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Presentation: Evaluating risk minimisation effectiveness: Where are we now?
TGA presentation: ARCS Scientific Congress Sydney, 11-12 May 2016
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- Presented by: Elspeth Kay, Director, RMP Evaluation Section, Pharmacovigilance and Special Access Branch
- Presented at: ARCS Scientific Congress Sydney
- Presentation date: 11-12 May 2016
- Presentation summary: Challenges of risk minimization activities and strategies for overcoming them with reference to emerging published literature and real-life examples
Evaluating risk minimisation effectiveness
Director, RMP Evaluation Section
Pharmacovigilance and Special Access Branch
ARCS Congress 2016
Slide 1 - Overview
- Why is risk minimisation evaluation important?
- What does TGA look for?
- What has been the experience in Australia?
- Where would we like to be?
Slide 2 - Why is evaluation important?
Have the risk minimisation activities worked? If not, why not?
Input: sponsor, regulator, experts, HCPs, consumers → Risk minimisation activities → HCP and/or consumer knowledge → Minimal occurrence of ADR
Slide 3 - Risk management cycle
Risk management cycle
- Data Collection
- monitor effectiveness and collect new data
- Identify & analyse
- risk quantification and benefit assessment
- benefit risk balance and opportunities to increase and/or characterise
- Select & plan
- risk characterisation /minimisation and benefit maximisation techniques
- risk minimisation /characterisation and benefit maximisation
Slide 4 - What does TGA look for?
In the evaluation plan
- Is the evaluation plan well described in RMP/ASA?
- Which parts of the program going to be evaluated and why?
- Are the measures and timeframes clearly defined and appropriate?
- Is the methodology suitable and feasible?
- Has consideration been given to how success will be defined?
In the evaluation reports
- Was the evaluation carried out as intended?
- Is there a conclusion about whether the risk minimisation activity should change, continue as is, or cease?
- Is the conclusion well supported by the information presented?
Slide 5 - Resources
- EMA Guidelines on good pharmacovigilance practices Module XVI
- CIOMS IX report: practical approaches to risk minimisation for medicinal products
Slide 6 - Risk minimisation evaluation framework
CIOMS IX risk minimisation evaluation framework
- 1. Programme (go to step 2 or 3)
- 2. Outcome indicators to evaluate the programme success (safety related outcome of interest).
- Morbidity/mortality EP
- Composite EP
- Surrogate EP
- Biomarker EP
- (go to step 4)
- 3. Single or several interventions (go to step 6)
- 4. Programme successful?
- Yes : Continue programme (or provide justification to discontinue)
- No : Improve interventions or programme design based on process indicator feedback (go to step 5 or 6)
- 5. Potential moderators
- Comprehensiveness of strategy description
- Strategies to facilitate implementation
- Quality of delivery
- Participant responsiveness
- (go to step 6)
- 6. Process indicators to evaluate implementation fidelity of each intervention
- (go to step 2)
Note: EP = endpoint. The 'CIOMS IX risk minimisation evaluation framework' outlines elements to be considered for the evaluation of a risk minimisation programme (modified from Carroll (25).
Slide 7 - RMPs evaluated for Type A applications in 2015
Slide 8 - Common challenges
- Evaluation plans not developed before registration
- Description of evaluation lacking necessary detail
- Poor response rates to surveys
- Uncertainty about how to evaluate consumer-directed activities
- Use of process indicators without consideration of outcome indicators
Slide 9 - Where would we like to be?
- Clear and comprehensive description of evaluation plan
- Consideration of a number of measures, not just knowledge and awareness
- Use of outcomes data
- Evaluation of consumer-directed activities
- Well-justified goal for success
- Sharing experience through publication/dissemination