@ Enpr-EMA annual workshop London. May 28 th 2015 Florence Bosco
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1 @ Enpr-EMA annual workshop London May 28 th 2015 Florence Bosco
2 Have co-founded a non-profit patient recruitment organization in % of the Belgian clinical research activity patients enrolled each year 200 children enrolled each year
3 Precious early adopters from the industry & among the PI s Over 50 pilot cases & abundant learning
4 Involving the medical community III II I 0 Other sites PI s site PI s dept PI + study nurse This comprehensive model we have developed enables us to design specific patient recruitment actions
5 How to chose the right collaboration types Illness/condition prevalence High Type 0, I, II Type 0, I Type 0 Low Type 0, I, II, III Type 0, I, II Type 0 No alternative Significant benefit over alternative Insignificant benefit over alternative Therapeutic options availability The types of action that have the greatest chances to be successful depend very much on patient rationale
6 Fertility clinic, IVF, phase 3, non-inferiority of alternative drug delivery system of an old drug patients in 18 months 10 patients in 3 months 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
7 Emergency department, AHF, phase 3, efficacy of new drug added to standard therapy patiënten h/post 18h/OAP Type I, PI + 2 colleagues in the department, pre-screening every day 2h until end of recruitment, flexible staffing, local software
8 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)
9 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
10 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
11 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
12 «Informed consent logistics» Screening gate IT Tools access: EMR PACS & Lab software Local softwares Collect # & reasons: Key I/E criteria search Refined search Proposals Answers Patient identification Patient information «3 contacts» rule: + Treating physician + Study nurse + PI Create patient contact: Present Visit scheduled soon Far scheduled visit No visit scheduled We make sure pre-screening activities get dedicated study nurse resources, organizational resources & budget
13 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, , ,67 504,00 543,00 427,00 405,00 Subtotal Cost Per Patient 5.233,01 Code Site Costs Qty Budget SC003 Study Start-Up Fee/Site Set-Up Fee ,00 SC008 Pharmacy Set-up fees 1 550,00 SC008 Pharmacy fees ,00 MK103 Site Validation 1 500,00 MK172 Rater Training with Vendor - 20 hr per up to 4 raters - per hour cost ,00 MK172 Rater Refresher and Remedial Training with Vendor - 10 hr per up to 4 raters - per hour cost ,00 MK020 Database Review or Chart / Record Review (Completion Preidentification Verification Form) ,00 MK023 Alzheimer's Screening Program (ASP) ,00 Advertising ,00 SC011 Screen Failures - Full Visit 1 (4:1 ratio) ,72 SC011 Screen Failures - Short Visit ,36 Room for negotiation
14 Thank you for your attention. Your questions and recommendations are welcome.
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