1. Torsten Chandler Health Economist
Institute of Clinical Trials and Methodology & Comprehensive Clinical Trials Unit
Hi Everyone,
My name is Torsten. I'm a Health Economist at the Comprehensive Clinical Trials Unit which sits within the Institute of Clinical Trials and Methodology.

2. Content The Institute of Clinical Trials and Methodology
Role of a Clinical Trials Unit
Health economics at ICTM
Trials with economic evaluation
Economic evaluation alongside trials
Key challenges
Current & future collaboration
Current studies
Conclusion
Today I'm to talk to you about going to talk to you about:
The Institute of Clinical Trials and Methodology and the trials units within it
Role of a Clinical Trials Unit
Health economics at ICTM – How health economics fits within the ICTM framework?
I'm going to give you a breakdown of the number of trials with a health economics component
I'm going to talk more generally about Economic evaluation alongside trials
And a number of key Key challenges
I'm going introduce some of the Current & future collaboration that is taking place at within the institute
I’m going to introduce 2 Current studies ongoing at the CCTU
And Ill finish with a Conclusion

3. The Institute of Clinical Trials and Methodology
The Institute of Clinical Trials and Methodology - Centre of excellence
The Institute is part of the Faculty of Population Health Sciences in the School of Life and Medical Sciences, and is comprised of four clinical trials units:
ICTM is a centre for excellence for clinical trials, over a range of conditions. The Institute is comprised of 4 trials units:
The Comprehensive Clinical Trials Unit (where I am based), the MRC Clinical Trials Unit
And two virtual members
PRIMENT Clinical Trials Unit which Rachael will be introducing later today and the Cancer Research UK & UCL Cancer Trials Centre.

4. Clinical Trials Unit (CTU) Support
PLANNING
SET-UP
CONDUCT
ANALYSIS
REPORTING
PUBLICATION
Study design
Sample size
Feasibility
Costings
Application review
Sponsor liason
Protocol development
Database/CRF development
Randomisation
Obtaining approvals
Contract negotiation
Site feasibility
Trial/data management
Adverse event management
Monitoring
Trial meetings
Quality assurance
Statistical analysis
Statistical monitoring
Funder reports
TSC/DMEC reports
End of trial notifications/ reports
Advice and consultation
Scientific writing
What does a clinical trials unit do?
A CTU offers support Provides support at each stage, from study design and application through to conducting the study, reporting the results and publication.

5. Health Economists at ICTM
Currently Comprehensive Clinical Trials Unit and Priment are the only trials units to have health economists at UCL
ICTM has approximately 400 staff with 4 health economists (as far as we know)
1 Health Economist at the CCTU
3 Health Economists at Priment
Other key collaborators
So how do health economists fit into the ICTM framework?
Currently there are only health economists placed within the CCTU and PRIMENT.
Out of approximately 400 staff at the ICTM. There are 4 health economists working over (a number) trials - So a relatively small team.
I've provided a breakdown here
1 health economist at the CCTU
3 Health economists at PRIMENT
I should mention there are also a number of other key collaborators. I know Steve Morris and Gianluca work very closely with the trials units on a number of studies.

6. Trials with economic evaluation
27 active trials, 23 of which have a health economics component.
25 active trials, 5 of which have a health economic component.
I've provided a break down here of trial with and without health economics.
27 active trials, 23 of which have a health economics component.
25 active trials, 5 of which have a health economic component.
Next slide:
The number of trials reflect the demand from funding bodies

7. Economic evaluation alongside trials
UK funding bodies consider health economics an important component of research and research proposals
Increasingly data for economic evaluations is being collected in trials (medical service use, costs and effects)
Considering health economics evidence is a mandatory part of NICE clinical guidelines and technology appraisals
Health economists in trials units are primarily concerned with economic evaluation alongside trials
Clinical trials can establish the efficacy and effectiveness of health care interventions or therapies
Its UK funding bodies consider health economics an important component of research and research proposals
In the UK MRC and NIHR routinely expect cost effectiveness analysis to be incorporated in large scale trials
Increasingly data for economic evaluations is being collected in trials (medical service use, costs and effects)
Typically economic evaluations (CEA or CUA) are incorporated into phase 3, 4 trials and sometimes into phase II
In terms of the wider policy context health economics evidence is a mandatory part of NICE clinical guidelines and technology appraisals

