Publications

Papers under review and invited revisions

Arfè A, Silverman LB, Bourgeois F. Master protocols and adaptive trial designs: essential tools to develop tumor-agnostic drugs for children in the RACE Act era. [Under Review]

Arfè A, Muliere P. A general Bayesian bootstrap for censored data based on the beta-Stacy process. [Under review] ArXiv manuscript

Fell G, Redd R, Vanderbeek A, Rahman R, Arfè A, Alexander B, Ventz S, Trippa L. KMDATA: A database of reconstructed individual patient level data from 153 oncology clinical trials [Under review]

Papers published on refereed journals

Papers marked by [*] appeared in the news media. See In the news for details.

Arfè A, Fell G, Alexander B, Awad M, Rodig S, Trippa L, Schoenfeld J. Pooled analysis of Programmed Death Factor Ligand 1 expression as a predictive biomarker using individual data on 7,918 randomized study patients. JCO Precision Oncology 2020 [Forthcoming].

Arfè A, Peluso S, Muliere P. The semi-Markov beta-Stacy process: a Bayesian non-parametric prior for semi-Markov processes. Statistical Inference for Stochastic Processes 2020 [Forthcoming]. ArXiv manuscript

Arfè A, Alexander B, Trippa L. Optimality of testing procedures for survival data. Biometrics 2020 [Forthcoming]. ArXiv manuscript

Arfè A, Ventz S, Trippa L. Shared and usable data from phase I oncology trials: an unmet need. JAMA Oncology 2020; 6:980-981.

Spring LM*, Fell G*, Arfè A* (*co-primary authors), Sharma C, Greenup R, Reynolds KL, Smith BL, Alexander B,  Moy B, Isakoff SJ, Parmigiani G, Trippa L, Bardia A. Pathological complete response after neoadjuvant chemotherapy and impact on breast cancer recurrence and survival: a comprehensive meta-analysis. Clinical Cancer Research 2020; doi: 10.1158/1078-0432.CCR-19-3492.

Rahman R, Fell G, Ventz S, Arfè A, Vanderbeek A, Trippa L, Alexander B. Deviation from the proportional hazards assumption in randomised phase 3 oncology clinical trials: prevalence, associations, and implications. Clinical Cancer Research 2019; 25:6339-6345.

Arfè A, Quatto P, Morabito G, Zambon A, Manca M, MacIsaac HJ. Long-term ecosystem responses to multiple stressors in a large lake: a Functional Principal Components analysis. Water 2019; 11:962.

Arfè A, Peluso S, Muliere P. Reinforced urns and the subdistribution beta-Stacy process prior for competing risks analysis. Scand J Stat 2018; 46:706-734. ArXiv pre-print.

Masclee GMC, Straatman H, Arfè A, Castellsague J, Garbe E, Herings R, Kollhorst B, Lucchi S, Perez-Gutthann S, Romio S, Schade R, Schink T, Schuemie MJ, Scotti L, Varas-Lorenzo C, Valkhoff VE, Villa M, Sturkenboom MCJM. Risk of acute myocardial infarction during use of individual NSAIDs: A nested case-control study from the SOS project. PLOS ONE. 2018; e0204746.

Schink T, Kollhorst B, Varas-Lorenzo C, Arfè A, Herings R, Lucchi S, Romio S, Schade R,  Schuemie M, Straatman H, Valkhoff V, Villa M, Sturkenboom M, Garbe E. Risk of ischemic stroke and the use of individual non-steroidal anti-inflammatory drugs: A multi-country European database study within the SOS Project. PLOS ONE 2018; e0203362.

Biffi A, Comoretto R, Arfè A, Scotti L, Merlino L, Vaghi A, Pesci A, de Marco R, Corrao G. “CRD Real-World Evidence” scientific board. Can healthcare utilization data reliably capture cases of chronic respiratory diseases? a cross-sectional investigation in Italy. BMC Pulm Med 2017; 17:20.

[*] Arfè A, Scotti L, Varas-Lorenzo C, Nicotra F, Zambon A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Valkhoff V, Romio S, Thiessard F, Schuemie M, Pariente A, Sturkenboom M, Corrao G. On behalf of the Safety of Non-steroidal Anti-inflammatory Drugs (SOS) project consortium. Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study. BMJ 2016; 354:i4857.

Arfè A, Nicotra F, Ghirardi A, Simonetti M, Lapi F, Sturkenboom M, Corrao G; on behalf of the SAFEGUARD project investigators. A probabilistic bias analysis for misclassified categorical exposures, with application to oral anti-hyperglycaemic drugs. Pharmacoepidemiol Drug Saf 2016; 25:1443-1450.

