What the challenges are to switch to risk based monitoring and its implementation

1. Dr.Ralf Kaiser, Consultant Clinical Operations

2. WTF ?
Dr.Ralf Kaiser, Consultant Clinical Operations

3. Risk based monitoring (RBM) is only a part
of an important entire system of risk
management and quality of a clinical trial
Dr.Ralf Kaiser, Consultant Clinical Operations

4. Dr.Ralf Kaiser, Consultant Clinical Operations

5. Challenges
Dr.Ralf Kaiser, Consultant Clinical Operations
REVOLUTION
?

6. Challenges (1)
 « Brainwashing » because the paradigm of clinical trials
will change the actual manner of management of clinical
studies (« brain hacking »)
 Approval of the new system by the Pharmaceutical
Industry
 Negative perception => « risk based » (cf. Stephen
Young, « rebranding RBM »)
 Rethink the R&D at a whole
 Rebalance the responsibilities throughout the
development process of study protocols (and even of
the projects)
Dr.Ralf Kaiser, Consultant Clinical Operations

7. Challenges (2)
 Approval of the new system by the Investigator sites
 Data entry in real time
 Training of study personnel to new technical
approaches and to evolutive systems
○ Who is responsible for this ? Additional time
needed of already overwhelmed personnel
 Communication between different departments
(Pharmacy, Radiology,… etc.) necessary
Dr.Ralf Kaiser, Consultant Clinical Operations

8. Challenges (3)
 Pertinent data to be determined since the start of study
protocol writing
 Key data triggering alerts – Trend analyses
 Feasibility process more rigorous
 Benchmark on Investigator sites
 Better choice of sites
 Investigator’s dossiers not authorised actually
 Redesign of the actual EDC system into a proactive
tool, provide more time before the start of a study
 Continued data analyses
 Web based data base
Dr.Ralf Kaiser, Consultant Clinical Operations

9. Challenges (4)
 Change management programme expensive (sponsors)
 Persistent doubts by the sponsor about the data quality
 Several systems/technologies co-existing and not
compatible with one another (CRO/Sponsors)
 New hierarchy during the development process of a
protocol (Data Management with a more preponderant
role) vs actual (Project Manager, Medical, CRA).
Dr.Ralf Kaiser, Consultant Clinical Operations

10. THE FUTURE
Dr.Ralf Kaiser, Consultant Clinical Operations

11.  Short range (1-2 ys): implementation of a system/software
allowing to set-up rapidly a program with key data alert
 Mid range (2- 5 ys): several systems will be used by the
sponsors/CROs feeding a common data base/country (CA)
 Long range (>10 ys) : Data base (Big Data) accessible by all
research entities involved in clinical research but with
specific authorisation, managed in common by all members
of the Global Competent Authorities ( i.e. FDA, EMA, Chine,
Japan)
 Very long range (>20 ys) : no more clinical trials according to
the actual model but it appears conceivable to use instead
the Big Data and only confirmation studies with a limited
number of subjects/volunteers will be conducted.
Dr.Ralf Kaiser, Consultant Clinical Operations

12. The Future ?
Sponsor 3
Clinical trial 3
Sponsor 2
Clinical trial 2
Sponsor 1
Clinical trial 1
Web based
BIG DATA
C
CA Countries
FDA/EMA/Chine
Japan/?
CA = Competent Authority
Dr.Ralf Kaiser, Consultant Clinical Operations