SLIDE 1 HSRU is funded by the Chief Scientist Office of the Scottish Government Health
- Directorates. The author accepts full responsibility for this talk.
Health Services Research Unit University of Aberdeen
Collaborating to combat the inefficiency of randomised trials
Heidi Gardner
@heidirgardner heidi.gardner.10@aberdeen.ac.uk
SLIDE 2
- Financial efficiency: use of resources – technology, staff
- Scientific efficiency: establishing need, the ‘right’ question, optimal
design
- Regulatory efficiency: the ‘amendment cascade’, repetition in
approvals documentation
- Integration of knowledge: at the beginning – PPI, multiple
stakeholders, at the end – dissemination to the research community and healthcare providers, public engagement
- Process efficiency: recruitment, retention, data collection
What is an efficient trial?
SLIDE 3
- Approximately 25,000 trial results published every year1
- The number of things we measure is increasing2
- Data collection takes time and effort – patient burden as well as staff
- Data management accounts for a lot of work; one estimate is that
- ver a third of hours spent on a trial is spent by Data Managers3
- 1. Bastian et al. PLoS Med. 2010; 7: e1000326
- 2. Getz et al. Am J Ther. 2008; 15: 450-7
- 3. O’Leary et al. Clinical Trials. 2013; 10: 624-32
Trials = Data
SLIDE 4
Are these data informing decisions?
SLIDE 5
Are these data informing decisions?
SLIDE 6
- Primary/secondary outcome data, health economics outcomes,
process outcomes, compliance data, participant identification, eligibility, demographics, safety data, data management items
- Where do we invest our time when collecting outcome data?
- Do we spend most of it on our most important outcomes?
- Project led by Prof Shaun Treweek, Aberdeen and David Pickles,
Leeds
What are we collecting and why?
SLIDE 7
Ongoing international trial: Time
3% on primary 85% on secondaries 12% on biomarkers Primary = 81 hours Biomarker = 324 hours Secondaries = 2265 hours Total = 2670 hours A working year? ~1725 hours
SLIDE 8
Ongoing international trial: Cost
3% on primary 85% on secondaries 12% on biomarkers Primary = £2,106 Biomarker = £8,424 Secondaries = £58,890 Total = £69,420 A research nurse in Grampian costs around £26 per hour
SLIDE 9
- Random selection of 115 protocols for publicly funded RCTs
published between 2010 and 2014 (~24 per year)
- Primary and secondary outcomes extracted from protocols
- Data on time to complete each outcome sought from protocol,
corresponding authors, or Trial Managers familiar with the outcome
- We’ve looked at 20 trials so far
Let’s look at a bigger sample
SLIDE 10
A sample of 5 trials
Hours Trial ID
SLIDE 11
A sample of 5 trials
Hours Trial ID
SLIDE 12
..and for 20 trials
Hours Trial ID
SLIDE 13
..and for 20 trials
Hours Trial ID
SLIDE 14
Primaries and secondaries: Median time and cost
14% on primary 86% on secondaries Primary 68 hours / £1,785 Secondaries 417 hours / £10,946 Total 485 hours / £12,731
SLIDE 15
Median ratio of time spent on primary vs secondary outcomes
A ratio to remember
SLIDE 16
- Collaborative project
- Identify processes
- Collate what we know
- Spot gaps
- Do work to fill those gaps
- Disseminate
What is Trial Forge?
SLIDE 17
SLIDE 18 Special thanks to Prof Shaun Treweek, Aberdeen & David Pickles, Leeds
HSRU is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The author accepts full responsibility for this talk.
Thank you!
@Trial_Forge
www.trialforge.org