Arfè A, Corrao G. The lag-time approach improved drug-outcome association estimates in presence of protopathic bias. J Clin Epidemiol 2016; 78:101-107.

Arfè A, Blasi F, Merlino L, Corrao G. Respiratory drugs and macrolides prevent asthma exacerbations: A real-world investigation. Respir Med 2016; 119:7-12.

Corrao G, Arfè A, Nicotra F, Ghirardi A, Vaghi A, De Marco R, Pesci A, Merlino L, Zambon A; CRD Real-World Evidence Scientific Board. Persistence with inhaled corticosteroids reduces the risk of exacerbation among adults with asthma: A real-world investigation. Respirology 2016; 21:1034-40.

Arfè A, Nicotra F, Cerveri I, de Marco R, Vaghi A, Merlino L, Corrao G. Incidence, Predictors, and Clinical Implications of Discontinuing Therapy with Inhaled Long-Acting Bronchodilators among Patients with Chronic Obstructive Pulmonary Disease. COPD 2016; 13:540-6.

Arfè A, Corrao G. Tutorial: strategies addressing detection bias were reviewed and implemented for investigating the statins-diabetes association. J Clin Epidemiol 2015; 68:480-8.

Carrara G, Sciré CA, Zambon A, Cimmino MA, Cerra C, Caprioli M, Cagnotto G, Nicotra F, Arfè A, Migliazza S, Corrao G, Minisola G, Montecucco C. A validation study of a new classication algorithm to identify rheumatoid arthritis using administrative health databases: case-control and cohort diagnostic accuracy studies – Results from the RECord linkage On Rheumatic Diseases study of the Italian Society for Rheumatology. BMJ Open 2015;5:e006029

Corrao G, Soranna D, Arfè A, Casula M, Tragni E, Merlino L, Mancia G, Catapano AL. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base. Eur J Intern Med 2014; 25:745-50.

Scotti L, Arfè A, Zambon A, Merlino L, Corrao G. Cost-effectiveness of enhancing adherence with oral bisphosphonates treatment in osteoporotic women: an empirical approach based on healthcare utilisation databases. BMJ Open 2014; 4:e003758

Zambon A, Arfè A, Corrao G, Zanchetti A. Relationships of different types of event to cardiovascular death in trials of antihypertensive treatment: an aid to definition of total cardiovascular disease risk in hypertension. J Hypertens 2014; 32:495-508.

Valkhoff VE, Schade R, ‘t Jong GW, Romio S, Schuemie MJ, Arfè A, Garbe E, Herings R, Lucchi S, Picelli G, Schink T, Straatman H, Villa M, Kuipers EJ, Sturkenboom MC; on behalf of the Safety of Non-steroidal Anti-inflammatory Drugs (SOS) project investigators. Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues? BMC Pediatr 2013; 13:192.

[*] Malvezzi M, Arfè A, Bertuccio P, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2011. Ann Oncol 2011; 22:947-56.

Arfè A, Malvezzi M, Bertuccio P, Decarli A, La Vecchia C, Negri E. Cancer mortality trend analysis in Italy, 1970-2007. Eur J Cancer Prev 2011; 20:364-74.

Blog posts

Plana D, Arfè A, Sinha MS. Envisioning Clinical Trials During The COVID-19 Pandemic. HEALTH AFFAIRS BLOG, 8 June 2020. Link

Regulatory contributions

Plana D, Arfè A, Sinha M. Comments on “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‐19 Pandemic” (FDA‐2020‐D‐1106‐0002). Link

Conference proceedings

Arfè A, Alexander B, Trippa L. Bayesian optimality of testing procedures for survival data. Abstract accepted for an oral presentation at the 30th International Biometric Conference (IBC 2020) [Selected among almost 700 submitted abstracts; Conference cancelled due to COVID-19 pandemic].

Arfè A, Alexander B, Trippa L. Bayesian optimality of testing procedures for survival data. Abstract accepted for an oral presentation at the 2020 World Meeting of the International Society of Bayesian Analysis [Conference postponed to 2021 due to COVID-19 pandemic].

Arfè A, Parmigiani G, Bourgeois F. Leveraging prior data to increase the power of pediatric trial designs. DIA/EFGCP Conference “Better medicines for children”, 16-17 September 2019, Amsterdam, the Netherlands.

