Availability of results of academic randomized trials involving cooperative groups in oncology in France: A systematic search of clinical trial registries.

Background: Cooperative groups' involvement is increasing in academic oncological research. We aimed to assess the impact of sponsoring by cooperative groups in France on the availability of results of academic randomized trials in oncology.

Methods: We performed a systematic search using ClinicalTrials.

Impact of oxygen tension according to embryo stage of development: a prospective randomized study.

Human embryo culture under 2-8% O2 is recommended by ESHRE revised guidelines for good practices in IVF labs. Nevertheless, notably due to the higher costs of embryo culture under hypoxia, some laboratories perform embryo culture under atmospheric O2 tension (around 20%). Furthermore, recent meta-analyses concluded with low evidence to a superiority of hypoxia on IVF/ICSI outcomes.

Bayesian analysis from phase III trials was underused and poorly reported: a systematic review.

Objectives: We assessed the reporting of replicability items with the BayesWatch guidelines and crucial items of Bayesian analyses with the Reporting Of Bayes Used in clinical STudies (ROBUST) guidelines in reports of phase III trials.

Study Design And Setting: A literature search of Cochrane CENTRAL, Ovid MEDLINE, and EMBASE database was conducted to identify phase III trials using Bayesian methods for their primary outcome. Two reviewers performed the study selection process independently.

A Methodologic Systematic Review of Mobile Health Behavior Change Randomized Trials.

Context: Mobile health helps providers offer accessible, affordable, tailored behavior change interventions. However, research assessing mobile health interventions may feature methodologic shortcomings and poor reporting. This review aims to summarize the characteristics, methods, and intervention reporting of RCTs evaluating mobile health behavior change interventions.

Appraisal of cancer drugs: a comparison of the French health technology assessment with value frameworks of two oncology societies.

Objectives: Our primary objective was to compare the grading of the value of cancer drugs ('Amélioration du Service Médical Rendu' [ASMR] level) by the French health technology assessment authority ('Haute Autorité de santé' [HAS]) with that by the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Our secondary objective was to study the drivers of the French grading system.

Methods: We included new drugs for solid tumors assessed by the HAS between 2010 and 2016 and compared their ASMR level to scores calculated by the 2016-updated ASCO-VF and 2015 ESMO-MCBS.

Use of Late-Life Expectancy for Assessing the Long-Term Benefit of Immune Checkpoint Inhibitors.

To grade the long-term benefit of anticancer agents, the American Society of Clinical Oncology Value Framework (ASCO-VF) awards tail-of-the-curve bonus points by using milestone survival at twice the median control survival. Here, we propose an alternative, late-life expectancy that we defined as the area under the Kaplan-Meier curve from median control survival to the end of follow-up. We analyzed all indications of immune checkpoint inhibitors with survival data and found that 9 indications out of 13 (69.

Living network meta-analysis was feasible when considering the pace of evidence generation.

Objectives: The aim of the study was to assess the feasibility of living network meta-analysis (NMA) taking into account the pace of evidence generation across different medical areas.

Study Design And Setting: We performed a systematic review to identify published NMAs. For each NMA, we calculated the cumulative number of new trials.

Impact of post-warming culture duration on clinical outcomes of vitrified good-quality blastocyst transfers: a prospective randomized study.

Objective: To determine whether post-warming culture duration (1 hour vs. 18 hours) influences implantation rates (IRs) of good-quality blastocysts (GQB) in a good-prognosis population.

Design: Prospective interventional randomized study.

Impact of Biomarker-based Design Strategies on the Risk of False-Positive Findings in Targeted Therapy Evaluation.

Purpose: When there is more than one potentially predictive biomarker for a new drug, the drug is often evaluated in different subpopulations defined by different biomarkers. We aim to (i) estimate the risk of false-positive findings with this approach and (ii) evaluate the cross-validated adaptive signature design (CVASD) as a potential alternative.

Experimental Design: By using numerically simulated data, we compare the current approach and the CVASD across different settings and scenarios.

Mapping of Crowdsourcing in Health: Systematic Review.

Background: Crowdsourcing involves obtaining ideas, needed services, or content by soliciting Web-based contributions from a crowd. The 4 types of crowdsourced tasks (problem solving, data processing, surveillance or monitoring, and surveying) can be applied in the 3 categories of health (promotion, research, and care).

Objective: This study aimed to map the different applications of crowdsourcing in health to assess the fields of health that are using crowdsourcing and the crowdsourced tasks used.

Rituximab for induction and maintenance therapy of granulomatosis with polyangiitis: a single-centre cohort study on 114 patients.

