1. Exeter Clinical Trials Support Network Event 13
Wednesday 7th June 2017
10:30
Refreshments: Coffee &Cake
10:40
Introduction (5mins)
Shelley Rhodes - ExeCTU Senior Trial Manager
Anthony Asindi - ExeCTU Quality and Contracts Manager
10:45
Clinical trial Data Programming & Management. What can ExeCTU do for you? (30mins) ExeCTU Data Programming Team:
Tim Eames, Mary Davis & Sofia Sanabria
11:15
Q&A followed by networking (30mins)
11:45
Data Archiving & Open Access Case Study – The COBRA trial (15mins)
Shelley Rhodes – ExeCTU Senior Trial Manager (formerly COBRA Trial Manager)
12:oo
Q&A followed by networking

2. Core CTU Staff: … and new staff: Bethan Knight CTU Admin Support
Exeter CTU launched yesterday – nicked the slides
… and new staff:
Bethan Knight
CTU Admin Support

3. Data Archiving & Open Access Case Study- The COBRA Trial
ExeCTU Senior Trials Manager
Shelley Rhodes
JS01 Smeall, St Lukes Campus.

4. Recap- ECTSN event 12 Data Management: The New Frontier for Libraries
Greg Simpson – Research Data Officer
slides available here:
Archiving Clinical Trial Analogue Data
Claire Bewshea, Exeter IBD and Pharmacogenetics Project Manager
slides available here:

5. Example Gantt Chart - COBRA
NIHR open access policy change
development
Set up
Completion
Conduct

6. Info from those two talks that were relevant to COBRA funded
Revised in April 2014, NIHR policy on Open Access now covers not only published peer-reviewed research articles, but also the research materials – such as data, samples and models – that underpin them.
All NIHR researchers are now required to prepare and submit a statement on how underlying research materials, such as data, samples or models, can be accessed.
Although the NIHR expects researchers to consider and plan for data access, the policy does not require that data must be made open, nor does it specify how long data must be retained for.

7. The COBRA Trial Main trial out come paper:
Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet
And also trial methods paper and a qualitative study published.
Data analysis still in progress:
Process evaluation
Therapist qualitative analysis
Participant Therapy tapes analysis of sudden gains

8. Data Sharing Statement
In Lancet paper? No!
In HTA report:
The authors confirm that all data underlying the findings are fully available without restriction. The authors have made the clinical and economic data set available through the University of Exeter’s Institutional Repository – Open Research Exeter (see Access to these data is permitted but controlled through requests made via the repository to the chief investigator (Professor Richards: Although use is permitted, this will be on the basis that the source of the data is acknowledged (including the funder) and it includes reference to the data set ‘handle’.

9. What data are we talking about? Main (Primary) outcome data
Source data = paper case report forms (CRFs)
440x4visits=1760 CRFs, each about 61 pages long
Currently fill 8 filing cabinets
Data entered into Trial Database
Data downloaded as excel spread sheet
data dictionary, 1808 variables, 25 tabs
Data analysed in STATA
“Do” files saved
Results published in main study paper and will be uploaded to ORE

10. Depositing in ORE
Open Research Exeter, example of an Institutional Repository
DSpace software – current version 4.2
Can use Symplectic for data deposits if less than 1GB
SSO authentication

11. …and Source data collected from therapists via paper self report CRFs
Data entered into excel spread sheets by research staff
Data analysed in STATA
Results published in main study paper and so will be deposited in ORE

12. Trial Closure takes longer than anyone wants it to take!
Site close out activities at each site:
Check site file (s)
Resolve all data queries
Not long (1 week) as was kept up to date
Much longer (6 months) due to additional data collection

13. …and Therapy Session audio recordings
Source data collected via audio tapes of therapy sessions – 3915 x 1hr sessions
Data uploaded from audio recorder to UEMS server
Transferred to two data analysts one in Oxford and one in USA (temporary).
Data (scores) returned to Exeter
Audio transferred to 2 sets of DVDs for storage in archive room.
Results published in main results paper
Continued current access needed to data for sudden gains analysis so Data currently being uploaded off DVDs again
However no plans to make this open access.

14. …and Qualitative Interviews
Qualitative interviews (QI) with patients and therapists
Recorded and uploaded to UEMS server
Transcribed by contractor and documents archived
Patient QI Analysed & Results published: Finning K, Richards DA, Moore L, et al. Cost and outcome of behavioural activation versus cognitive behavioural therapy for depression (COBRA): a qualitative process evaluation. BMJ Open 2017;7:e doi: /bmjopen
Data sharing statement No additional data are available.
Therapist QI data analysed and paper currently being written:
No plans to make source data available

15. Take home message (s) Use a Trial Data base
Minimal data cleaning required
Record statistical analysis process in “Do” file or similar
Upload to ORE or other suitable depository
Build in sufficient time at the end of the trial for this

16. Aims to facilitate the development of a well-trained, highly motivated, effective workforce of trial managers within the UK health care system who will make an important contribution to the efficient delivery of high quality clinical trials.
It aims to provide a forum which will promote best practice in effective management and delivery of clinical trials, and provide a focus for the professional accreditation of the competencies required to effectively manage a clinical trial and thereby developing a career pathway for trial managers.
UKTMN also seeks to promote a shared understanding of the role and value of effective trial management within clinical research.
A guide to Efficient Trial Management