Il team di CORESEARCH è in possesso di una esperienza assai significativa nel disegno, nella conduzione e nell’analisi di sperimentazioni cliniche controllate.
Le sperimentazioni condotte ad esempio in diabetologia, nefrologia, cardiologia e oncologia hanno riguardato oltre 15.000 soggetti con il coinvolgimento di ben 700 centri.

Le attività si articolano in:

  • Sviluppo del protocollo dello studio
  • Sviluppo del piano di analisi statistica
  • Sviluppo di CRF elettroniche e web-based
  • Rapporti con i centri e gestione del flusso dei dati
  • Analisi statistica
  • Creazione dello statistical study report
  • Creazione del clinical study report
  • Redazione di testi per l’edizione di abstracts e articoli scientifici


Contract Research Organization (CRO)

CORESEARCH è registrata presso l’Agenzia Italiana del Farmaco (AIFA) in qualità di Organizzazione di Ricerca a Contratto (CRO) per lo svolgimento delle attività di monitoraggio degli studi nel rispetto delle GCP, inclusi i rapporti con i comitati etici per l’iter di approvazione dello studio, e per attività di statistica e gestione dei dati (DM 15/11/2011).
CORESEARCH svolge attività di monitoraggio anche in altri Paesi europei.

 

Pubblicazioni:

