1. Depression: Improving Recruitment into Clinical Trials David A Richards, Professor of Mental Health Services Research

2. DiReCT Team David A Richards, Principal Investigator – d.a.richards@exeter.ac.uk d.a.richards@exeter.ac.uk Sarah Ross, Project Manager – sarah.ross@exeter.ac.uk or sarah.ross@exeter.ac.uk Lucy Evans, Project Administrator – l.evans@exeter.ac.uk l.evans@exeter.ac.uk Barney Dunn, Associate Professor – b.d.dunn@exeter.ac.uk b.d.dunn@exeter.ac.uk

3. Background Embedding research in clinical services is a core function of the NHS National policy states that any eligible patient will be offered the opportunity to participate in clinical research Currently, patients with depression do not get this chance Most trials recruit less than 10% of eligible participants Only 30% of trials for depression recruit to target and on time

4. Benefits for basic science Similar recruitment challenges for basic science Cohort provides an excellent framework for: 1. large scale prospective cohort 2. large scale genetics studies 3. recruitment into smaller experimental studies 4. service user involvement in research planning Potential to integrate work in the laboratory and the clinic

5. Summary DiReCT is developing and testing the Cohort Multiple RCT’ (cmRCT) system* as a systematic recruitment method for participants with depression into clinical research, including observational studies and randomised controlled trials (RCTs) of psychological treatments. * Relton et al, BMJ, 2010

6. Current Practice MRC/NIHR-EME CADET Trial

7. DiReCT Aim The establishment of a cohort of patients with depression in Devon who agree to participate in clinical research Pre-consent patients to de-anonymisation of routine data, consent to research interview and random selection into clinical trials Use huge numbers of patients referred to local IAPT service (approx 11,000 pa) as recruitment population for cohort sample

8. Proof of principle tests The ETHICS TEST: – how ethically acceptable is the proposed cmRCT system? The RECRUITMENT TEST: – what proportion of NHS patients with depression will agree to join the DiReCT cohort? The TRIALS TEST: – how many patients in the DiReCT cohort would consent to being randomly selected to receive new treatments?

9. Plan Advisory group – Ethicists, public and patient involvement, trialists, commercial partners, research funders, operational services, research networks Ethics application test – ? four stage consents – (anonymised data), de- anonymisation and contact, cohort data collection, random selection

10. Plan (2) Cohort pilot recruitment test – In Exeter, Devon – Outcome is proportion of patients a) consenting to each stage and b) entering cohort % of de-anonymisation and ‘consent to contacts’/total service assessments % of patients in cohort data collection % of patients consenting to random selection

11. Questions Who takes consent? What is acceptable consent to patients (IOP?) What extra data is required for cohort admission and random selection? Who collects this additional data? What resources are needed, for example for diagnostic interviews random pre-selection? How does a CONSORT diagram work for cmRCTs? Is the cmRCT cost justified in terms of cost per participant recruited in depression trials?

12. Sarah Ross, Project Manager sarah.ross@exeter.ac.uksarah.ross@exeter.ac.uk or Lucy Evans, Project Administrator l.evans@exeter.ac.uk http://www.exeter.ac.uk/mooddisorders/direct/