Ruolo infermieristico nei trials clinici

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1 Convegno REP Rete Ematologica Pediatrica Ruolo infermieristico nei trials clinici AOU Ospedale S.Luigi Orbassano 23 maggio 2014 Maria Chiara Ariotti

2 Osservatorio nazionale delle sperimentazioni dei medicinali

3 Osservatorio nazionale delle sperimentazioni dei medicinali

4 Osservatorio nazionale delle sperimentazioni dei medicinali

5 Team multiprofessionale Autorità regolatoria Comitato etico indipendente infermiere di ricerca clinica soggetto ricercatore sponsor data manager Steering committee Monitor di ricerca clinica Data safety and monitoring committee Gli attori della sperimentazione. P.Culotta, L. Callegaro. La ricerca clinica 2008 Ed. medico scientifiche

6 Strategia di ricerca

7 Nomenclatura associata all infermiere nella ricerca

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9 Studio Shire chelante orale SSP

10 Attività infermieristiche nello studio SSP

11 CENTRE CENTRE Shire protocol items PHYSICIAN NURSE DATA MANAGER Clinical OTHER Trials Nursing specify Questionnaire's Comments items (CTNQ)* Screening phase P1 Verify Patient Eligibility P2 Update Medical History P3 Informed Consent collection P4 Inclusion/Exclusion criteria collection P5 Review Medical History P6 Complete PE P7 Test for visual acuity P8 Eye examination with an ophthalmoscope P9 12-lead ECG P10 Vital Signs (HR, BP, RR, T, W) P11 Height sitting and standing P12 Concomitant Medications P13 Blood sampling P14 UA with Microscopy P15 Urine Pregnancy Test P16 MRI (FerriScan, T2*, R2* and LVEF) scheduling P17 Audiometry P18 Enroll using IWR system Chronic phase P19 Drug Dosing P20 PK blood sampling P21 PK urine sampling P22 Limited PE P23 Collect Adverse Events P24 Collect returned investigational drug P25 Count pills P26 Calculate Dosing Period P27 Dispense drug bottles P28 Restart previous chelating therapy Strumento d indagine Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q22 Q23 Q24 Q25 Q26 Screening phase Communicate general information about the nature and goals of clinical research to potential subject Prescreen inquiries ( e.g., thelephone calls) for eligibility requirements Screen potential subjects for study participation (e.g., review medical history, pathology) Ensure all screening eligibility and enrolment procedures are completed Provide the potential subject with additional information to help informed decision-making Assess the ability and willingness of subjects to follow and complete study procedures and visits (e.g., time, cost) Implement and evaluate strategies to overcome barriers to protocol compliance Assist the subject/family in identifying coping strategies for concerns (e.g., role changes) Provide patient teaching about the investigational product (e.g., potential side effects) Order/obtain the investigational product Verify the proper storage and handling of the investigational product Chronic phase Schedule procedures and tests per protocol requirements Perform clinical procedures and tests per protocol requirements(e.g.,phlebotomy) Ensure the proper specimens collection Ensure the proper specimens processing Ensure the proper specimens shipment Maintain accountability for the investigational product at the study site Verify records are maintained of the investigational product Assess subject's compliance with the use of the investigational product Assess and document identified toxicities/adverse events per protocol-specific criteria Assess and document the subject s concurrent use of either complementary or alternative therapies Document any deviation from the approved protocol Communicate with the Principal Investigator about the progress of the study Ensure the long-term follow-up of subjects Resolve data queries Prepare for regulatory inspections of records and documents *Heidi E. Ehrenberger, Linda Lillington.Development of a measure to delineate the clinical trials nursing role." In: Oncology nursing forum 31.3 (may. 2004), E64-8.