  1. Musacchio N, Ciullo I, Scardapane M, Giancaterini A, Pessina L, Maino S, Gaiofatto R, Nicolucci A, Rossi MC; Self-Care Study Group. Efficacy of self-monitoring blood glucose as a key component of a chronic care model versus usual care in type 2 diabetes patients treated with oral agents: results of a randomized trial. Acta Diabetol 2018; 55: 295-299
  2. Vaccaro O, Masulli M, Nicolucci A, Bonora E, Del Prato S, Maggioni AP, Rivellese AA, Squatrito S, Giorda CB, Sesti G, Mocarelli P, Lucisano G, Sacco M, Signorini S, Cappellini F, Perriello G, Babini AC, Lapolla A, Gregori G, Giordano C, Corsi L, Buzzetti R, Clemente G, Di Cianni G, Iannarelli R, Cordera R, La Macchia O, Zamboni C, Scaranna C, Boemi M, Iovine C, Lauro D, Leotta S, Dall’Aglio E, Cannarsa E, Tonutti L, Pugliese G, Bossi AC, Anichini R, Dotta F, Di Benedetto A, Citro G, Antenucci D, Ricci L, Giorgino F, Santini C, Gnasso A, De Cosmo S, Zavaroni D, Vedovato M, Consoli A, Calabrese M, di Bartolo P, Fornengo P, Riccardi G; Thiazolidinediones Or Sulfonylureas Cardiovascular Accidents Intervention Trial (TOSCA.IT) study group; under the mandate of the Italian Diabetes Society. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial. Lancet Diabetes Endocrinol 2017; 5: 887-897.
  3. Balducci S, D’Errico V, Haxhi J, Sacchetti M, Orlando G, Cardelli P, Vitale M, Bollanti L, Conti F, Zanuso S, Nicolucci A, Pugliese G Italian Diabetes and Exercise Study 2 (IDES­_2) Investigators. Effect of a Behavioral Intervention Strategy for Adoption and Maintenance of a Physically Active Lifestyle: The Italian Diabetes and Exercise Study 2 (IDES_2): A Randomized Controlled Trial. Diabetes Care 2017; 40: 1444-1452.
  4. Saglimbene V, Natale P, Palmer S, Scardapane M, Craig JC, Ruospo M, Gargano L, Lucisano G, Török M, Celia E, Gelfman R, Bednarek-Skublewska A, Dulawa J, Stroumza P, Leal M, Del Castillo D, Murgo AM, Schon S, Wollheim C, Hegbrant J, Strippoli GFM. The prevalence and correlates of low sexual functioning in women on hemodialysis: A multinational, cross-sectional stud PLoS One 2017; 12: e0179511.
  5. Balducci S, D’Errico V, Haxhi J, Sacchetti M, Orlando G, Cardelli P, Di Biase N, Bollanti L, Conti F, Zanuso S, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. Level and correlates of physical activity and sedentary behavior in patients with type 2 diabetes: A cross-sectional analysis of the Italian Diabetes and Exercise Study_2. PLoS One. 2017 Mar 14;12(3):e0173337. doi: 10.1371/journal.pone.0173337. eCollection 2017.
  6. Cosmi F, Latini R, Nicolucci A. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med 2017; 376: 890.
  7. Saglimbene V, Palmer SC, Craig JC, Ruospo M, Nicolucci A, Tonelli M, Johnson D, Lucisano G, Williams G, Valentini M, D’Alonzo D, Pellegrini F, Strippoli P, Salomone M, Santoro A, Maffei S, Hegbrant J, Tognoni G, Strippoli GF; CE-DOSE Study Investigators. Low versus high dose erythropoiesis-stimulating agents in hemodialysis patients with anemia: A randomized clinical trial. PLoS One. 2017 Mar 1;12(3):e0172735. doi: 10.1371/journal.pone.0172735. eCollection 2017.
  8. Di Bartolo P, Nicolucci A, Cherubini V, Iafusco D, Scardapane M, Rossi MC. Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the i-NewTrend randomized clinical trial. Acta Diabetol 2017; 54: 393-402.
  9. Vitale M, Masulli M, Rivellese AA, Bonora E, Cappellini F, Nicolucci A, Squatrito S, Antenucci D, Barrea A, Bianchi C, Bianchini F, Fontana L, Fornengo P, Giorgino F, Gnasso A, Mannucci E, Mazzotti A, Nappo R, Palena AP, Pata P, Perriello G, Potenziani S, Radin R, Ricci L, Romeo F, Santini C, Scarponi M, Serra R, Timi A, Turco AA, Vedovato M, Zavaroni D, Grioni S, Riccardi G, Vaccaro  O; TOSCA.IT Study Group.. Dietary intake and major food sources of polyphenols in people with type 2 diabetes: The TOSCA.IT Study. Eur J Nutr. 2016 Dec 21.
  10. Vitale M, Vaccaro O, Masulli M, Bonora E, Del Prato S, Giorda CB, Nicolucci A, Squatrito S, Auciello S, Babini AC, Bani L, Buzzetti R, Cannarsa E, Cignarelli M, Cigolini M, Clemente G, Cocozza S, Corsi L, D’Angelo F, Dall’Aglio E, Di Cianni G, Fontana L, Gregori G, Grioni S, Giordano C, Iannarelli R, Iovine C, Lapolla A, Lauro D, Laviola L, Mazzucchelli C, Signorini S, Tonutti L, Trevisan R, Zamboni C, Riccardi G, Rivellese AA; TOSCA.IT Study Group.. Polyphenol intake and cardiovascular risk factors in a population with type 2 diabetes: The TOSCA.IT study. Clin Nutr. 2016 Nov 14. pii: S0261-5614(16)31316-4.
