VROOM is one of the newest clinical trials to be started by OCTRU. It has been getting lots of attention in the media, so we asked the Clinical Trial Manager, Lucy Cureton, to tell us a bit more about it.
There is great enthusiasm about this study, especially from our sites (the NHS hospitals recruiting patients) and participants, so it has been fantastic to see VROOM in the media. Following the BBC new article and radio interview with Professor Abhishek (VROOM Chief Investigator), we received many enquiries from people wanting to join the study– our Freephone number was ringing off the hook and the inbox was overflowing! As you may have seen recently, the VROOM study, run by OCTRU, has been in the news.
To get a study open and recruiting - especially a study like VROOM, which is urgent, fast-paced and involves a lot of manual input from the trial management team - a lot goes on ‘behind the scenes’.
What is VROOM?
VROOM (Vaccine Response On/Off Methotrexate) is recruiting patients who take methotrexate. The aim is to determine whether temporarily suspending methotrexate treatment for two weeks enhances the Covid-19 vaccine response. People taking methotrexate have compromised immune systems, so they receive their Covid vaccinations earlier than the general population. To take part in the study, patients must not have had their 3rd dose or booster yet. The booster program has been rolled out at speed, so VROOM has had to keep up!
There is always a time pressure when setting up a study, but VROOM takes it to the next level. With every day that passes, it is more likely that patients will have received their boosters, making them ineligible to take part.
As the vaccines are not being given as part of the study, the booster program is not something that the VROOM team has any control over. Last minute adjustments have had to be made following unexpected announcements from the government. The day before opening to recruitment, there was an announcement made advising patients to get their ‘3rd prime dose’ of the vaccine – we had to very quickly submit an amendment to Ethics as throughout the the protocol and the patient-facing documents we had only referred to the vaccinations as ‘boosters’, which could have been confusing to the patients. Running a Covid trial is like taking a step into the unknown - it is difficult to plan for something that is so unpredictable.
Potentially eligible participants are sent a recruitment pack through the post, inviting them to join the study. Each recruitment pack contains a Trust-specific letter & reply slip, a Patient Information Sheet and a Freepost envelope. The packs are printed and assembled by hand by the trials team based at the Botnar Research Centre. So far, the trial team has sent out around 3500 recruitment packs. A lot of stationary is needed to keep up the assembly line of recruitment packs. Requests for more recruitment packs come in from sites all the time. Boxes and boxes of envelopes, labels, paper, and jiffy bags have almost become part of the furniture.
Participants in the study consent to being contacted by the trial team to remind them of their allocation, ask for information about their vaccine and collect outcome measures. Whilst the majority of correspondence is automated via SMS text messages and emails, some participants ask us to post the questionnaires or to telephone them with reminders. We have different processes in place to track which patients we need to telephone or post questionnaires to; planning and co-ordination is required to make sure that all participants are contacted appropriately and on time.
The trials team has been mentioned several times in this blog. ‘Team’ may give the image of a whole office of happy helpers, but in reality the team is comprised of myself, Lucy Cureton, as Trial Manager, and Becky Maclean as our Clinical Trial Administrator. We are greatly supported by our Operational Lead (Anne Francis) and OCTRU Hub manager Vicki Barber, who are always happy to get involved with any of the manual tasks.
Setting up a study goes far beyond the trials team, though; OCTRU and other teams within NDORMS support us with many different activities and contribute considerably throughout the lifetime of a trial. Our OCTRU programmers turned the database build around in record time, taking an ‘all hands on deck’ approach to get things done as soon as possible, patiently dealing with any hurdles that came up. The finance team helped us the study grant and with ordering the many consumables needed for VROOM, recognising the urgency and appreciating that we didn’t always have the correct codes for things! IT helped us with setting up iPads for the sites, a Freephone number for the patients to call us on and with plenty of the challenges that come with working remotely. Thank you to all for their contributions.
To date, VROOM has recruited 190 participants, with a further 150 having registered their interest. Keep up to date with our progress here: https://vroom.octru.ox.ac.uk/
Clinical Trial Manager, OCTRU.