@ Enpr-EMA annual workshop London May 28 th 2015 Florence Bosco - - PowerPoint PPT Presentation

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Aug 08, 2023 468 likes •620 views

@ Enpr-EMA annual workshop London May 28 th 2015 Florence Bosco Have co-founded a non-profit patient recruitment organization in 2014 20% of the Belgian clinical research activity 2.000 patients enrolled each year 200 children

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May 28th 2015 Florence Bosco

@ Enpr-EMA annual workshop London

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Have co-founded a non-profit patient recruitment organization in 2014

20% of the Belgian clinical research activity
2.000 patients enrolled each year
200 children enrolled each year

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Precious early adopters from the industry & among the PI’s Over 50 pilot cases & abundant learning

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Involving the medical community

PI + study nurse PI’s dept PI’s site Other sites I II III

This comprehensive model we have developed enables us to design specific patient recruitment actions

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How to chose the right collaboration types

Illness/condition prevalence Therapeutic options availability High Low

Insignificant benefit over alternative Significant benefit over alternative No alternative Type 0, I, II, III Type 0, I, II Type 0, I, II Type 0, I Type 0 Type 0

The types of action that have the greatest chances to be successful depend very much on patient rationale

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Type I, PI + 9 colleagues in the department, half a day weekly pre-screening, for 6 weeks, flexible staffing, local software

284 93 16 7 4 50 100 150 200 250 300 Dossiers Potentielles Propositions Intérêt Randomisées

Fertility clinic, IVF, phase 3, non-inferiority of alternative drug delivery system of an old drug

10 patients in 18 months  10 patients in 3 months

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Emergency department, AHF, phase 3, efficacy

f new drug added to standard therapy

10 20 30 40 50 60 1 2 3 4 5 6 7 8 9 patiënten 24h/post 18h/OAP

Type I, PI + 2 colleagues in the department, pre-screening every day 2h until end of recruitment, flexible staffing, local software

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Pediatric HCV & HBV

Collaboration with obstetrics department
121 mothers with HCV & 173 mothers with HBV
More than 15 obstetricians some of them not

working in the site anymore

Letter signed by the head of department mentioning

the name of the treating obstetrician

Under approval by the EC (in line with internal site

policy)

Type II: One shot retrospective pre-screening since local digital database is in place (10 years)

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Pediatric clostridium difficile

Type II: Permanent automatic pre-screening using alarms from the bacteriology lab

Collaboration with bacteriology lab
Retrospective info: 35 patients in 2014
More than 15 pediatricians
Each time a stools analysis reveals a clostridium

difficile, an alarm is triggered in the lab

The lab informs the study nurse and she contacts the

relevant pediatrician

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Oncology

Type III: Molecular screening agreement

Two studies:

– EGFR mutated cMET amplified NCSLC – TNBC PDL1 +

Country allocation decision
Type III: one site for Belgium + 9 satellite sites

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Our recruitment activation service:

Thanks to both inner and outer activation services we make sure the most pro-active pre-screening actions are put at work

Center activation Network activation Type 0 Always Type I Type II If applicable If applicable Type III If applicable

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« Informed consent logistics »

We make sure pre-screening activities get dedicated study nurse resources, organizational resources & budget

Screening gate Patient identification Patient information « 3 contacts » rule: + Treating physician + Study nurse + PI IT Tools access:

EMR
PACS & Lab software
Local softwares

Create patient contact:

Present
Visit scheduled soon
Far scheduled visit
No visit scheduled

Collect # & reasons:

Key I/E criteria search
Refined search
Proposals
Answers

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Existing budget lines of the CTA

Health Outcome Assessments Maternal and neonatal health care resource use € 4,00 € 4,00 € 4,00 EQ-5D-5L (maternal) € 10,00 € 10,00 € 10,00 Pharmacokinetic Assessments Maternal PK blood sample € 18,00 € 72,00 € 72,00 Cord blood sample € 18,00 € 18,00 Histopathology Placental tissue sample € 18,00 € 18,00 Biomarker Assessments Biomarker and genetic cord blood sample € 18,00 € 18,00 Central laboratory shipping € 14,00 € 14,00 € 14,00 € 14,00 € 14,00 Non-Procedures Study Coordinator € 82,67 € 248,00 € 82,67 € 82,67 € 82,67 € 248,00 € 248,00 € 248,00 € 248,00 Physician € 66,00 € 115,00 € 115,00 € 115,00 € 115,00 € 66,00 € 115,00 € 66,00 € 115,00 Patient travel reimbursement € 22,00 € 22,00 € 22,00 € 22,00 Total Per Visit € 794,67 € 1.374,67 € 1.184,67 € 504,00 € 543,00 € 427,00 € 405,00 Subtotal Cost Per Patient € 5.233,01

Code Site Costs Qty Budget SC003 Study Start-Up Fee/Site Set-Up Fee 1 2.000,00 SC008 Pharmacy Set-up fees 1 550,00 SC008 Pharmacy fees 1 1.595,00 MK103 Site Validation 1 500,00 MK172 Rater Training with Vendor - 20 hr per up to 4 raters - per hour cost 80 7.080,00 MK172 Rater Refresher and Remedial Training with Vendor - 10 hr per up to 4 raters - per hour cost 40 3.540,00 MK020 Database Review or Chart / Record Review (Completion Pre- identification Verification Form) 40 1.888,00 MK023 Alzheimer's Screening Program (ASP) 1 1.500,00 Advertising 1 1.500,00 SC011 Screen Failures - Full Visit 1 (4:1 ratio) 32 53.694,72 SC011 Screen Failures - Short Visit 1 32 11.087,36

 Room for negotiation

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