KEY EVENTS THAT have HAPPENED IN SITU...
- In March 2019, we all started working from home; This involved adapting to using Microsoft Teams as our main method of communication. Read all about how our team felt about this adaptation in the blog post: 'The Truth About Microsoft Teams: Part 1.'
- Teya managed to scoop up not one... not two... but THREE awards this year, taking home the University of Oxford 2nd Year Apprentice Award, the Oxfordshire Intermediate Apprentice Award and overall Oxfordshire Apprentice of the Year 2020. She also came highly commended in the Regional Apprenticeship Awards 2020.
- The SITU work experience sessions were held virtually this year and despite this, they were a huge success! Find out more about how they went on the blog post: 'SITU Work Experience 2020.'
- We said goodbye to a few members of our team this year, and warmly welcomed our wonderful new members - Jack Morris, Naomi Merritt, Claire Thomson, Nadjat Medeghri, and Elsa Mauricio Reus.
- Amy Jones said goodbye to NDORMS and hello to NDS.
- Due to this years' circumstances, the SITU team decided to set up an online resources work group. The purpose of this group is to improve our communication between trials units and sites, our resources to help us to support the research nurses on site visits and with online training resources such as training videos.
from the SITU Team...
WHAT Are our TEAM are proud of doing this year?
Jo "I have learnt loads over the last few months especially. Before Claire T started as ProMOTE trial manager I was managing it in on an interim basis and have never managed a CTIMP before. There was a lot to learn and digest but the trial had finished stage 1 so recruitment had finished and prep was starting for stage 2. The lockdown gave me the opportunity to read everything properly and not rush. Going forward this will be invaluable and I don’t think I will be as worried about managing one in the future.
I have also spent time working with Lucy Davies on trial set up and protocol development with the CI’s on the DISCUS trial. Again I haven’t worked on a trial at this early stage before and it has been another great learning/development opportunity.
On a personal note I am making all my own xmas cards this year so am craft mad and have cleaned every room and cupboard in the house!"
Steve "I'm proud that I managed to find a healthy work/life balance during lockdown and that I was able to maintain a positive outlook. Having two young children at home whilst working a full-time job has its challenges, but I managed my time effectively and really enjoyed spending more time with my family."
Claire "I finally took up learning French after wanting to do it for years and never finding time – no excuse now! I also moved house twice this year and am pretty happy with the amount of junk this forced me to get rid of."
Amy "This year, I am mainly proud of myself for learning to listen to myself a little more. Not just in terms of my instincts for work things and what I’m capable of doing (did I mention that webinar?!) but also for learning a better balance of work/life and the confidence to listen to my inner voice. It’s tempting, and sometimes necessary, to work a little later, just get a jump on tomorrow’s tasks; just reply to that email; just finish that one thing. But I know it was something that was making me feel burnt-out, and a pressure I put on myself. So now I make sure I get up and move around a lot more, write my to-do lists long hand so it’s not more screen time, and makes me slow down. I still burn the midnight oil on occasion if needed, but know I can balance that out and have easier days too! Work smarter, not harder and all that!"
Lisa "It’s definitely been a tough year for everyone. To keep busy we decided to paint every room of our flat. It took us a while but we feel a great sense of achievement now that it’s finished. Now to think of the next DIY project…"
Elsa "I changed jobs and moved house, lots of great changes this year! Started learning Italian."
Ivy: "2020 has been a challenging year for everyone. On a personal/positive note – this year has forced me to slow down and appreciate being home more!"
What training courses have the team completed this year?
Jo "The OCTRU amendment session I attended was fab and I loved the virtual student intake weeks over the summer that SITU ran."
Steve "I attended a training session on submitting amendments. This was really useful because I had to submit two substantial amendments this year and the IRAS application form has changed."
Amy "I did a bunch of not very glamourous but important training online this year."
Training through University/POD:
- Challenging behaviour: Dealing with bullying and harassment in the workplace
- Managing people: key processes
- Implicit bias in the workplace
- Information Security and Data Privacy Awareness training course 2020/21
- Tackling race bias at work course
This was from the MRC (NHS Scotland wanted proof that someone on the trial had undertaken this course for their ethics process)
- MRC Research, GDPR and confidentiality training online course
Training held by OCTRU:
- OCTRU Training bite: REDCap Overview
- OCTRU Training Bite: REDCap Advanced
- OCTRU Training Bite: Trial Closure and Archiving
The SITU Trial Management Forum
The Trial Management Forum has been an extremely useful tool that has been thoughtfully set up by Amy Jones, to enable the Trial Managers within SITU to have a safe, virtual platform where they can ask questions and update each other on their trials.
Amy stated... "I’ve found this really valuable, a place where I often ask questions in fact. We’re all working in isolation and it’s very easy to feel overwhelmed by some of the tasks involved in running trials. We’re all missing that “photocopier chat” not just about Bakeoff, but also about the minutiae of work. Where you’d bump into someone and say “ooh, Amy, have you ever filled in X form?” or “do you know who I ask about Y process?” That stuff is invaluable, to us in trial management, but also a human – we’re inherently social creatures. Anyway, all this to say, I find it really helpful and reassuring to see others and to chat about our trials (and tribulations*) and see if we can help one another!"
