Wrap up of 2021

After a brilliant year of hard work and dedication, the SITU team has done some reflection on 2021, focusing on key events, trial progression, and more. Read on to discover how the year 2021 went for the SITU team...

Key Events:

• Congratulations to Professor David Beard who was awarded an Honorary Fellowship by the British Orthopaedic Association. Read the news story here.
• Professor Michael Douek has been elected Vice President of the British Association of Surgical Oncology BASO and will take on the role of President in two years‘ time.
• 'The challenge of equipoise in trials with a surgical and non-surgical comparison: a qualitative synthesis using metaethnography' was published. Congratulations to Loretta Davies and co-authors! Read the publication here.
• In March, the EndoNET trial received funding from the NIHR. Read about the EndoNET trial here.
• In April, Teya Agnese achieved a distinction in her Level 3 Business Administration Apprenticeship.
• Also in April, the NIHR funded the MelMarT-II trial. Read about the MelMarT-II trial here.
• The STIFF-F study paper was published: 'Reamed intramedullary nailing versus circular frame external fixation for segmental tibial fractures (STIFF-F): a mixed-methods feasibility study.' Read the paper here.
• New trials on the SITU NDS portfolio: SSF trial in transplantation has been funded and we have a few medical device trials in the pipeline for 2022.
• New trials on the SITU NDORMS portfolio: NIHR HS&DR project on Robotic Surgery evaluation and implementation has been funded and we have a VA Med Tech grant on the Plastics Portfolio - both grants to start in January 2022. 
• The Society of Clinical Trials (SCT) conference was held virtually on 17th - 20th May 2021. Professor David Beard (Professor of Musculoskeletal and surgical sciences, Rosetrees Royal College Surgeons [England] Director of SITU [NDORMS]) presented at the conference and members of the SITU team attended. Read about the SCT event here.
• Nadjat Medeghri ran an OCTRU training session on Trial Committees and Oversight, which again was well received, and has also been involved with some working groups.  
• Back in June, the SITU team took charge of the back pages of the Journal of Trauma and Orthopaedics (JTO) to discuss the key issues around placebo-controlled trials in surgery. Members of the SITU team who were involved in this publication include Professor David Beard, Shiraz Sabah, and Naomi Merritt. Read our blog post about the JTO article here.
• In July, members of the SITU team assisted with the NDORMS work experience which was held virtually again, and was a huge success! 
• The 6th annual Bristol Oxford Surgical Trials Course (BOSTiC) was held in Bristol this year at Engineers' House, University of Bristol. Excitingly, this was the first in-person conference that many of the attendees and faculty had been to since the advent of the COVID-19 pandemic. Read our blog post about the BOSTiC event here.
• The SITU team has welcomed 8 new Trial Managers and a Data Coordinator.

HOW HAVE OUR TRIALS PROGRESSED THIS YEAR?

 NDORMS Trials

PRoCuRe: It’s been a busy 12 months of study set-up for the PRoCuRe team; achievements include, OCTRU greenlight, pilot site activations, start of recruitment, and participant randomisations. The pandemic presents new challenges and we thank the staff at our recruiting centres for their tremendous (ongoing) efforts. With the planned end of the pilot phase insight, we look forward to 2022 and the next phase of the study.

PASHiOn: The PASHiOn study team has done a great job during the year to complete setup, open the study for recruitment and to complete phase 1 of the study. We are now looking forwards to moving into the main recruitment phase of the study next year. This will mean opening new sites in the new year with whom I am really looking forwards to working with to get the trial fully recruited and into follow-up.

NEON: NEON has now successfully reached the pilot targets set for the project thanks to the engagement and hard work of all the sites during these challenging times. We look forward to moving to the next phase of the study and welcoming more teams on board with this interesting study.

ORiF: Despite the ups and downs of the pandemic, ORiF has continued to recruit ever since we re-opened to recruitment in July 2020. To date, we have randomised 212 participants - roughly 40% of our recruitment target. Our focus in 2022 is to open more sites and to continue engaging with our existing ones. All credit goes to our amazing site teams for their hard work and perseverance.

CPinBOSS: Despite the wide-ranging impacts of the pandemic and a change in trial manager for the CPinBOSS study, the team have been doing a fantastic job of keeping things running smoothly over the last year. We’ve reached the midway point of our recruitment target, with huge thanks owed to the continued effort and support of our recruitment sites. As the new clinical trial manager, I look forward to working with the sites in 2022, as the recruitment end date approaches and we enter the next phase of the study.

ACL SNNAP: It has been a busy year for ACL SNNAP with follow-up completed towards the end of November 2021, data cleaning and then analysis. We look forward to the results in the new year and plans are in place for write up and dissemination. 

TOPKAT: TOPKAT continues with the 10-year extended follow-up and readmission checks with sites. The plan is for this trial to be completed in 2023.

SPAARK: The SPAARK team completed the analysis and submitted the final report to the Funder this year, which is great news. The trial publication has been submitted and further updates on this will be circulated as they become available.

NDS Trials

EndoNET: This Trial is currently in set up. The Grant started in June 2021.

DISCUS: Greenlight was awarded and then we recruited our 1^st patient 12 hours later!

MELMART-II: An international trial looking at melanoma treatment has opened.

PART: PART has received all approvals.

PROMOTE: We held the SIV recently for Stage II and are currently awaiting approvals from the MHRA and HRA.

TRANSLATE: ‘Green light’ has been awarded and Oxford opened as a site on the 29^th Nov!

Future-GB: FUTURE-GB has opened 13 sites to recruitment and 8 of those have now progressed through the Stage 1 standardisation phase and into Stage 2, the full RCT. We’ve set up our Associate PI scheme, held an Investigator meeting for all sites, open or in set up. We have 25 sites in set up, which is significantly more than the initial 15 predicted on trial initiation. We have established good dataflow and communications with our recruiting sites and have a number of sites that will open early in the New Year. We are running approximately 6 months behind the predicted schedule, but have been working closely with the Funder (NIHR EME) and our TSC to implement processes that will allow sites to progress into Stage 2 at an earlier point, without compromising data quality.

MACRO: We have been awarded a 2 year funded extension and our 200^th patient has been recruited!

REFLECTIONS FROM THE SITU TEAM

Amy Taylor: This year, I have been mostly working from home, with occasional trips into the office. Notably, I was finally able to meet many of my new SITU colleagues at Lucy P’s leaving lunch – it was wonderful to get together and celebrate at the Butcher’s Arms like old times! I have been lucky enough to undertake a number of training courses this year, notably the MedDRA coding sessions, and I was able to attend the UKTMN annual conference, held online. This year, with the support of Nadjat, my Operational Lead, I have started a Level 3 Apprenticeship in Management, actioning items from my PDR to progress my skills. I consider myself very lucky to be able to take advantage of these opportunities and certainly could not do so without the support of my manager, and the wider team – who are a wonderful resource for hints, tips, laughs and a great place to vent when needed.

Lucy Davies went on maternity leave and had a baby boy in September!

David Smith: Personally, I’m enjoying being back in NDORMS and working on a new challenge – that being a device trial. I do look back on my year with great pride, having been involved with testing of the Oxford/AstraZeneca COVID vaccine, learning a lot about trial management and being part of some outstanding teamwork in the process. The highlight just has to be my share of the GQ Magazine Man of the Year award, even beyond all the papers in Nature Medicine and the Lancet!