12 Compilazione strumento d indagine CENTRE Es. Orbassano Shire protocol items PHYSICIAN NURSE DATA MANAGER Screening phase P1 Verify Patient Eligibility P2 Update Medical History P3 Informed Consent collection P4 Inclusion/Exclusion criteria collection P5 Review Medical History P6 Complete PE P7 Test for visual acuity P8 Eye examination with an ophthalmoscope P9 12-lead ECG P10 Vital Signs (HR, BP, RR, T, W) P11 Height sitting and standing P12 Concomitant Medications P13 Blood sampling P14 UA with Microscopy P15 Urine Pregnancy Test P16 MRI (FerriScan, T2*, R2* and LVEF) scheduling P17 Audiometry P18 Enroll using IWR system Chronic phase P19 Drug Dosing P20 PK blood sampling P21 PK urine sampling P22 Limited PE P23 Collect Adverse Events P24 Collect returned investigational drug P25 Count pills P26 Calculate Dosing Period P27 Dispense drug bottles P28 Restart previous chelating therapy

13 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q22 Q23 Q24 Q25 Q26 Compilazione strumento d indagine CENTRE Es. Orbassano Clinical Trials Nursing Questionnaire's items (CTNQ)* PHYSICIAN NURSE DATA MANAGER Screening phase Communicate general information about the nature and goals of clinical research to potential subject Prescreen inquiries ( e.g., thelephone calls) for eligibility requirements Screen potential subjects for study participation (e.g., review medical history, pathology) Ensure all screening eligibility and enrolment procedures are completed Provide the potential subject with additional information to help informed decision-making Assess the ability and willingness of subjects to follow and complete study procedures and visits (e.g., time, cost) Implement and evaluate strategies to overcome barriers to protocol compliance Assist the subject/family in identifying coping strategies for concerns (e.g., role changes) Provide patient teaching about the investigational product (e.g., potential side effects) Order/obtain the investigational product Verify the proper storage and handling of the investigational product Chronic phase Schedule procedures and tests per protocol requirements Perform clinical procedures and tests per protocol requirements(e.g.,phlebotomy) Ensure the proper specimens collection Ensure the proper specimens processing Ensure the proper specimens shipment Maintain accountability for the investigational product at the study site Verify records are maintained of the investigational product Assess subject's compliance with the use of the investigational product Assess and document identified toxicities/adverse events per protocol-specific criteria Assess and document the subject s concurrent use of either complementary or alternative therapies Document any deviation from the approved protocol Communicate with the Principal Investigator about the progress of the study Ensure the long-term follow-up of subjects Resolve data queries Prepare for regulatory inspections of records and documents *Heidi E. Ehrenberger, Linda Lillington.Development of a measure to delineate the clinical trials nursing role." In: Oncology nursing forum 31.3 (may. 2004), E64-8.

14 Risultati Attività ideali Figure coinvolte negli studi N- Attività reali Impegno % Impegno rispetto all'ideale % Infermiere-Orbassano 14 26% 47% Infermiere-Cagliari 8 15% 27% Infermiere-Smirne 4 7% 13% Infermiere-Genova 9 17% 30% Infermiere-Milano 6 11% 20% Medico-Orbassano 42 78% 233% Medico-Cagliari 45 83% 250% Medico-Smirne 32 59% 178% Medico-Genova 36 67% 200% Medico-Milano 42 78% 233% Data manager-orbassano 13 24% 217% Data manager-cagliari 22 41% 367% Data manager-smirne 16 30% 267% Data manager-genova 22 41% 367% Data manager-milano / / /

15 Risultati

16 Risultati 4,0 Rapporto tra impegno reale e ideale (medie + intervallo di confidenza 95%) Eff. corrente: F(2, 12)=8,9989, p=, ,5 Rapporto impegno reale/ideale 3,0 2,5 2,0 1,5 1,0 0,5 0,0-0,5-1,0 6 (DM) 18 (Medico) 30 (Infermiere) Attività ideali per ruolo

17 Risultati

18 Formazione/Riconoscimento

19 Vantaggi per i soggetti arruolati aderenza al trattamento arruolamenti negli studi attendibilità dei dati raccolti comprensione del consenso diffidenza perdita follow up ansia nei placebo controllati rischio clinico + - Nelson A, Nixon J, Mason S. The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing, (4): Ocker BM, Plank DMP The research nurse role in a clinic-based oncology research setting Cancer Nursing, 2008; 23 (4):

20 Infermiere e trials clinici buon lavoro