Defining innovations of therapeutic interventions: A position paper by the Italian Society of Hospital Pharmacists

International Journal of Clinical Pharmacy

Volumn 34, Issue 2, 2012, Pages 259-262

  Adami, Silvia ^a   Ciampalini, Susanna ^a   Dell'Aera, Marisa ^a   Di Turi, Roberta ^a   Ferrarese, Annalisa ^a   Messori, Andrea ^a   Palozzo, Angelo ^a   Polidori, Piera ^a   Romero, Marilena ^a   Venturini, Francesca ^a  

^a C/o Area Vasta Centro Toscana ^*  (Italy)

Author keywords

Innovation; Italy; Medical devices; Medicines; SIFO; Study end points; Study evaluation

Indexed keywords

CLINICAL PRACTICE; CLINICAL STUDY; CONSENSUS DEVELOPMENT; CONTROLLED CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG FORMULARY; HUMAN; ITALY; MEDICAL DECISION MAKING; MEDICAL DEVICE; MEDICAL SOCIETY; OUTCOME ASSESSMENT; PHARMACEUTICAL CARE; PHARMACIST; PRACTICE GUIDELINE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; REVIEW;

CLINICAL TRIALS AS TOPIC; DIFFUSION OF INNOVATION; DRUGS, INVESTIGATIONAL; ENDPOINT DETERMINATION; EVIDENCE-BASED MEDICINE; HUMANS; ITALY; PRACTICE GUIDELINES AS TOPIC; RESEARCH DESIGN; SOCIETIES, PHARMACEUTICAL; TERMINOLOGY AS TOPIC; TREATMENT OUTCOME;

EID: 84862879822     PISSN: 22107703     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11096-012-9618-2     Document Type: Review

References (12)

1. van Luijn JC, Gribnau FW, Leufkens HG. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol. 2007;63(2):159-62 (Epub 2006 Dec 7).
2. van Luijn JC, van Loenen AC, Gribnau FW, Leufkens HG. Choice of comparator in active control trials of new drugs. Ann Pharmacother. 2008;42(11):1605-12 (Epub 2008 Oct 28).
3. Motola D, De Ponti F, Poluzzi E, Martini N, Rossi P, Silvani MC, et al. An update on the first decade of the European centralized procedure: how many innovative drugs? Br J Clin Pharmacol. 2006;62(5):610-6.
4. International Society of Drug Bulletins (ISDB). ISDB Declaration on therapeutic advance in the use of medicines. Working group meeting, Paris, France, 15-16 Nov 2001 downloaded from the Revue Prescrire website at URL http://english.prescrire.org/Docu/Archive/docus/ISDBTherapAdvanceEN.pdf.
5. Therapeutic Initiative Working Group (Canada). Assessment process. Available from the Therapeutics Initiative website at URL. http://www.ti.ubc.ca/ workinggroups/drugassessment#asses sprin.
6. Scottish Intercollegiate Guidelines Network (SIGN). SIGN 50- A guideline developer's handbook. Edinburgh, 2008 (revised November 2011). Available from the SIGN website at URL http://www.sign.ac.uk/pdf/sign50.pdf.
7. Anonymous. Chapter 2. Introduction to P-drugs. In: de Vries TPG, Henning RH, Hogerzeil HV, Fresle DA, editors. Guide to good prescribing-a practical manual. Geneva, Switzerland: World Health Organization; 2000.
8. Del Santo F, Maratea D, Messori A. Definizione di farmaco in-novativo: rivisitazione in un contesto di risorse limitate. Phar-macoeconomics, Italian Research Articles; 2011 (in press).
9. Moynihan R. Surrogates under scrutiny: fallible correlations, fatal consequences. BMJ. 2011;343:d5160.
10. Ciani O, Taylor RS. A more evidence based approach to the use of surrogate end points in policy making. BMJ 2011;343. doi: 10.1136/bmj.d6498 (Published 25 October 2011).
11. Kaul S, Diamond GA. Making sense of non-inferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials. Prog Cardiovasc Dis. 2007;49(4):284-99.
12. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD. RE-LY steering committee and investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51.