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

@ 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 enrolled each year

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

Involving the medical community Other sites III PI’s site II PI’s dept I PI + study nurse 0 This comprehensive model we have developed enables us to design specific patient recruitment actions

How to chose the right collaboration types Illness/condition prevalence High Type 0, I, II Type 0, I Type 0 Type Low Type 0, I, II Type 0 0, I, II, III Therapeutic options Significant Insignificant No availability benefit over benefit over alternative alternative alternative The types of action that have the greatest chances to be successful depend very much on patient rationale

Fertility clinic, IVF, phase 3, non-inferiority of alternative drug delivery system of an old drug 300 284 250 10 patients in 18 months 200  10 patients in 3 months 150 93 100 50 16 7 4 0 Dossiers Potentielles Propositions Intérêt Randomisées Type I, PI + 9 colleagues in the department, half a day weekly pre-screening, for 6 weeks, flexible staffing, local software

Emergency department, AHF, phase 3, efficacy of new drug added to standard therapy 60 50 40 patiënten 30 20 10 0 1 2 3 4 5 6 7 8 9 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

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)

Pediatric clostridium difficile • 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 Type II: Permanent automatic pre-screening using alarms from the bacteriology lab

Oncology • Two studies: – EGFR mutated cMET amplified NCSLC – TNBC PDL1 + • Country allocation decision • Type III: one site for Belgium + 9 satellite sites Type III: Molecular screening agreement

Our recruitment activation service: Center activation Network activation Type 0 Always Type III If applicable Type I If applicable Type II If applicable Thanks to both inner and outer activation services we make sure the most pro-active pre-screening actions are put at work

« Informed consent logistics » Screening gate « 3 contacts » rule: IT Tools access: + Treating physician EMR • + Study nurse • PACS & Lab software identification information + PI • Local softwares Patient Patient Create patient contact: Collect # & reasons: Present • • Key I/E criteria search • Visit scheduled soon • Refined search • Far scheduled visit • Proposals • No visit scheduled • Answers We make sure pre-screening activities get dedicated study nurse resources, organizational resources & budget

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 Rater Training with Vendor - 20 hr per up to 4 raters - per hour MK172 80 7.080,00 cost Rater Refresher and Remedial Training with Vendor - 10 hr per up MK172 40 3.540,00 to 4 raters - per hour cost Database Review or Chart / Record Review (Completion Pre- MK020 40 1.888,00 identification Verification Form) 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

Thank you for your attention. Your questions and recommendations are welcome.