Achievement of a large NIS by leveraging on Viedoc’s ... · Ipsen is a global biopharmaceutical group dedicated to improving lives through innovative medicines in : Oncology Neuroscience

Achievement of a large NIS by leveraging on Viedoc’s design capabilities

- IPSEN Biometry -Viedoc User Group meeting, ParisNovember, 28th, 2019

Agenda

2

01 Context

02 Viedoc design

03 Challenges duringstudy conduct

04 Outcome

Context

Ipsen / Medical Affairs

3

01

4

Introducing IPSEN01

Ipsen is a global biopharmaceutical group dedicated to improving lives through innovative medicines in :

Oncology Neuroscience Rare Diseases.

We also have a well-established and successful Consumer Healthcare business.

We are committed to discovering new solutions for targeting debilitating diseases and improving the quality of life for patients.

5

Introducing IPSEN01

2018 sales in € : 2.2 Billions 5,700 employees

6

Medical Affairs Biometry01

What we do : Oversight of DM/Stat activities on Medical Affairs studies : Mostly Non-Interventional studies

Registries, PASS, scale validation, Health economics studies…but also …

Interventional studies Global or affiliates studies +50 studies currently running

7

IPSEN and Viedoc01

Viedoc early adopters : First study in 2006 in Ipsen Nordics

40 projects so far Ipsen doesn’t perform the eCRF design

Viedoc set-up outsourced to the CRO in charge of Biometrics

Viedoc Design

ULIS III : a case study

Subject - Internal Ipsen/ External Ipsen/ Confidential Ipsen/ Highly confidential Ipsen (delete unnecessary mentions)8

02

9

02

Part of the ULIS programme “Upper Limb Spasticity” ULIS I started in 2007

Non-interventional study 1004 subjects (followed up for 2 years) in 14 countries Complex design

Forms beings triggered by complex visibility conditions 51 unique forms 1291 forms in total

Primary end point : Goal Attainment Scale (GAS)

10

GOAL SETTING

Goal Area

Goal Sub-category

SMART Goal Statement(Including goal parameter)

Goal Parameters

Standardised Measures

Baseline Standardised Measure Score (SMS)

BASELINE Goal Parameter Score (GPS)

TARGETED Goal Parameter Score (GPS)

Time to achieve the Goal

BASELINE Goal RatingSome function / No function

Visit N (baseline)

GAS (Goal Attainment Scale)01

11

GOAL STATEMENT

Achieved SMSAchieved GPS

ACHIEVED GOAL RatingGot worse / No change / Partially achieved / As

expected / A little more / A lot more

Standardised Measures

Baseline Standardised Measure Score (SMS)

Visit N+1

Visit N

SMART Goal Statement

Time to achieve the Goal

BASELINE Goal Rating-1 / -2

BASELINE Goal Parameter Score (GPS)TARGETED Goal Parameter Score (GPS)

01 GAS (Goal Attainment Scale)

12

Goal Parameters and Standardized Measures02

Except Pain : SM is identical to GP.

One GP One SMOne Goal

Once goal is entered, eCRF guides the user by triggerringthe appropriate forms.

13

ULIS 302 2014 : Launch of Viedoc 4

Viedoc 3 Viedoc 4

14

ULIS 302

ULIS III : go V3 or V4 ? Limitations in V3

Reported fields were editable Old interface (painful navigation across sites/countries…)

V4 : Very limited experience (only one small NIS just initiated) some functions, documentations (training…) were missing Risky approach to go V4 with such a big study as it was a brand new product

we hardly knew.

=> Summer 2014 : DECISION TO GO Viedoc 4 on ULIS 3.

15

Set-up timelines02

Q1 Viedoc 4 demo

Year 2014

June 2019DB Lock

Design Version # 45

Iterative design … for an exploratory study.

Sept. May

Mock-up CRF (Ipsen)

Design Version # 1

Jan. 2015Go live

Prototype development (PCG) / UAT (Ipsen)

Design Version # 25

+20 review cycles

Challenges during study conduct

Subject - Internal Ipsen/ External Ipsen/ Confidential Ipsen/ Highly confidential Ipsen (delete unnecessary mentions)16

03

17

Challenges due complexity of CRF design03

Many questions from sites / Monitors Some forms triggered in error / Forms not triggering Which item should I update to trigger the missing form? How to delete a form? How to reset or refresh a form?

Training & documentation +++

18

System performance issues03February 2017 (almost all patients in)

• Some investigators complained about the system performance• Same issue as a sponsor• Viedoc team contacted

Implementation of a corrective action plan : new version released where major performance improvements have been made + technical tweaks and…

15-FEB-2017 09-MAR-2017

Open study “ULIS III” 10 s 1.8 s

See patient cards (click on “Launch”)

16 s 5.8 s

Open a patient card 10 s 2.5 s

TOTAL 36 s 10.1 s

Outcome

19

04

Achievements04

Database locked in June 2019 2 interim analyses performed Final analysis :

Final results presented to KOLs on 12-DEC-2019 Abstracts & Posters

On baseline data First cycle data

One manuscript on going (on First cycle data)

21

Achievements04

Proof of concept Impossible to make it paper

Full paper CRF : 7,000+ pages

Viedoc 4 able to address our requests System performance met our expectations

22

Achievements04

ULIS III paved the way for a sister study : AboliSh (Spasticity in Lower Limb) Same design for primary endpoint, some forms re-used, lessons learnt

Subject - Internal Ipsen/ External Ipsen/ Confidential Ipsen/ Highly confidential Ipsen (delete unnecessary mentions)23

Thank youQuestions