  11. Cherubini V, Pintaudi B, Iannilli A, Pambianchi M, Ferrito L, Nicolucci A. Long-acting Insulin Analogs Effect on gh/igf Axis of Children with Type 1 Diabetes: a Randomized, Open-label, Two-period, Cross-over Trial. Exp Clin Endocrinol Diabetes. 2016 May;124(5):276-82
  12. Balducci S, Sacchetti M, Haxhi J, Orlando G, Zanuso S, Cardelli P, Cavallo S, D’Errico V, Ribaudo MC, Di Biase N, Salvi L, Vitale M, Bollanti L, Conti FG, Nicolucci A, Pugliese G; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators. The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle. Trials. 2015;16:569.
  13. Nicolucci A, Cercone S, Chiriatti A, Muscas F, Gensini G. A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes. Diabetes Technol Ther. 2015;17:563-70.
  14. Valentini M, Scardapane M, Bondanini F, Bossi A, Colatrella A, Girelli A, Ciucci A, Leotta S, Minotti E, Pasotti F, Pesenti A, Rocca L, Sciangula L, Vavassori E, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 33G × 4 mm. AGO 01 study. Curr Med Res Opin. 2015;31:487-92.
  15. Rossi MC, Nicolucci A, Lucisano G, Pellegrini F, Di Bartolo P, Miselli V, Anichini R, Vespasiani G; DID Study Group. Impact of the “Diabetes Interactive Diary” telemedicine system on metabolic control, risk of hypoglycemia, and quality of life: a randomized clinical trial in type 1 diabetes. Diabetes Technol Ther. 2013;15:670-9.
  16. Saglimbene V, D’Alonzo D, Ruospo M, Vecchio M, Natale P, Gargano L, Nicolucci A, et al. Effects of Dose of Erythropoiesis Stimulating Agents on Cardiovascular Outcomes, Quality of Life and Costs of Haemodialysis. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) Trial]. G Ital Nefrol. 2013 Mar-Apr;30(2).
  17. Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, Abraham M, Medeiros Alencar VH, Badran A, Bonfill X, Bradbury J, Clarke M, Collins R, Davis SR, Delmestri A, Forbes JF, Haddad P, Hou MF, Inbar M, Khaled H, Kielanowska J, Kwan WH, Mathew BS, Mittra I, Müller B, Nicolucci A, Peralta O, Pernas F, Petruzelka L, Pienkowski T, Radhika R, Rajan B, Rubach MT, Tort S, Urrútia G, Valentini M, Wang Y, Peto R; Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805-16.
  18. Genovese S, De Berardis G, Nicolucci A, Mannucci E, Evangelista V, Totani L, Pellegrini F, Ceriello A. Effect of Pioglitazone Versus Metformin on Cardiovascular Risk Markers in Type 2 Diabetes. Adv Ther. 2013 Feb;30(2):190-202.
  19. Balducci S, Zanuso S, Cardelli P, Salvi L, Bazuro A, Pugliese L, Maccora C, Iacobini C, Conti FG, Nicolucci A, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of high- versus low-intensity supervised aerobic and resistance training on modifiable cardiovascular risk factors in type 2 diabetes; the Italian Diabetes and Exercise Study (IDES). PLoS One. 2012;7(11):e49297.
  20. Vaccaro O, Masulli M, Bonora E, Del Prato S, Nicolucci A, Rivellese AA, Riccardi G; TOSCA.IT Study Group. The TOSCA.IT trial: a study designed to evaluate the effect of pioglitazone versus sulfonylureas on cardiovascular disease in type 2 diabetes. Diabetes Care. 2012;35:e82.
  21. Vaccaro O, Masulli M, Bonora E, Del Prato S, Giorda CB, Maggioni AP, Mocarelli P, Nicolucci A, Rivellese AA, Squatrito S, Riccardi G; TOSCA.IT study group (Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents. Intervention Trial). Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2012;22:997-1006.
  22. Nicolucci A, Balducci S, Cardelli P, Cavallo S, Fallucca S, Bazuro A, Simonelli P, Iacobini C, Zanuso S, Pugliese G; Italian Diabetes Exercise Study Investigators. Relationship of exercise volume to improvements of quality of life with supervised exercise training in patients with type 2 diabetes in a randomised controlled trial: the Italian Diabetes and Exercise Study (IDES). Diabetologia. 2012;55:579-88.
  23. Balducci S, Zanuso S, Cardelli P, Salvi L, Mazzitelli G, Bazuro A, Iacobini C, Nicolucci A, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Changes in physical fitness predict improvements in modifiable cardiovascular risk factors independently of body weight loss in subjects with type 2 diabetes participating in the Italian Diabetes and Exercise Study (IDES). Diabetes Care. 2012;35:1347-54.
