Risk-Based Monitoring

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1 Risk-Based Monitoring Evolutions in monitoring approaches Voorkomen is beter dan genezen! Roelf Zondag 1

2 wat is Risk-Based Monitoring? en waarom doen we het? en doen we het al? en wat is lastig hieraan? 2

3 Waarom Risk-Based monitoring? Bijv. FDA guidance document Trial complexity Investigator experience variability Site infrastructure complexity Regulatory scrutiny Development cost Competition for subjects Post approval commitments The primary focus should be on the processes that are critical to protecting human subjects, maintaining integrity of study data and compliance with applicable regulations I N C R E A S I N G Observations / findings should be used to correct investigator and site practices 3

4 Waarom Risk-Based monitoring? Omdat we niet alles kunnen checken We hebben geen ongelimiteerde resources budget planning Omdat we complexe processen hebben Quality scope Conclusie: We moeten slim zijn en dat doen wat er toe doet, dus inzicht in de processen hebben en zien waar de risico s zitten 4

5 5

6 Wat is een proces? Meet gegevens Input Output Patient dient zich aan Patient heeft consent gegeven en doet mee met de studie. Beinvloed het proces zoek de route cause Helaas is de verkeerde versie van het ICF gebruikt en ontbreekt de datum 6

7 Risk-Based monitoring Data-driven Trial Execution begins with an in-depth risk assessment where a team of experts evaluates the scientific and operational risk of each protocol. Data / Systems Data surveillance allows the optimization and the adaptation of monitoring throughout the trial, re-assessing risk and applying the right action at the right time. We use the right type of monitoring at the right time (on-site, remote, centralized), monitoring sites, data, patients and events that require more attention and focus. 7

8 Triggered monitoring Enrollment In current practice many clinical monitoring plans require site visits to take place every 4, 6, or 8 weeks Triggers may be work volume based or risk management based Patient safety Defined patient visit number Models have become more sophisticated over time with site visits being pooled for use across studies/programs and scheduled based on work volume triggers Triggers are defined based on specific protocol features and requirements Data review risk indicators Site Visit Triggers Data quality indicators Page volume This model allows for a more dynamic management of monitoring resources by scheduling visits based upon an algorithm of pre determined triggers that initiate a monitoring visit only when there is a need 8

9 Risk Management 9

10 Wie houdt er een risk log voor zijn studie / sites bij? 10

11 Risk Management > Systematic process of planning for, identifying, analyzing, responding to, and monitoring project risk > Involves processes, tools & techniques helping the manager minimizing the probability and consequences > RM is most effective when performed early in the life of project or program and is a continuing responsibility during the program or project > Managers should plan time to identify and manage risk and issues and maintain a risk register /risk log 11

12 What is a Risk? Event / condition that did not happen yet Effect on achieving an objective A risk has a cause Risk is uncertain (has a probability) A risk has a consequence (impact) Prevention 12

13 What is an Issue? Event / condition is happening Effect on achieving an objective An issue has a cause An issue has a consequence (impact) Solving 13

14 Benefits of Risk Management Hard Benefits Soft Benefits Enables better plans, schedules and budgets Better contingencies view Discourages unsound financial projects Better management of future projects More objective view of alternatives Provides cost/benefit analysis Gives information for management decisions It avoids crisis management Improves communications Improved team spirit Helps staff to assess risks Can focus on real/vital issues Enables greater risk taking Looks good from a customer/partner viewpoint 14

15 Risk Management Process Risk assessment > Risk Management Planning > Identify possible risks and their description Risk analysis (qualitative / quantitative) > Assess risk probability > Asses risk impact Risk management > Risk response planning (proactive & reactive measures) > Risk monitoring and control (risk watch list / risk log) 15

16 Define events / conditions use risk categories approach 2. Risk Identification 3. Qualitative Risk Analysis probability & impact 1. Risk Management Planning Risk Management Processes 4. Quantitative Risk Analysis 6. Risk Monitoring & Control 5. Risk Response Planning metrics & triggers avoidance transference mitigation acceptance contingencies 16

17 Risk log content Risk Title Risk Description Probability Impact Exposure Trigger Effect Mitigation Contingency Cost of mitigation / contingency (short text, SMART - principles) (description, SMART-principles) (high, medium, low) (high, medium, low) (probability*impact) (metrics) (description of the impact) (preventive action) (corrective action) 17

18 Exposure Impact / Probability Low (1) Medium (2) High (3) High (3) Medium High Unacceptable Medium (2) Low Medium High Low (1) Low Low Medium Exposure = Probability x Impact 18

19 Risk, Site A Title > There is a probability that the contract of site A will not be signed before date xxx Description > There is a probability that the site contract of site x will not be signed before date xxx due to the communication loops between. legal and the legal department of the site. This will impact patient recruitment. Probability = medium, Impact =high Trigger > If contract is not signed one week before official planned SIV Effect > As this is a key enrolling site and is on the critical path, patient recruitment will be delayed by 4 weeks meaning the current planned enrolment will not be met and enrolment period must be extended. It is estimated that 10 patients will be missed if the enrolment period stays unchanged. 19

20 Risk, Site A Mitigation > Facilitate the contract negotiation process by setting up a TC between legal of the hospital and legal of.. avoiding communication and promote direct contact. > When a new version of the contract is available actively follow up the site to check the review status of the contract. Contingency > to activate backup site B to provide an additional 10 patients so the enrolment period does not have to be extended. > Extend the enrolment period for Site A Costs > Mitigation costs are estimated at 0 Euro. Backup site scenario will cost Euro. > Change enrolment period will cost 0 Euro when looking at global timelines 20

21 Conclusie Risk management Professionaliseer Gebruik systemen en de informatie uit systemen (metrics) Proces georienteerd Root cause analysis Gebruik systemen en de informatie uit systemen (metrics) Project Triangle Site manager Pro-actief Trends 21

22 Quiz In this new paradigm: in order to verify protocol & GCP compliance, is it better 1. to do Source Data Verification (SDV)? 2. to do Site Process Verification (SPV)? 3. to do a mix of SDV and SPV? 22

23 Consequenties Meer electronische integratie ecrf, CTMS, EPD, Data Warehouse Gereduceerde SDV en meer Site Process Verificatie Verschuiving naar central monitoring vs onsite monitoring meer telefonische opvolging Data management functie merged met CRA functie Operationeel, medisch, over sites en landen heen kijken Dashboards met data & signals Data gedreven besluitvorming Triggered monitoring Eindpunten, Missing data, Safety, outlayers.. 23

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