*sorry not sorry
How have the team been finding the forum?
Jo "Thanks so much to Amy for setting this up – it’s been invaluable for information and support. It has helped me with a lot of queries – but then the whole SITU group have been great at being there to help out with trial issues and queries. Look forward to seeing you all in person at some point in 2021!"
Steve "It's a really useful resource, especially whilst working remotely."
Claire "After a two year break from the world of clinical trials, I’ve found the forum really helpful to hear about others’ experiences with new processes and systems, and a chance to ask those silly questions you feel you should already know the answer to, but don’t..."
Elsa "The forum is extremely helpful and the chats are very informative and FUN! It has been a good excuse to get to know the other trial managers since I am new and we are not going into the office."
HOW HAVE OUR TRIALS PROGRESSED THIS YEAR?
PENTAGONS: ‘’We opened then had to pause randomisation again as half of our sites are in the ‘high’ tiers of the UK pandemic tiers; so have suspended routine and elective work. We are still screening and hoping with the news of a vaccine and a Joint TSC/DSMC meeting scheduled in Jan we will have some positive news!"
DISCUS: "This is going well and we are hoping for sponsor submission prior to the xmas break. There were interviews today for a trial manager."
UK TAVI: "UK TAVI was in follow up prior to the pandemic and therefore the lockdown had only minor implications for the trial. Some sites had restricted capacity where research nurses had been redeployed, and this lead to some delays in conducting the annual telephone follow ups, but overall this had minimal impact on the trial."
MACRO: "Recruitment was paused at the beginning of the lockdown and it has proved difficult to re-open recruitment. MACRO is an ENT trial where patients can be randomised to an elective surgery arm. Due to elective surgeries and lengthening waiting lists it's been difficult for sites to find capacity to guarantee surgery within 6 weeks as per protocol. Outpatients clinics have been cancelled so potential participants have not attended hospitals and many research staff have been redeployed to work on more essential services. We are now in a position to open a number of sites and hopefully we'll see some recruitment by the end of this year."
PART: Emma Harper left in July, Claire Thomson was interim trial manager, and is now handing over to Elsa Mauricio Reus who joined SITU in late November.
- Claire says: "PART is not yet open to recruitment; COVID has added extra time to get radiology, contracts, information compliance, information security and sponsor review. Sponsor approval is still pending after a lot of work to make sure the trial is GDPR compliant in relation to the QRI and joint data controllership with Bristol which have now been addressed, and we hope to be opening our first hub sites in spring 2021."
- Elsa says: "I joined SITU in late November. Claire Thomson was the interim trial manager who kindly handed over the trial to me. As Claire already mentioned: PART is not yet open to recruitment; COVID has added extra time to get radiology, contracts, information compliance, information security and sponsor review. Sponsor approval is still pending but are hoping it will be granted before Christmas."
ProMOTE: "We have completed the stage 1 first in human trial data collection and analysis to establish optimal dose and timing of administration of IMP and are currently preparing an amendment to progress to stage 2; a 120 patient randomised controlled trial pending second OCTRU green light. We have requested a 12-month no cost extension to help mitigate Covid-19 related delays and are awaiting response from Cancer Research UK."
FUTURE-GB: "FUTURE-GB is in the final stages of set up, hoping to get green light for the first stage of the trial soon. We have about 15 interested centres and some very keen PIs, so I am confident we can make this a success. We’re working with some industry collaborators who provide equipment to sites for the trial and we just held our first webinar to speak to sites and allow them time to see how the trial will work for them, and to allow them to ask questions of us, and the industry representatives.
Thankfully, FUTURE-GB was in setup when COVID hit, so it wasn’t immediately impacted, only by the knock-on effect of extended review times from REC and Sponsor as their priorities had to shift. We now face longer wait-times to get our industry-supplied kit, and to get Trust capacity and capability, but these times are reducing as processes change to accommodate this style of working."
PASHiOn: "My trial has been in set-up during the pandemic. This has had some implications on progress, such as delayed face-to-face surgeon training on the procedure, and the sites that have been identified as participating are understandably prioritising COVID-19 related / vaccine research. In light of this we have agreed to pause the grant until next year, and we are looking forward to restarting as soon as possible."
CPinBOSS: "CpinBOSS has been hit quite hard by COVID-19. As with all elective surgeries, all Single Event Multi-Level Surgeries (SEMLS) with the Cerebral Palsy cohort were put on hold, resulting in the service evaluation being paused between March and July. We re-started in July and opened NHS Trusts when they were able to continue non-COVID related research. We successfully applied for a no-cost extension resulting in an extended recruitment period. Recruitment is starting to build again and we have successfully opened 2 new sites over the past month."