  24. Del Prato S, Nicolucci A, Lovagnini-Scher AC, Turco S, Leotta S, Vespasiani G; ELEONOR Study Group. Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study. Diabetes Technol Ther. 2012;14:175-82.
  25. Nicolucci A, Del Prato S, Vespasiani G; ELEONOR Study Group. Optimizing insulin glargine plus one injection of insulin glulisine in type 2 diabetes in the ELEONOR study: similar effects of telecare and conventional self-monitoring of blood glucose on patient functional health status and treatment satisfaction. Diabetes Care. 2011;34:2524-6.
  26. Franciosi M, Lucisano G, Pellegrini F, Cantarello A, Consoli A, Cucco L, Ghidelli R, Sartore G, Sciangula L, Nicolucci A; ROSES Study Group. ROSES: role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial. Diabet Med. 2011;28:789-96.
  27. Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES). Arch Intern Med. 2010;170:1794-803.
  28. Rossi MC, Nicolucci A, Di Bartolo P, Bruttomesso D, Girelli A, Ampudia FJ, Kerr D, Ceriello A, Mayor Cde L, Pellegrini F, Horwitz D, Vespasiani G. Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study. Diabetes Care. 2010;33:109-15.
  29. Hackshaw A, Baum M, Fornander T, Nordenskjold B, Nicolucci A, Monson K, Forsyth S, Reczko K, Johansson U, Fohlin H, Valentini M, Sainsbury R. Long-term effectiveness of adjuvant goserelin in premenopausal women with early breast cancer. J Natl Cancer Inst. 2009;101:341-9.
  30. Nicolucci A. Aspirin for primary prevention of cardiovascular events in diabetes: still an open question. JAMA. 2008;300:2180-1.
  31. Maione A, Nicolucci A, Craig JC, Tognoni G, Moschetta A, Palasciano G, Pugliese G, Procaccini DA, Gesualdo L, Pellegrini F, Strippoli GF; LIRICO study group. Protocol of the Long-term Impact of RAS Inhibition on Cardiorenal Outcomes (LIRICO) randomized trial. J Nephrol. 2007;20:646-55.
  32. Strippoli GF, Tognoni G, Navaneethan SD, Nicolucci A, Craig JC. Haemoglobin targets: we were wrong, time to move on. Lancet. 2007;369:346-50.
  33. De Berardis G, Sacco M, Evangelista V, Filippi A, Giorda CB, Tognoni G, Valentini U, Nicolucci A; ACCEPT-D Study Group. Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes (ACCEPT-D): design of a randomized study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins. Trials. 2007;8:21.
  34. Baum M, Hackshaw A, Houghton J, Rutqvist L, Fornander T, Nordenskjold B, Nicolucci A, Sainsbury R; ZIPP International Collaborators’ Group. Adjuvant goserelin in pre-menopausal patients with early breast cancer: Results from the ZIPP study. Eur J Cancer. 2006;42:895-904.
  35. Belfiglio M, Valentini M, Pellegrini F, De Berardis G, Franciosi M, Rossi MC, Sacco M, Nicolucci A; Interdisciplinary Group for Cancer Care Evaluated (GIVIO) Group. Twelve-year mortality results of a randomized trial of 2 versus 5 years of adjuvant tamoxifen for postmenopausal early-stage breast carcinoma patients (SITAM 01). Cancer. 2005;104:2334-9.
  36. Sacco M, Valentini M, Belfiglio M, Pellegrini F, De Berardis G, Franciosi M, Nicolucci A. Randomized trial of 2 versus 5 years of adjuvant tamoxifen for women aged 50 years or older with early breast cancer: Italian interdisciplinary group for Cancer Evaluation Study of Adjuvant Treatment in Breast Cancer 01. J Clin Oncol. 2003; 21:2276-2281
  37. Sacco M, Pellegrini F, Roncaglioni MC, Avanzini F, Tognoni G, Nicolucci A, on behalf of the PPP Collaborative Group. Primary Prevention of Cardiovascular Events with Low-Dose Aspirin and Vitamin E in Type 2 Diabetic Patients. Results of the Primary Prevention Project (PPP) trial. Diabetes Care 2003; 26:3264-3272.
  38. The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists’ Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal woman with early breast cancer: first results of the ATAC randomised trial. Lancet 2002; 359:2131-39.
  39. Scorpiglione N, Belfiglio M, Carinci F, Cavaliere D, De Curtis A, Franciosi M, Mari E, Sacco M, Tognoni G, Nicolucci A. The effectiveness, safety and epidemiology of the use of acarbose in the treatment of patients with type 2 diabetes mellitus. A model of medicine-based evidence. European Journal of Clinical Pharmacology 1999; 55: 239-49.