Arfè A, Alexander B, Trippa L. Bayesian optimality on testing procedures in the non-proportional hazards setting. Joint Statistical Meetings 2019, July 27-August 1 2019, Denver, Colorado.

Arfè A, Alexander B, Trippa L. Bayesian optimality on testing procedures in the non-proportional hazards setting. Data Science in Biomedical Research – 2019 DFCI/FSTRF Marvin Zelen Memorial Symposium,  5 April 2019, Boston, Massachusetts.

Arfè A, Alexander B, Trippa L. Data-driven late-stage trial designs. International Society for Bayesian Analysis 2018 World Meeting, 24-29 June 2018, Edinburgh, UK.

Arfè A, Peluso S, Muliere P. The subdistribution beta-Stacy process prior for competing risks analysis. 11th conference on Bayesian Nonparametrics, 26-30 June 2017, Paris, France [Poster presentation].

Arfè A, Peluso S, Muliere P. Reinforced urns and the subdistribution beta-Stacy process prior for competing risks analysis. SISbayes 2017 Workshop, Roma 7-8 February 2017 [Invited talk].

Arfè A, Peluso S, Muliere P. Bayesian semiparametric changepoint analysis and short-term forecasting of time series 10th International Workshop on Bayesian Inference in Stochastic Processes (BISP10), 13-15 June 2017, Milan, Italy [Poster presentation].

Arfè A, Quatto P, Zambon A, Morabito G, Manca M. Long-term ecosystem responses to multiple stressors in a large lake: a functional principal components analysis. XXXIII congress of the International Society of Limnology, 31 July-5 August 2016, Turin, Italy [Oral presentation].

Arfè A, Vaghi A, Nicotra F, Romio S, Corrao G. Bayesian misclassication analysis for prevalence estimates derived from healthcare utilization data.  1st International Workshop on Large scale population-based surveys on respiratory health in Italy and Europe, 23-24 October 2014, Verona, Italy [Poster presentation].

Arfè A, Zambon A, Segafredo G, Scotti L, Ghirardi A, Ibrahim B, Soranna D, Nicotra F, Romio S, Corrao G. [Identication of COPD cases in administrative healthcare databases: the CRACK-CRD Project] (In Italian). VII National Conference of the Italian Society of Medical Statistics and Clinical Epidemiology, 25-28 September 2013, Rome, Italy [Oral presentation].

Zambon A, Arfè A, Ghirardi A, Nicotra F, Scotti L, Romio S, Ibrahim B, Soranna D, Corrao G. [Flexible regression models for estimating cumulative drug effects] (in Italian). VII National Conference of the Italian Society of Medical Statistics and Clinical Epidemiology, 25-28 September 2013, Rome, Italy [Oral presentation].

Soranna D, Zambon A, Arfè A, Ghirardi A, Ibrahim B, Nicotra F, Romio S, Scotti L, Corrao G. [Persistence to generic and brand-name antihypertensive drugs] (in Italian). VII National Conference of the Italian Society of Medical Statistics and Clinical Epidemiology, 25-28 September 2013, Rome, Italy [Oral presentation].

Ghirardi A, Segafredo G, Zambon A, Arfè A, Ibrahim B, Nicotra F, Soranna D, Scotti L, Romio S, Corrao G. [Use of antidepressants and risk of fractures] (in Italian). VII National Conference of the Italian Society of Medical Statistics and Clinical Epidemiology, 25-28 September 2013, Rome, Italy [Oral presentation].

Nicotra F, Scognamiglio ET, Soranna D, Scotti L, Zambon A, Romio S, Ghirardi A, Arfè A, Buthaina I, Corrao G. [Meta-analysis of the literature on the association between insuline glargine and cancer risk] (in Italian). VII National Conference of the Italian Society of Medical Statistics and Clinical Epidemiology, 25-28 September 2013, Rome, Italy [Poster presentation].

Zambon A, Arfè A, Corrao G, Zanchetti A. Relationships of Framingham-defined cardiovascular disease events, major cardiovascular events and cardiovasculard death in trials of antihypertensive treatment. 23rd European Meeting on Hypertension and Cardiovascular Protection, 14-17 June 2013, Milan, Italy [Oral presentation].

Arfè A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Nicotra F, Valkhoff VE, Romio S, Thiessard F, Schuemie M, Varas-Lorenzo C, Pariente A, Sturkenboom M, Zambon A. Use of Non-Steroidal Anti-Inflammatory Drugs and Heart Failure Risk in the Safety of Non-Steroidal Anti-Inflammatory Drugs (SOS) Project. 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 23-26 August 2012, Barcellona, Spain [Poster presention].

