Trial Forge: working together to make trials more efficient Shaun - - PowerPoint PPT Presentation

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Aug 28, 2023 185 likes •578 views

Trial Forge: working together to make trials more efficient Shaun Treweek Twitter: @shauntreweek streweek@mac.com Health Services Research Unit University of Aberdeen HSRU is funded by the Chief Scientist Office of the Scottish Government

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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

Trial Forge: working together to make trials more efficient

Shaun Treweek

Twitter: @shauntreweek streweek@mac.com

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Let’s do a trial

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Let’s do what we did last time..

‘There is a peculiar paradox that exists in trial execution - we perform clinical trials to generate evidence to improve patient

utcomes; however, we conduct clinical trials like anecdotal

medicine: we do what we think works we rely on experience and judgement and.. limited data to support best practices.’

Monica Shah in ‘Site selection in global clinical trials in patients hospitalized for heart failure: perceived problems and potential solutions’. Heart Failure Review 2014; 19:135-52.

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And there’s more..

The way we design a trial often makes it hard to: do the trial convince others, especially those we hope will use the results, that those results are relevant

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Example 1: participants

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A strangely familiar graph..

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What helps recruitment?

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What helps recruitment?

3 things

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What helps retention?

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What helps retention?

3 things

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Example 2: data collection

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Example 2: data collection

3% on primary 85% on secondaries 12% on biomarkers

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Example 2: data collection

3% on primary 85% on secondaries 12% on biomarkers Primary = Biomarker = Secondaries = Total = 81 hrs 324 hrs 2265 hrs 2670 hrs A working year is about 1725 hrs

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Example 2: data collection

3% on primary 85% on secondaries 12% on biomarkers Primary = Biomarker = Secondaries = Total = £2,106 £8,424 £58,890 £69,420 A research nurse costs around £26 per hour

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But we collect so much data..

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But we collect so much data..

82% unused

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So, what to do?

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Trial Forge - simple steps to a big change

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Stuff you can use

Telephoning people who do not respond to mailed invitations to take part in a trial probably increases recruitment.

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Stuff you can use

Telephoning people who do not respond to mailed invitations to take part in a trial probably increases recruitment.

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Trial Forge demonstrators

Design: matching design to intention Recruitment: how should we select sites for trials? Data collection: how much time do we spend collecting data? Studies within a trial (SWATs)

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Design: PRECIS-2

Who am I designing my trial for and what have I done to make sure they don’t have to dismiss my trial as irrelevant? Who are your users and what do they want?

Kirsty Loudon, Stirling

Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for

purpose. BMJ 2015; 350: h2147–7.

SLIDE 25 O R G A N I S A T I O N

h a t e x p e r t i s e a n d r e s

r c e s a r e n e e d e d t

e l i v e r t h e i n t e r v e n t i

? ELIGIBILITY - Who is selected to participate in the trial? S E T T I N G

h e r e i s t h e t r i a l b e i n g d

e ? RECRUITMENT - How are participants recruited into the trial? FLEXIBILITY: DELIVERY - How should the intervention be delivered? FLEXIBILITY: ADHERENCE - What measures are in place to make sure participants adhere to the intervention? F O L L O W

c l

e l y a r e p a r t i c i p a n t s f

e d

p ? PRIMARY OUTCOME - How relevant is it to participants? PRIMARY ANALYSIS - To what extent are all data included?

1 2 3 4 5

Design - PRECIS 2

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RECRUITMENT: how to select sites?

Most trials need to select several sites Many of these will fail to do what they are supposed to do (especially recruit) Evidence on how to best select sites is thin

Estimating Site Performance (ESP) study

Kirsty Shearer, Seonaidh Cotton, Anne Duncan, Hanne Bruhn Aberdeen

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Data collection: time spent

Where do we invest our time when collecting

utcome data?

Me, Aberdeen & David Pickles, Leeds

Do we spend most of it on our most important outcomes?

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Example 2: data collection

3% on primary 85% on secondaries 12% on biomarkers Primary = Biomarker = Secondaries = Total = 81 hrs 324 hrs 2265 hrs 2670 hrs A working year is about 1725 hrs

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Filling evidence gaps: SWATs

Mike Clarke, Belfast

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Summary

To a large extent, we do trials the way we do because that’s

the way we do them.

The chances are that we can do better than this through

more collaboration and coordination.

Through Trial Forge we want to move beyond saying how

grim everything is and start working on solutions.

Join up! (or at least follow @Trial_Forge..)

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Time to consider new wheels..

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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!

Twitter: @Trial_Forge

http://trialforge.org

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The PS: crowdsourcing methodology research?

How much time do we spend collecting trial

utcome data?

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The PS: crowdsourcing methodology research?

How much time do we spend collecting trial

utcome data?

Created page, tweet on 4/4; response on 5/4; project taken on 10/4. Now part of an MSc project.

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Protocol 2014: each measured twice

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Protocol 2014: each measured twice

1 measurement 17 measurements

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Protocol 2014: each measured twice

1 measurement 17 measurements 23 full days

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Protocol 2014: each measured twice

1 measurement 17 measurements 23 full days 276 full days