8. Economic evaluation alongside trials
Key challenges
Analysis has to be planned around primary outcome
Sample size required for economic questions may be larger
Comparator may not be most commonly used/cost effective treatment
Follow up required to address economic questions may be longer than to answer clinical questions (modelling?)
Dealing with missing data & censored data - Resource use forms can be time consuming.
Health economics may not be the priority interest of PIs and CIs
So I've talked about the aims of economic evaluation alongside trials, but what about the challenges?
Key challenges
Analysis has to be planned around primary outcome which is often of a clinical nature and not an economic one
This can have consequences for
Often no say in sample size calculation
Comparator may not be most commonly used treatment which is important for cost effectiveness?
Follow up required to address economic questions may be longer than to answer clinical questions –
modelling may be needed to fully assess all implications of costs and effects of the treatment. However funding may not always be available for this!
Resource use forms can be time consuming leading to Missing data which needs to be dealt with in an appropriate way
An it may come as no surprise, but Health economics may not be the priority interest of PIs and Cis

9. Current & future collaboration
Seminars
PRIMENT Statistics, Health Economics and Methodology Seminar
Methodologist meetings
Team meetings
Joint publications & working documents
Future?
I'm now going to talk about the current collaboration between units in the Institute
There a range of seminars including the Priment Statistics, Health Economics and Methodology Seminar and a methodologists meeting which brings together health economists, statisticians and trialists to discuss current and future studies.
Team meetings –For example, I've been joining the health economists at Priment to discuss, workload, upcoming conferences in the field.
Joint publications & working documents can encourage collaboration between researchers despite them necessarily sitting with the same department field.
In future I would like to see more collaboration with providers of routine data such as CPRD and HES data where a whole wealth of useful data is available.

10. Current studies – FACT trial
A Randomised, Single Masked, Non-Inferiority Trial of Femtosecond Laser Assisted vs Manual Phacoemulsification Cataract Surgery for Adults with Visually Significant Cataract: the FACT trial
Analysis planned: Early economic model, within trial analysis and lifetime model
Funding source: NIHR HTA
Unique aspect: 2 eye problem
I'm now going to briefly talk about a few of the trials running at the CCTU with a health economics component along with the analysis planned, the funding source and unique aspect of each trial form an HE point of view
Firstly, the FACT trial is a , Single Masked, Non-Inferiority RCT investigating the use Laser Assisted vs Manual Phacoemulsification Cataract Surgery
Health economic work includes an early economic model before recruitment and follow up is finished, a within trial analysis and a longer term decision model.
The trial is funded by the HTA programme run by the NIHR.
A unique aspect of the trial is that some (but not all) patients receive cataract surgery in both eyes. For example, patients QoL may improve significantly more after their first cataract is removed than following surgery on their in the second eye.
This needs to be considered in data collection and modelling the problem.

11. Current studies – ATTIRE trial
ATTIRE: Albumin To prevenT Infection in chronic liveR failurE
A trial to investigate whether giving albumin to patients admitted to hospital with advanced liver cirrhosis will reverse immune suppression and improve outcome from infection.
Analysis planned: Within trial analysis and lifetime model.
Funding source: Department of Health and Wellcome Trust
Unique aspect: Patient population & re-randomization of patients
The ATTIRE trial investigates whether giving albumin to patients admitted to hospital with advanced liver cirrhosis will reverse immune suppression and improve outcome from infection.
The health economic analysis planned includes a within trial analysis for a 6 month period and a lifetime model.
The trial is jointly funded by Department of Health and Wellcome Trust
A unique aspect of the trial is the
Patient population, patients with advanced liver cirrhosis are often alcoholics which represent a difficult patient population to follow up. To tackle this we are applying for a range of data items from the Health & Social Care Information Centre (now NHS digital) on hospital episodes.
In addition the trial allows patients to be re-randomised based on the relatively short wash out period of albumin. However the follow up of economic data is interrupted for re-randomized patients, potentially introducing bias unless accounted for.

12. Conclusion
Team of health economists at the Institute is small, but open to collaboration and growth
UK funding bodies consider health economics an important component of research proposals
Designing trials with an economic evaluation can facilitate direct observation of costs/effects
However long term modelling often required
Team of health economists at the Institute is small, but open to collaboration and growth
UK funding bodies consider health economics an important component of research proposals
Designing trials with an economic evaluation can facilitate direct observation of costs/effects
However long term modelling often required – if funding is available.

13. Useful links
Institute of Clinical Trials and Methodology Comprehensive Clinical Trials Unit Priment Clinical Trials Unit