Kollhorst B, Schink T, Arfè A, Herings R, Romio S, Schade R, Schuemie M, Straatman H, Thiessard F, Valkhoff VE, Varas-Lorenzo C, Villa M, Sturkenboon M, Garbe E. Risk of Ischemic Stroke Associated with the Use of Individual Non-Steroidal Anti-Inflammatory Drugs. 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 23-26 August 2012, Barcellona, Spain [Oral presentation].

Schade R, Neubronner J, Schink T, Valkhoff VE, Romio S, Arfè A, Castellsague J, Corrao G, Herings R, Lucchi S, Picelli G, Straatman H, Thiessard F, Varas-Lorenzo C, Villa M, Garbe E, Sturkenboom M. The CODEX Method: A Systematic Approach for Harmonization of Event Measurement and Data Extraction for Multi-Database Studies: An Application in the SOS Project. 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 23-26 August 2012, Barcellona, Spain [Poster presentation].

Thiessard F, Cossin S, Mougin F, Arfè A, Garbe E, Herings R, Lucchi S, Nicotra F, Picelli G, Romio S, Schade R, Schink T, Straatman H, Valkhoff VE, Haag M, Villa M, Varas-Lorenzo C, Sturkenboom M, Fourrier-Reglat M. Potential Bias When Excluding Concepts from Terminologies with Dierent Granularity: An illustration in the SOS Project. 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 23-26 August 2012, Barcellona, Spain [Poster presentation].

Lucchi S, Valkhoff VE, Kollhorst B, Schink T, Garbe E, Arfè A, Castellsague J, Herings R, Nicotra F, Romio S, Salvo F, Schade R, Schuemie M, Straatman H, Thiessard F, Sturkenboom M, Villa M. Risk of Upper GastroIntestinal Complications Associated with Use of Individual Non-Steroidal Anti-Inflammatory Drugs in the SOS Project. 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 23-26 August 2012, Barcellona, Spain [Poster presentation].

Romio S, Vergouwe Y, Valkhoff VE, Schuemie M, Schade R, Varas-Lorenzo C, Garbe E, Lucchi S, Herings R, Arfè A, Schink S, Neubronner J, Thiessard F, Straatman H, Villa M, Nicotra F, Sturkenboom M, Steyerberg E. Risk Models for Predicting Stroke and Upper Gastrointestinal Complications in NSAID Users: The SOS Project. 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 23-26 August 2012, Barcellona, Spain [Poster presentation].

Arfè A, Scotti L, Ghirardi A, Nicotra F, Soranna D, Zambon A, Corrao G. [The propensity score in bidirectional pharmacoepidemiological study designs] (in Italian). VI National Conference of the Italian Society of Medical Statistics and Clinical Epidemiology, 28 September – 1 October 2011, Ancona, Italy [Poster presentation].

Scotti L, Arfè A, Zambon A, Nicotra F, Ghirardi A, Baio G, Corrao G. [Cost-effectiveness analysis of bisphosphonates use in the primary prevention of osteoporotic fractures] (In Italian). VI National Conference of the Italian Society of Medical Statistics and Clinical Epidemiology, 28 September – 1 October 2011, Ancona, Italy [Poster presentation].

Nicotra F, Arfè A, Scotti L, Zambon A, Garbe E, Herings R, Lucchi L, Picelli G, Romio S, Schade R, Schink T, Straatman H, Thiessard F, Valkhoff V, Villa M, Sturkenboom M, Corrao G. Incidence Rates of Heart Failure in Europe. A Comparison between Different Data Sources in the SOS Project. 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 14-17 August 2011, Chicago, Illinois (USA) [Poster presentation].

Schink T, Arfè A, Herings R, Lucchi L, Picelli G, Romio S, Schade R, Scotti L, Straatman H, Thiessard F, Valkhoff V, Villa M, Sturkenboom M, Garbe E. A Comparison of Incidence Rates of Stroke Estimated from Different Data Sources in the SOS Project. 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 14-17 August 2011, Chicago, Illinois (USA) [Poster presentation].

Lucchi S, Valkhoff V, Arfè A, Garbe E, Herings R, Nicotra F, Picelli G, Romio S, Schade R, Schink T, Straatman H, Thiessard F, Sturkenboom M, Villa M. A Comparison of Incidence Rates of Upper Gastrointestinal Complications Estimated from Different Data Sources in the Safety of NSAIDs (SOS). 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, 14-17 August 2011, Chicago, Illinois (USA) [Poster presentation].