Ruolo infermieristico nei trials clinici

Convegno REPRete Ematologica Pediatrica

Maria Chiara Ariotti

AOU Ospedale S.Luigi Orbassano 23 maggio 2014

Osservatorio nazionaledelle sperimentazioni dei medicinali

Osservatorio nazionaledelle sperimentazioni dei medicinali

Osservatorio nazionaledelle sperimentazioni dei medicinali

Team multiprofessionale

Gli attori della sperimentazione. P.Culotta, L. Callegaro. La ricerca clinica 2008 Ed. medico scientifiche

Autorità regolatoria

soggetto

sponsorricercatore

data manager

Monitor di ricerca clinica

infermiere di

ricerca clinica

Comitato etico indipendente

Steering

committee Data safety and

monitoring committee

Strategia di ricerca

Nomenclatura associataall’infermiere nella ricerca

Studio Shire chelante orale SSP-004184

Attività infermieristiche

nello studio SSP-001484

CENTRE _________________________________________________________

Shire protocol items PHYSICIAN NURSE DATA MANAGER OTHER specify Comments

Screening phaseP1 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’indagineCENTRE _________________________________________________________

Clinical Trials Nursing Questionnaire's items (CTNQ)* Screening phase

Q1

Communicate general information about the nature and goals of clinical research to potential

subject

Q2 Prescreen inquiries ( e.g., thelephone calls) for eligibility requirements

Q3 Screen potential subjects for study participation (e.g., review medical history, pathology)

Q4 Ensure all screening eligibility and enrolment procedures are completed

Q5 Provide the potential subject with additional information to help informed decision-making

Q6

Assess the ability and willingness of subjects to follow and complete study procedures and visits

(e.g., time, cost)

Q7 Implement and evaluate strategies to overcome barriers to protocol compliance

Q8 Assist the subject/family in identifying coping strategies for concerns (e.g., role changes)

Q9 Provide patient teaching about the investigational product (e.g., potential side effects)

Q10 Order/obtain the investigational product

Q11 Verify the proper storage and handling of the investigational product

Chronic phaseQ12 Schedule procedures and tests per protocol requirements

Q13 Perform clinical procedures and tests per protocol requirements(e.g.,phlebotomy)

Q14 Ensure the proper specimens collection

Q15 Ensure the proper specimens processing

Q16 Ensure the proper specimens shipment

Q17 Maintain accountability for the investigational product at the study site

Q18 Verify records are maintained of the investigational product

Q19 Assess subject's compliance with the use of the investigational product

Q20 Assess and document identified toxicities/adverse events per protocol-specific criteria

Q21Assess and document the subject’s concurrent use of either complementary or alternative therapies

Q22 Document any deviation from the approved protocol

Q23 Communicate with the Principal Investigator about the progress of the study

Q24 Ensure the long-term follow-up of subjects

Q25 Resolve data queries

Q26 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.

CENTRE _________________________________________________________

Shire protocol items PHYSICIAN NURSE DATA MANAGER

Screening phaseP1 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

Compilazione strumento d’indagineEs. Orbassano

Compilazione strumento d’indagineCENTRE _________________________________________________________

Clinical Trials Nursing Questionnaire's items (CTNQ)* PHYSICIAN NURSE DATA MANAGER

Screening phase

Q1

Communicate general information about the nature and goals of clinical research to potential

subject

Q2 Prescreen inquiries ( e.g., thelephone calls) for eligibility requirements

Q3 Screen potential subjects for study participation (e.g., review medical history, pathology)

Q4 Ensure all screening eligibility and enrolment procedures are completed

Q5 Provide the potential subject with additional information to help informed decision-making

Q6

Assess the ability and willingness of subjects to follow and complete study procedures and visits

(e.g., time, cost)

Q7 Implement and evaluate strategies to overcome barriers to protocol compliance

Q8 Assist the subject/family in identifying coping strategies for concerns (e.g., role changes)

Q9 Provide patient teaching about the investigational product (e.g., potential side effects)

Q10 Order/obtain the investigational product

Q11 Verify the proper storage and handling of the investigational product

Chronic phaseQ12 Schedule procedures and tests per protocol requirements

Q13 Perform clinical procedures and tests per protocol requirements(e.g.,phlebotomy)

Q14 Ensure the proper specimens collection

Q15 Ensure the proper specimens processing

Q16 Ensure the proper specimens shipment

Q17 Maintain accountability for the investigational product at the study site

Q18 Verify records are maintained of the investigational product

Q19 Assess subject's compliance with the use of the investigational product

Q20 Assess and document identified toxicities/adverse events per protocol-specific criteria

Q21Assess and document the subject’s concurrent use of either complementary or alternative therapies

Q22 Document any deviation from the approved protocol

Q23 Communicate with the Principal Investigator about the progress of the study

Q24 Ensure the long-term follow-up of subjects

Q25 Resolve data queries

Q26 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.

Es. Orbassano

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 / / /

30

18

6

Risultati

Risultati

Risultati

Rapporto tra impegno reale e ideale(medie + intervallo di confidenza 95%)

Eff. corrente: F(2, 12)=8,9989, p=,00410

6 (DM) 18 (Medico) 30 (Infermiere)

Attività ideali per ruolo

-1,0

-0,5

0,0

0,5

1,0

1,5

2,0

2,5

3,0

3,5

4,0

Rap

po

rto

imp

egn

o r

eale

/idea

le

Risultati

Formazione/Riconoscimento

aderenza al trattamento arruolamenti negli studi attendibilità dei dati raccolti comprensione del consenso

diffidenza perdita follow up ansia nei placebo controllati rischio clinico

+

-

Vantaggi per i soggetti arruolati

Nelson A, Nixon J, Mason S. The role and potential contribution of clinical research nurses to

clinical trials. Journal of Clinical Nursing, 2008 17 (4): 549-57

Ocker BM, Plank DMP The research nurse role in a clinic-based oncology research setting

Cancer Nursing, 2008; 23 (4): 286-94

Infermiere e trials clinici

… buon lavoro