A proposal for a new PhD level curriculum on quantitative methods for drug development.

This paper provides an overview of "Improving Design, Evaluation and Analysis of early drug development Studies" (IDEAS), a European Commission-funded network bringing together leading academic institutions and small- to large-sized pharmaceutical companies to train a cohort of graduate-level medical statisticians. The network is composed of a diverse mix of public and private sector partners spread across Europe, which will host 14 early-stage researchers for 36 months. IDEAS training activities are composed of a well-rounded mixture of specialist methodological components and generic transferable skills. Particular attention is paid to fostering collaborations between researchers and supervisors, which span academia and the private sector. Within this paper, we review existing medical statistics programmes (MSc and PhD) and highlight the training they provide on skills relevant to drug development. Motivated by this review and our experiences with the IDEAS project, we propose a concept for a joint, harmonised European PhD programme to train statisticians in quantitative methods for drug development.

A retrospective study of seven-day consultant working: reductions in mortality and length of stay.

UNLABELLED: Weekend admission is associated with higher in-hospital mortality than weekday admission. Whether providing enhanced weekend staffing for acute medical inpatient services reduces mortality or length of stay is unknown. METHODS: This paper describes a retrospective analysis of in-hospital mortality and length of stay before and after introduction of an enhanced, consultant-led weekend service in acute medicine in November 2012. In-hospital mortality was compared for matching admission calendar months before and after introduction of the new service, adjusted for case volume. Length of stay and 30-day postdischarge mortality were also compared; illness severity of patients admitted was assessed by cross-sectional acuity audits. RESULTS: Admission numbers increased from 6,304 (November 2011-July 2012) to 7,382 (November 2012-July 2013), with no change in acuity score in elderly medical patients but a small fall in younger patients. At the same time, however, a 57% increase in early-warning score triggered calls was seen in 2013 (410 calls vs 262 calls in 2012; p<0.01). Seven-day consultant working was associated with a reduction in in-hospital mortality from 11.4% to 8.8% (p<0.001). Mortality within 30 days of discharge fell from 2.4% to 2.0% (p=0.12). Length of stay fell by 1.9 days (95% CI 1.1-2.7; p=0.004) for elderly medicine wards and by 1.7 days (95% CI 0.8-2.6; p=0.008) for medical wards. Weekend discharges increased from general medical wards (from 13.6% to 18.8%, p<0.001) but did not increase from elderly medicine wards. CONCLUSIONS: Introduction of an enhanced, consultant-led model of working at weekends was associated with reduced in-hospital and 30-day post discharge mortality rates as well as reduced length of stay. These results require confirmation in rigorously designed prospective studies.

Disease-specific survival benefit of lung transplantation in adults: a national cohort study.

The lung transplantation candidate population is heterogeneous and survival benefit has not been established for all patient groups. UK data from a cohort of 1997 adult (aged > or = 16), first lung transplant candidates (listed July 1995 to July 2006, follow-up to December 2007) were analyzed by diagnosis, to assess mortality relative to continued listing. Donor lungs were primarily allocated according to local criteria. Diagnosis groups studied were cystic fibrosis (430), bronchiectasis (123), pulmonary hypertension (74), diffuse parenchymal lung disease (564), chronic obstructive pulmonary disease (COPD, 647) and other (159). The proportion of patients in each group who died while listed varied significantly (respectively 37%, 48%, 41%, 49%, 19%, 38%). All groups had an increased risk of death at transplant, which fell below waiting list risk of death within 4.3 months. Thereafter, the hazard ratio for death relative to listing ranged from 0.34 for cystic fibrosis to 0.64 for COPD (p < 0.05 all groups except pulmonary hypertension). Mortality reduction was greater after bilateral lung transplantation in pulmonary fibrosis patients (p = 0.049), but not in COPD patients. Transplantation appeared to improve survival for all groups. Differential waiting list and posttransplant mortality by diagnosis suggest further use and development of algorithms to inform lung allocation.