Objectives: To assess efficacy and safety of rituximab (RTX) induction and maintenance therapy for granulomatosis with polyangiitis (GPA) in a single-centre cohort study.

Methods: All patients with active GPA, not enrolled in trials, who received ⩾1 RTX infusion(s) for induction were included. At remission, protocolized maintenance RTX infusions were given every 6 months for 18 months.

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.

Objectives: To characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency.

Design And Setting: Cross-sectional analysis of postmarketing studies registered in ClinicalTrials.gov until September 2014 for all novel drugs approved by both regulators between 2005 and 2010.

Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.

Should we consider day-2 and day-3 embryo morphology before day-5 transfer when blastocysts reach a similar good quality?

Clinical outcomes of 291 day-5 blastocyst transfers carried out between January 2012 and March 2016 were retrospectively compared according to their quality at day 2 and 3. Inclusion criteria were female age younger than 37 years; first or second IVF and intracytoplasmic sperm injection cycle; quality of the transferred blastocyst: blastocoele B3 or higher; inner-cell-mass A/B; trophectoderm A/B; and known implantation outcome for each transferred blastocyst. Blastocysts were classified into good-quality and poor-quality embryo groups at day 2 and 3.

Evidence for Treatment-by-Biomarker interaction for FDA-approved Oncology Drugs with Required Pharmacogenomic Biomarker Testing.

For oncology drugs that were approved by the US Food and Drug Administration (FDA) and required pharmacogenomic biomarker testing, we describe 1) the use of enrichment (biomarker-positive patients) and a randomized controlled design by pre-approval trials and 2) the treatment-by-biomarker interaction. From the 137 drugs included in the FDA table, we selected the 22 oncology drugs with required genetic testing in their labels. These drugs corresponded to 35 approvals supported by 80 clinical studies included in the FDA medical officer reviews of efficacy.

Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.

Background: Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs.

Materials And Methods: We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015.

Jump, Hop, or Skip: Modeling Practice Effects in Studies of Determinants of Cognitive Change in Older Adults.

Improvements in cognitive test scores upon repeated assessment due to practice effects (PEs) are well documented, but there is no empirical evidence on whether alternative specifications of PEs result in different estimated associations between exposure and rate of cognitive change. If alternative PE specifications produce different estimates of association between an exposure and rate of cognitive change, this would be a challenge for nearly all longitudinal research on determinants of cognitive aging. Using data from 3 cohort studies-the Three-City Study-Dijon (Dijon, France, 1999-2010), the Normative Aging Study (Greater Boston, Massachusetts, 1993-2007), and the Washington Heights-Inwood Community Aging Project (New York, New York, 1999-2012)-for 2 exposures (diabetes and depression) and 3 cognitive outcomes, we compared results from longitudinal models using alternative PE specifications: no PEs; use of an indicator for the first cognitive visit; number of prior testing occasions; and square root of the number of prior testing occasions.

Using an Alzheimer Disease Polygenic Risk Score to Predict Memory Decline in Black and White Americans Over 14 Years of Follow-up.

Evidence on whether genetic predictors of Alzheimer disease (AD) also predict memory decline is inconsistent, and limited data are available for African ancestry populations. For 8253 non-Hispanic white (NHW) and non-Hispanic black (NHB) Health and Retirement Study participants with memory scores measured 1 to 8 times between 1998 and 2012 (average baseline age=62), we calculated weighted polygenic risk scores [AD Genetic Risk Score (AD-GRS)] using the top 22 AD-associated loci, and an alternative score excluding apolipoprotein E (APOE) (AD-GRSexAPOE). We used generalized linear models with AD-GRS-by-age and AD-GRS-by-age interactions (age centered at 70) to predict memory decline.

Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov.

Purpose: The aim of this study was to describe pharmacogenomics-based inclusion criteria (enrichment) and the main characteristics of clinical trials involving oncology-targeted therapies.

Methods: Clinical trials of oncology-targeted therapies approved after 2005 with pharmacogenomic testing required or recommended in their label were retrieved from a mapping of the ClinicalTrials.gov database.

Association of Alzheimer's related genotypes with cognitive decline in multiple domains: results from the Three-City Dijon study.

Several genetic polymorphisms have been associated with Late Onset Alzheimer's Disease (LOAD), but there has been limited evidence on whether these polymorphisms predict intermediary stage outcomes such as cognitive changes in prospective community-based studies. Our aim was to evaluate whether polymorphisms previously established as predictors of LOAD also predict worse cognitive function and accelerated decline across multiple cognitive domains. We analyzed data from the 3C-Dijon study, in which 4931 respondents aged 65+ were examined up to 5 times over 10 years with a neuropsychological assessment.