Documentazione distribuita da A.I.CHE. - Associazione Italiana CHEratoconici ONLUS ( 1. Siena X-linking. Siena 2 Febbraio 2007

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1 1 Siena X-linking Siena 2 Febbraio 2007 Andrea Paolini Comitato Etico per la sperimantazione clinica dei medicinali Azienda Ospedaliera Universitaria Senese c_etico@unisi.it Fondazione Toscana Life Sciences a.paolini@toscanalifesciences.org

Ospedaliera Universitaria Senese 0577 233204 c_etico@unisi.

2 AOUS s Ethics Committee 2 Constitued with deliberation of AOS s GM in concert with the Rector of the Università degli Studi di Siena in September 1999; 18 members with the competences anticipated by the normative in force; 9 ethic committee in Italy for number of appraised clinical trials out of the 304 committees reviewed in 2006 by the Osservatorio Nazionale Sperimentazione Clinica Agenzia Italiana del Farmaco; Competent also regarding clinical trials with medical devices.

committee in Italy for number of appraised clinical trials out of the 304 committees reviewed in 2006 by the

3 Clinical trial and procedures 3 It was chosen to study this new combined treatment technique within a spontaneous clinical study using the support of external technical partners. An informed choice; A necessity

spontaneous clinical study using the support of

4 The original Protocol 4 Title: Medical therapy for Keratoconus using a UVA-riboflavin technique for cross-linking corneal collagen and in vivo investigation using a confocal microscopy for stromal and keratocytes alterations (apoptosis and repopulation) in patients suffering from progressive Keratoconus. Phase: II Promoter: U.O.C. di Oftalmologia (monocentric) Patients: 22

microscopy for stromal and keratocytes alterations (apoptosis and repopulation) in patients

5 Approvals timeframe 5 Monocentric 28 may 2004; Multicentric 28 february 2006; Medical device 8 january Other amendments regarding.

6 the drug 6 Initially supplied by the Swiss company G. Streuli & Co.; As of May 10th 2006 the drug is being supplied by the Italian company Sooft Italia.

7 The actors 7 UOC Oftalmologia Prof. Caporossi Azienda Ospedaliera Universitaria Senese Comitato Etico Medicinali dell AOUS Il Ministero della Salute (Ministry of Health) CSO Sooft Italia (previously Streuli & Co.)

8 Documents for drug trial 8 Economic convention draft; Official acceptance by the Principal Investigator; Principal Investigator s updated Curriculum vitae; Clinical trial design: protocol and synopsis; Investigator's Brochure for the drug (and the package insert, eventually); Patients information and declaration of consent form; Form for the treatment of sensitive data; Dear Doctor letter; Copies of insurance policy or insurance certificate ; Possible list of participating Centres.

drug (and the package insert, eventually); Patients information and declaration of consent form; Form for the treatment

9 Documents for medical device trial 9 Economic convention draft; Official acceptance by the Principal Investigator; Principal Investigator s updated CV; Clinical Protocol: Clinical Evaluation Scheme; Investigator s Brochure; Excerpt from the risks analisys.

Investigator s updated CV; Clinical Protocol: Clinical

10 A risk analysis has to inlcude 10 General requisites; Risk assessment analysis and identification of potential dangers; Risk evaluation and acceptability; Risk control; R/B (risks/benefits) analysis, residual risk; Total residual risk evaluation.

Risk evaluation and acceptability; Risk control; R/B

11 ALARP risk zone 11 (as low as reasonably praticable) Extent of Risk (ER) = Probabily x Severity

12 CE marking 12 Medical devices bearing CE marking, not modified in any part and experimented for the same use as specified in the provisions of the conformity assessment procedures followed for the affixing of such marking; Medical devices not bearing CE marking; Medical devices bearing CE marking but experimented for use other than the one specified in the provisions of the conformity assessment procedures followed for the affixing of such marking.

Medical devices not bearing CE marking; Medical devices bearing CE marking but experimented for use other than

13 Today the protocol differs for 13 Its multicentric nature; The technical modifications made to the equipment; The Company supplying the drug; And mainly, for the experience gained by the Investigators primarily thanks to the cases they ve treated.

Company supplying the drug; And mainly, for the experience

14 Clinical trial s peculiarities 14 Multicentric spontaneous clinical trial; Paternity of the Rational, the study design and the adopted technical solutions; Involves both drug trial and medical device trial; Industrial partners for drug supply and the realization of the medical device only offering technical support.

solutions; Involves both drug trial and medical device trial; Industrial

15 Thanks 15 Prof. Caporossi Dott. Mazzotta, Dott. Baiocchi Sooft Italia, G. Streuli & Co. CSO Lucia Polverelli, Sybilla Hoffer Ministero

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