occupations are similar to the two reference profiles, so they are better adapted to SC projects. The training activities of SMACITE have also suggested the amount of training expected for a varied sample of candidates who want to be qualified for SC projects.

Introduction to qualification and validation of an immunoassay.

Immunoassays play an important role in drug development of products targeting the immune system. Consistent quality of the results from an immunoassay is essential to make unbiased and accurate claims about the drug product during preclinical and clinical development stages. Assay qualification and validation shed light on the performance of the assay. It is the first evaluation and the verification, respectively, of the assay's performance. This tutorial explains and illustrates the calculation methodology for important assay qualification parameters including precision, relative accuracy, linearity, the lower limit of quantification (LLOQ), the upper limit of quantification (ULOQ), the assay range and dilutability. This tutorial focuses on assays used for (pre-) clinical purposes, characterized by a lognormal distribution of the measurements on its original untransformed scale and by the lack of well characterized reference material. Statistical calculations are illustrated with qualification data from an enzyme-linked immunosorbent assay (ELISA) vaccine immunoassay.

Tooth Wear Evaluation System 2.0-Evaluation of diagnostic reliability in the assessment of signs and symptoms for tooth wear by non-experts.

BACKGROUND: Tooth wear is a multifactorial condition that manifests through various signs and symptoms. These individual signs and symptoms were described in multiple studies, leading to the inclusion in TWES 2.0 (Tooth Wear Evaluation System 2.0) and the forthcoming DC-TW (Diagnostic Criteria for Tooth Wear). However, a study evaluating their reliability has yet to be conducted. OBJECTIVE: The aim of the study was to examine the reliability in the assessment of 6 signs of pathological tooth wear and 18 clinical signs and symptoms determining aetiology, all of which are included in the TWES 2.0/DC-TW. METHODS: 48 dental students (operators) evaluated patient cases from a patient pool of 14 patients on dental casts and high-resolution intraoral photographs. The agreement between all operators for each sign and symptom was calculated based on ICC (Intraclass Correlation Coefficients). Additionally, the agreement of each operator's evaluation with a predefined sample solution was calculated based on Cohen's kappa. RESULTS: Inter-user agreement ranged from near perfect (0.91) to poor (0.02) for the various pathology signs or aetiology symptoms of tooth wear (mean 0.32). The agreements of the operator's ratings compared to the sample solution resulted in Cohen's kappa from 0.18 to 1 (mean 0.59) for the pathology signs and ranged from 0.02 to 0.51 for the aetiology signs (mean 0.38). CONCLUSIONS: The reliability of the signs and symptoms examined and the ability of individual investigators to correctly identify and assign signs and symptoms varied widely. The current assessment tools for the qualification of tooth wear need further refinement, and examiners need intensive training in tooth wear assessment.

[Use of AI-based applications by hospital staff: task profiles and qualification requirements]. / Einsatz von KI-basierten Anwendungen durch Krankenhauspersonal: Aufgabenprofile und Qualifizierungsbedarfe.

BACKGROUND: Artificial intelligence (AI) is becoming increasingly important for the future development of hospitals. To unlock the large potential of AI, job profiles of hospital staff members need to be further developed in the direction of AI and digitization skills through targeted qualification measures. This affects both medical and non-medical processes along the entire value chain in hospitals. The aim of this paper is to provide an overview of the skills required to deal with smart technologies in a clinical context and to present measures for training employees. METHODS: As part of the "SmartHospital.NRW" project in 2022, we conducted a literature review as well as interviews and workshops with experts. AI technologies and fields of application were identified. RESULTS: Key findings include adapted and new task profiles, synergies and dependencies between individual task profiles, and the need for a comprehensive interdisciplinary and interprofessional exchange when using AI-based applications in hospitals. DISCUSSION: Our article shows that hospitals need to promote digital health literacy skills for hospital staff members at an early stage and at the same time recruit technology- and AI-savvy staff. Interprofessional exchange formats and accompanying change management are essential for the use of AI in hospitals.

Medical examinations of professional and amateur athletes at a sports medicine clinic. Insights from a sports medicine specialist and cardiologist.

In 2019, three regulations of the Minister of Health regarding sports medicine examinations in children, adolescents and young athletes came into force. The publication presents in detail the current scope of tests and the frequency of required medical examinations necessary to obtain medical certificates qualify- ing patients to practice sports. The publication also presents the Regulation of the Minister of Health on the required qualifications of doctors authorized to issue medical certificates to athletes. It is very important to properly assess the health of potential and current athletes to ensure their safety while participating in sports competitions. There are diseases that increase the risk of sudden cardiac death which doctors should keep in mind when qualifying athletes for competition. The publication draws attention to the underestimated role of echocardiography and electrocardiographic stress testing.

[Nursing skill levels and implementation of Advanced Nursing Practice in Austria: A cross-sectional study]. / Pflegerische Qualifikationsniveaus und Umsetzung von Aufgaben für eine Advanced Nursing Practice in Österreich.

Nursing skill levels and implementation of Advanced Nursing Practice in Austria: A cross-sectional study Abstract: Background: New fields of practice are emerging under the concept of "Advanced Nursing Practice" (ANP) that offer specialised care provided by nurses who hold master's degrees. In Austria, nurses are currently being trained as Advanced Practice Nurses (APN). Aim: The project aimed to investigate which advanced nursing practice tasks according to the Hamric model are undertaken by nurses at different levels of qualification in Austria. Methods: Certified nurses did participate in a cross-sectional survey through an online questionnaire based on the Role Delineation Model and tailored to the Austrian context. The tasks were assigned based on the Hamric model and were tested and evaluated descriptively according to the qualification level through factor analysis. Results: Completed data was available from 105 participants, among them 80% with undergraduate education, 20% with a master's degree. A tendency in the results showed that the level of qualification was related to the activities carried out. The higher the academic degree, the more activities were performed in the field of leadership. The central ANP-competencies, research and education, are rather weak among all respondents. Conclusion: The results show that activities corresponding to the competencies of an ANP are performed by a heterogeneous group of nurses. Conditions and a standardized understanding of ANP need to be established in order to offer a professional practice that matches the competency profile.

[The impact of public organizations on development of professional qualification of medical workers].

The professional development of personnel is one of highest priority task of development of both medicine as science and health system as mechanism protecting health of citizens. The public organizations are professional communities of medical specialists specializing in particular sectors of medicine that actively participate in implementation of educational measures and other initiatives targeted to support opportunities for professional growth and improving competence level of participants of these communities. The article considers examples of such initiatives as exemplified by foreign and Russian public organizations of pulmonologists and dentists.

Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes.

New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute's Transplant Therapeutics Consortium received a qualification opinion for the iBOX Scoring System as a novel secondary efficacy endpoint for kidney transplant clinical trials through European Medicines Agency's qualification of novel methodologies for drug development. This is the first qualified endpoint for any transplant indication and is now available for use in kidney transplant clinical trials. Although the current efficacy failure endpoint has typically shown the noninferiority of therapeutic regimens, the iBOX Scoring System can be used to demonstrate the superiority of a new immunosuppressive therapy compared to the standard of care from 6 months to 24 months posttransplant in pivotal or exploratory drug therapeutic studies.