Open-access clinical trial registries: The Italian scenario

Trials

Volumn 13, Issue , 2012, Pages

  Mosconi, Paola ^a   Roberto, Anna ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

Citizen; Clinical trials registry; Information

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DATA BASE; HUMAN; INFORMATION PROCESSING; ITALY; LANGUAGE; MEDICAL INFORMATION; REGISTER; TEACHING HOSPITAL;

ACCESS TO INFORMATION; CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; DISCLOSURE; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HUMANS; INFORMATION DISSEMINATION; INTERNET; ITALY; REGISTRIES; RESEARCH DESIGN;

EID: 84867570096     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-194     Document Type: Article

References (30)

1. Thornton H. Today's patient: passive or involved?. Lancet 1999, 354(Suppl):SIV48.
2. Godlee F, Chalmers I. Information about ongoing clinical trials for patients. BMJ 2010, 340:c725. 10.1136/bmj.c725, 20181639.
3. Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer 2000, 82:1783-1788. 10.1054/bjoc.2000.1142, 2363224, 10839291.
4. O'Connell D, Mosconi P. An active role for patients in clinical research?. Drug Dev Res 2006, 67:188-192.
5. Stewart RJ, Caird J, Oliver K, Oliver S. Patients' and clinicians' research priorities. Health Expect 2011, 14:439-448. 10.1111/j.1369-7625.2010.00648.x, 21176014.
6. Liberati A. Need to realign patient-oriented and commercial and academic research. Lancet 2011, 378:1777-1778.
7. Lophatananon A, Tyndale-Biscoe S, Malcolm E, Rippon H, Holmes K, Firkins L, Fenton M, Crowe S, Stewart-Brown S, Gnanapragasam V, Muir K. The James Lind Alliance approach to priority setting for prostate cancer research: an integrative methodology based on patient and clinician participation. Br J Urology Int 2011, 108:1040-1043.
8. Staley K. Exploring impact: public involvement in NHS, public health and social care research http://www.invo.org.uk/pdfs/Involve_Exploring_Impactfinal28.10.09.pdf.
9. Mosconi P, Colombo C, Villani W, Liberati A, Satolli R. PartecipaSalute: a research project and a training program tailored on consumers and patients. Healthcare Systems Ergonomics and Patient Safety 2011, 71-76. London: Taylor & Francis Group, Albolino S, Bagnara S, Bellandi T, Llaneza J, Rosal G, Tartaglia R.
10. Hanley B, Truesdale A, King A, Elbourne D, Chalmers I. Involving consumers in designing, conducting, and interpreting randomized controlled trials: questionnaire survey. BMJ 2001, 322:519-523. 10.1136/bmj.322.7285.519, 26555, 11230065.
11. Wyatt K, Carter M, Barnard A, Hawton A, Britten N. The impact of consumer involvement in research: an evaluation of consumer involvement in the London Primary Care Studies Programme. Fam Pract 2008, 25:154-161. 10.1093/fampra/cmn019, 18515813.
12. WMA Declaration of Helsinki Ethical principles for medical research involving human subjects http://www.wma.net/en/30publications/10policies/b3/, WMA Declaration of Helsinki.
13. Roderik F. Viergever. Ghersi D: The quality of registration of clinical trials. PLoS ONE 2011, 6:e14701. 10.1371/journal.pone.0014701, 3044717, 21383991.
14. Willyard C. Pfizer lawsuit spotlights ethics of developing world clinical trials. Nat Med 2007, 13:763. 10.1038/nm0707-763, 17618250.
15. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Ann Intern Med 2004, 141:477-478.
16. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Ann Intern Med 2005, 143:146-148.
17. Pandolfini C, Bonati M. DEC-net: il registro europeo degli studi clinici pediatrici. I primi 200 protocolli inseriti. G Ital Farm Clin 2005, 19:408-410.
18. Watson R. New European online clinical trials register is launched. BMJ 2011, 342:d1994.
19. Public online register gives access to information on clinical trials http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/03/news_detail_001228.jsp&mid=WC0b01ac058004d5c1.
20. Research Activities http://www.marionegri.it/mn/en/sezioni/dipartimenti/labInfo22/attRicerca.html.
21. Pignata S, Scambia G, Savarese A, Breda E, Scollo P, De Vivo R, Rossi E, Gebbia V, Natale D, Del Gaizo F, Naglieri E, Ferro A, Musso P, D'Arco AM, Sorio R, Pisano C, Di Maio M, Signoriello G, Annunziata A, Perrone F. MITO Investigators. safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial. BMC Cancer 2006, 6:202-207. 10.1186/1471-2407-6-202, 1553473, 16882344.
22. Mosconi P, Colombo C, Satolli R, Liberati A. PartecipaSalute, an Italian project to involve lay people, patients' associations and scientific-medical representatives on the health debate. Health Expect 2007, 10:194-204. 10.1111/j.1369-7625.2007.00444.x, 17524012.
23. Moja LP, Moschetti I, Nurbhai M, Compagnoni A, Liberati A, Grimshaw JM, Chan AW, Dickersin K, Krleza-Jeric K, Moher D, Sim I, Volmink J. Compliance of clinical trial registries with the World Health Organization minimum data set: a survey. Trials 2009, 10:56. 10.1186/1745-6215-10-56, 2734552, 19624821.
24. WHO International Clinical Trials Registry Platform (ICTRP) http://www.who.int/ictrp, WHO.
25. Horden A, Georgiou A, Whetton S, Prgomet M. Consumer e-health: an overview of research evidence and implications for future policy. Health Info Manage J 2011, 40:4-5.
26. Dear R, Barratt A, Askie L, McGeechan K, Arora S, Crossing S, Currow S, Tattersall M. Adding value to clinical trial registries: insights from Australian Cancer Trials Online, a website for consumers. Clin Trials 2011, 8:70. 10.1177/1740774510392392, 21335591.
27. Tharyan P, Ghersi D. Registering clinical trials in India: a scientific and ethical imperative. Natl Med J India 2008, 21:31-34.
28. Dreier G, Hasselblatt H, Antes G, Schumacher M. [The German Clinical Trials Register: reasons, general and technical aspects, international integration]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2009, 52:463-468. 10.1007/s00103-009-0833-5, 19308331.
29. Hasselblatt H, Dreier G, Antes G, Schumacher M. The German Clinical Trials Register: challenges and chances of implementing a bilingual registry. J Evid Based Med 2009, 2:36-40. 10.1111/j.1756-5391.2009.01001.x, 21348981.
30. Clinical Trial Register http://registro.marionegri.it/frontend_eng/index.php.