Case study: Restarting Research - The C-STICH Study

Mr Phil Toozs-Hobson, Chief Investigator C-STICH (pictured); Max Hughes, Senior Trial Manager C-STICH, Birmingham Clinical Trials Unit; Dr Katie Morris, CRSL RH&C West Midlands, Deputy Director Birmingham Clinical Trials Unit write: 

In recognition of the burden on the NHS of coronavirus nationally, all non COVID-19 research was suspended. For C-STICH this day was Thursday 26 March 2020. Whilst COVID studies were a priority, it soon became apparent that the impact was not all-encompassing and as such our focus quickly turned to restarting recruitment at those Trusts who felt able to do so.

C-STICH was the ideal study to restart. It is a trial comparing two treatments in women at risk of preterm birth or miscarriage, which were still essential during the pandemic, and women continued to receive treatment outside of the trial. Crucially C-STICH required no additional hospital visits; participation presented no more risk to the participant than normal care.

Following a risk assessment, C-STICH was officially reopened on 5 May. Guidance was drafted on how C-STICH activities should be prioritised, devolving the actual decision to the 70+ centres at a local level, recognising the varying and limited research capacities of many Trusts who were asked to grade their local capacity levels.

Pre-COVID our average monthly recruitment was 37 participants. Following the restart C-STICH recruited 13 participants in May and 27 in June with 50 per cent of units reopened by the end of June. Our emphasis was to focus on liaising with Research and Development (R&D) staff, Principal Investigators (PIs) and research nurses/midwives - letting them know how instrumental they are to the success of the trial, and the response was overwhelming.

A key strategy was a weekly recruitment restart videoconference, with all sites invited and the majority able to attend. This was supplemented by a C-STICH newsletter with a COVID-19 focus, which included a number of success stories from individual centres about the effect of the pandemic on local research activity. Also including reminders on capacity grading and a short justification for restarting recruitment of C-STICH that a PI or research nurse/midwife could copy and paste into correspondence with their R&D office, to help local decision making.

Units fed back that R&D offices were occasionally slow to confirm recruitment could restart , sometimes due to capacity issues within local research teams, but also to the sheer volume of trial assessments they were having to make, and so concise and clear wording to support R&D offices in decision making was felt crucial. A Twitter presence was also a useful tactic in communications.

By maintaining communication with Trusts, and providing helpful guidance, we have quickly re-established recruitment rates to near pre-COVID levels. C-STICH is blessed with some excellent collaborators, with hard working, dedicated and passionate R&D staff, PIs and research nurses/midwives who have ensured C-STICH will be successful, despite the pandemic. Once again a massive thank you to all involved for your passion to deliver this study.

Further reading: East Lancashire team makes flying restart on reproductive health study