South Gloucestershire Medical Research Unit
to run your Research Trial?
Experience and Performance
We have met our targets in 90% of all commercial trials completed so far and exceeded recruitment targets in over half of completed trials we have been involved with, often significantly so (for example, we recruited 70 patients to a COPD study with a target of 12).
We have experience of working with GSK, Leo Pharma, Quintilles/Iqvia, Urgo, PRAHS, PPD, MSD, Enteromed, FirstKind, Novartis, Amgen, Shionogi, Chiesi, Smith and Nephew, Bayer, and others.
Experience with commercial companies has included studies in COPD (targets met/exceeded), Asthma (target exceeded), several Chronic Cough studies (target exceeded), Psoriasis (target exceeded), acute gastroenteritis (target exceeded), Flu vaccine safety studies (target met), Irritable Bowel Syndrome (target exceeded), Chronic Leg Ulcer dressings (target met), lipid lowering treatment in patients at risk of cardiovascular disease (target exceeded), and Type 2 Diabetes (target met).
We have also been highly successful with recruitment to a number of academic observational and interventional trials:
We recruited over 360 patients to the CANDID study (bowel/lung cancer) and were consistently the top recruiter in the South West area each month. We exceeded our target in the interventional PANDA and ANTLER (antidepressant RCTs) trials, recruiting 33 patients for PANDA and being the top recruiting practice in the country for this study. We also excelled in our recruitment for the interventional Asthma FAST trial, recruiting 18 patients and were named the top recruiting centre in the South West at the start of this trial. We recruited 26 patients to TIMELi, a dementia study, and 55 patients to HEAT (aspirin and H. pylori study). We were also very successful in recruiting for the interventional trials BARACK-D (Trial of spironolactone in Chronic Kidney Disease; 23 randomised– second best in the country) and TASMINH4 (Home BP monitoring study: 13 randomised).
Recent academic research studies have included a wide range of diagnoses – in addition to those mentioned above, we have taken part in studies in the following population groups: childhood acute cough/LRTI, childhood flu in at risk patients, Hepatitis C, childhood ear pain, antihypertensive therapy in the elderly, childhood eczema, low back pain, acne, anxiety, near-patient testing for respiratory pathogens, colorectal cancer diagnostic testing, use of Electronic Risk Assessment Tools, structured medication reviews, male Lower Urinary Tract Symptoms, antidepressant trials and COVID-19 treatment/prevention and surveillance trials.
Depending on the study, recruits can be identified using an alert on the electronic medical record, which will prompt opportunistic recruitment when patients are seen or telephone-triaged by the surgery. With most GPs being GCP trained and experienced at recruiting to research studies, recruitment is part of our daily routine.
We have over 600 patient consultations per week at our surgery amongst our GPs alone.
We are highly skilled at developing detailed database searches to rapidly highlight potentially eligible patients using key features from the protocol inclusion/exclusion criteria.
The Research GP and/or nurse is also able to contact patients by telephone to discuss the opportunity to take part in the trial – a strategy that has been very successful with previous studies.
Studies are advertised to patients on our notice board, on our website, and in our newsletter, and also mentioned when patients attend their annual medication review check-ups where appropriate. Any Sponsor-provided advertising material is proudly displayed in our waiting room and online.
Regular Research-focused team meetings help ensure the whole team is aware of active studies, which helps drive our recruitment, and we strive to recruit patients rapidly and always aim to be the first site to recruit in the UK.
We have a good relationship with large local General Practice Surgeries, which we often work with as PIC sites, increasing our patient pool. We also have several local pharmacies, willing to refer us patients directly, if the Sponsor would consider utilising this approach as well. We are continuously looking to increase our PIC sites and also work with Secondary Care Hospital Trusts, who refer patients to us when more specialist patient conditions are being investigated.
We have found our patient population very interested and keen to participate in research studies and have been innovative in our approach to recruiting patients, establishing protocols on EMIS Web which trigger alerts and self-populate basic details in research paperwork, saving time and easing the recruitment process.
Our retention rate has been very high with over 90% of patients completing a study that they start.
Facilities and Resources
We are an experienced team with a dedicated Clinical Trials Unit on site. We have a spacious purpose-built modern building which lends itself perfectly to research projects and can easily accommodate space to recruit patients. This has an examination couch, centrifuge and -20 and -80oC freezers, and is large enough to house trial specific equipment. We also have on site spirometers, ECG machines, venepuncture equipment, and refrigerators. All our equipment is calibrated at least annually. We temperature-monitor drug storage cabinets Monday-Friday with min/max thermometer checks.
We are experienced at using refrigerated centrifuges, cold chain supply management, drug storage and dispensing.
Our dedicated Research Team consists of a GP, 2 specialist research nurses and a research administrator, who would be responsible for facilitating the study in the Unit. They are available to enter study data into the data collection portal on the day of the study visit over 95% of the time. We also have an on-site Pharmacist available for medication related research activities.
Our research GP won the national RCGP/NIHR Award for research excellence, awarded at the RCGP Annual conference in October 2016.
6 of our surgery doctors are GCP trained, and experienced Sub-Investigators, as well as several practice nurses (in addition to the research nurses).
We are highly experienced at site setup processes and are able to fulfil set up requirements quickly. The research GP, together with supporting administrator, is available to complete local setup for studies, and the administrator and research nurse are available to complete the study’s data entry.
We pride ourselves in our rapid response to queries, throughout trial set-up and beyond, with nearly all emails answered within 1 day. We have a single point of contact for study staff to contact us and a Commercial Trials Manager available to answer any queries promptly.
Set up would be a matter of weeks due to the good relationships established with the R&D governance teams in our CCG and network area.
We use the ABPI model contract and standard industry costing templates.
Our wide ranging experience with Electronic Data Capture and online research support portals includes: Inform, RAVE, RDC, Castor, Sealed Envelope, RAMOS, Oracle IRT, CPAC, Suvoda, Research Online, Open Clinica, Edge, and Exostar; and we have had experience of collaborating with many study vendors including: Vitalograph, PPD labs, ERT, Propeller Health and iCardiac, amongst others.
SGMRU is part of South Gloucestershire Medical Services Ltd. Registered Office: 3 Church Lane, Coalpit Heath, Bristol, BS36 2SR, England UK. Registered in England and Wales No. 11335141