PRoCuRe: "PRoCuRe was in the very early stages of set-up when COVID-19 started to make itself busy and we were instructed to ‘stay at home’ (‘protect the NHS’ and ‘save lives’). Despite the adjustments that came with working from home, everything continued according (pretty much) to the original time line for a good few weeks; CRFs were designed and our submission package for sponsor review came together nicely. It was at this point that COVID started to have a more of an impact as offices we were attempting to work with were, understandably, under a remit to prioritise COVID studies. Parallel to this, elective procedures were suspended across the NHS and it became clear that a recruitment start date of September 2020 would not be feasible; we established good lines of communication with our potential recruiting centres and allowed decision making to be informed by intelligence gained from our NHS colleagues. We have continued to progress with study set-up and hope to start recruitment spring 2021."
ORiF: "Due to COVID-19, the ORiF study temporarily halted to recruitment at the end of March. Thanks to the commitment and hard work of our sites, we started the process of re-opening in July. Recruitment has exceeded our expectations and in October, we had our best recruiting month to date."
NEON: "The NEON study is investigating how best to surgically manage digital nerve injuries (https://neon.octru.ox.ac.uk/). The study is open to recruitment in five NHS Trusts and has 4 participants randomised so far.
Like everything this year we have been impacted by COVID-19. We delayed recruitment from April until September, as resources were diverted to COVID-19 studies. We are now seeing fewer injuries than expected, likely a combination of lockdown leading to less risky behaviour and other conditions being prioritised.
SPAARK: "Luckily, SPAARK was not affected by Covid because the recruitment ended just before the pandemic began. The trial were over target with 533 patients recruited that was reached in February this year and the follow up period is due to end in February 2021. At the moment we are focusing on cleaning the data as much as we can in order to get into analysis stage. Overall, the trial is progressing very well."
STIFF and SPINOUT feasibility studies were completed this year. Final study reports are submitted, and the team are working on publications and study closeout.
It has been a busy year for NINJA with data cleaning, analysis and write up. The Oxford Finger Nail Appearance Score and the Health Economic and Statistical Analysis Plan (SHEAP) papers were published. The final study report is now submitted, and the team are working on publications and study closeout.
ACL SNNAP: "The ACL SNNAP trial very nearly reached its recruitment target with 316 of 320 patients recruited before recruitment was paused at sites due to COVID-19. Some of the patients in the trial who were yet to undergo their intervention have experienced delays in undergoing treatment as outpatient clinics and elective surgery lists were paused due to COVID-19. The trial protocol was published during the year. Follow-up will be completed towards the end of 2021 and the team will be busy with continued data cleaning, analysis and write up."
TOPKAT: "TOPKAT reached the start of the 10-year extended follow-up timepoint in January this year and plan for this to be completed in 2023…."
The team have also helped set up and are managing the REJOIN study (Restarting Elective Orthopaedic Joint Surgery after COVID-19). This multi-centre cohort study was set up earlier in the year as a collaboration between the British Association of Surgery of the Knee (BASK) and the British Hip Society (BHS) to help provide clinicians and patients vital feedback needed to support the restart of elective surgery.
Data management 2020 goals
Begin to move more trials towards remote data entry including the inputting of screening, training, delegation, and staff contact logs, as well as other key trial information.
We are/will be entering screening data onto the RedCap clinical database for all our new trials, with NEON as the trailblazer, following the success of ACL-SNNAP.
We are working on getting the other data entered directly onto a RedCap database, starting with the delegation log for NEON. The goal is to get rid of as much paper as possible.
Unleash the opportunities of REDCap, taking advantage of what the system has to offer;
We have worked closely with the OCTRU programmers to try and make our databases easier to use and to improve data quality.
Jamie has built a RedCap database from scratch for the REJOIN project, and CPinBOSS has been partially developed here in SITU, including incorporating e-consent by Aki. We have learnt a lot from doing this.
Create auto-reporting for TMG meetings;
This is ongoing – but we have used MS-ACCESS to automate as much as possible. We will be looking at possibly using R in the future.
Ensure processes are more uniform across the trials.
We have started on some data management guidance documents. We have one for testing databases, and intend to create more e.g. Database build process, remote data entry, removal of personal data – suggestions are welcome.
Goals for 2021:
- Put more trial management data onto RedCap, making it easier for sites to send standard data, so we don’t need to enter data manually.
- Work on standard processes across trials for using Redcap for data collection, making sure we sharing best practice and efficient processes.
- Increased automated reporting for TMG and Data Management meetings.
- Improve our online resources, to help sites.
- Build on our ability to develop ‘in-house’ RedCap databases, for small projects
- Learn from other units
situ team FESTIVITIES
Aimi's wreath from the NDS wreath making workshop.
SITU NDORMS Christmas virtual session. For context, Heidi treated us to a superb SITU Christmas song to the tune of 'Merry Christmas Everybody - Slade'. David is the back-up guitarist and Lisa is about to leave the Teams call.