International Clinical Trials Day 2021

International Clinical Trials Day (ICTD) is celebrated annually on or around 20 May to recognise the day in 1747 that James Lind carried out what is often considered the first randomised trial.

This year the National Institute for Health Research (NIHR) is celebrating ICTD over an extended period in light of the vital role research has had with identifying treatments and vaccines during the Covid-19 pandemic.

ICTD isn’t just about celebrating with the staff involved; we need to thank the patients and public who consent to take part. Over the next four weeks we hope to be able to bring you information around Clinical Trials Day, our teams and the different types of trials taking place around the Trust including our recent participation with urgent public health studies for Covid treatments.

You can read about it in the section below titled Clinical Trials Day 2021.

We are on Twitter, @BHRUT_Research, should you wish to follow us to keep up to date.

The Trust also has a Facebook page you can follow to keep up to date on all the happenings around our hospitals.

Patient story

On Clinical Trials Day 2019, our Trust’s Communications team interviewed one of our previous Patient Research Champions, Helen. Below is the article from the Trust newsletter following the interview:

It was International Clinical Trials Day (Tuesday 21 May), and our Research and Innovation team was working hard to raise awareness of the work they do, hosting a stall in the atrium at Queen’s Hospital. They were lucky to also have on hand one of their biggest champions, Helen Heagren (pictured), who has been on a clinical trial since she was diagnosed with stage four ovarian cancer in 2016.

The 54-year-old told us a little more about why she’s so passionate about spreading the word on the research that takes place in our Trust:

“I knew nothing about clinical trials before I was diagnosed. I decided it was the right thing for me, mainly because I would have given anything a go at that stage.

I had the drug Avastin in my chemotherapy and it helped to shrink my tumour. I haven’t had any treatment for 18 months; however, at my last scan the tumour had grown slightly so I’m being monitored more closely at the moment.

I’ve been really well looked after. I even nominated my clinical trials nurse, Tina Mills-Baldock, for a hero award as she’s been so brilliant, and she won! She just gets me.

The most important thing for me about my trial is that it’s given me hope. I think it’s imperative that research happens, our lives are worth it.

Now I do everything I can to share my experience and encourage others. My cancer is incurable but it doesn’t stop me doing anything – I don’t plan on going anywhere anytime soon.”

We are now entering the third week of the International Clinical Trials Day campaign for 2021. This week we are sharing information around the education and training needs within research and why this is important for those who participate.

The Principle Investigator (person leading the research project locally at sites) has to be satisfied that the staff being delegated study related tasks are appropriately trained and experienced to do so. This is to ensure the safety of patients on the trial and the quality of the care they receive. 

To support our Principle Investigators with this role, we deliver training in the oversight they need to provide to their different projects to ensure these are run safely and in accordance with the relevant governance and legal frameworks.

For some study types, i.e. a clinical trial of an investigational medicinal product (CTIMP), it is a legal requirement for study staff to be trained in Good Clinical Practice (GCP). GCP is an internationally recognised standard which exists to ensure patient safeguarding and the protection of their rights and wellbeing when taking part in a trial. This training has to be refreshed every two to three years. At BHRUT, we ask that all our staff, whether or not they are working on a CTIMP, do this GCP training and ensure this is regularly updated.

We also deliver training in receiving consent for research. This training ensures our staff understand the ethical principles when recruiting patients and examples good and bad practices of receiving consent so when patients are approached to take part in any of our studies, these are explained in such a way that they are able to make an informed decision on whether or not to take part, free of any coercion. 

The materials for all of these courses and the training of our staff who facilitate these is provided by the National Institute of Health Research which allows us to run these internally on a flexible basis so we can ensure our staff can access training at convenient times without impacting on the clinical care they are providing on a day-to-day basis.

Practical studies

The Covid-19 pandemic necessitated that research into potential therapies occurred in parallel to the outbreak and, indeed, was part of the treatment options offered to patients. The national research strategy prioritised Covid-19 research and such studies were badged as Urgent Public Health (UPH) research. Every hospital in England was encouraged to participate in these studies.

One of the biggest of these UPH trials we are participating in is the RECOVERY Trial. This trial evaluated potential emerging therapies that had shown some signs of improving outcomes for patients hospitalised with Covid-19 but needed to be fully assessed in randomised controlled trials to fully ascertain whether there was benefit from their use.

Patients with Covid-19 in our Trust were approached and offered the chance to take part in the trial as it offered them participation in research and access to therapies being evaluated, but also enabled them to help others.

Since the opening of this study at our trust, we have recruited 328 patients to this trial. We are proud to say that we and our patients have taken part in this study and have contributed to discovering treatments such as Dexamethasone and Tocilizumab, which have been proven to save lives. We have also contributed to data that has ruled out futile treatments for Covid-19 such as lopinivir/ritonivir, hydroxychloroquine, colchicine and convalescent plasma. Without this latter research, patients would have continued to be given drugs that carry side effects and do not improve patient outcome.

Some hospitalised patients went on to develop severe Covid-19 and were admitted to intensive care. At this point, these patients were offered the chance to additionally participate in another trial called REMAP-CAP which was aiming to identify therapies specific to those who were critically unwell with Covid-19. Patients were eligible to take part within 24 hours of admission to the intensive care (some ward patients were also eligible for certain aspects of the trial) and were able to have access to multiple therapies being evaluated including steroids, convalescent plasma, blood thinners, and immunotherapy.

The trial looked at how drugs worked in combination and the nature of the trial was such that patients were most likely to be allocated a treatment in the trial that was showing a signal towards benefit. We are proud to have participated in this trial as it has been pivotal to providing evidence for the use of Tocilizumab and therapeutic dose blood thinners in certain subsets of Covid-19 patients. Our recruitment to this trial to date is 19 patients.

We continue to offer the RECOVERY and REMAP-CAP trials to our patients and remain at the forefront with the national effort to discover therapies for Covid-19. Vaccination research is needed to prevent the illness from occurring, but therapies and a better understanding of the disease are needed to help those who go on to develop the illness despite the national vaccination effort.

We must of course thank our principal investigator, Mandeep Phull as well as her research team, and must also pay thanks to the patients who participated and the wonderful ward staff who have been very accommodating and helpful in assisting in the delivery of this research throughout the pandemic.

 

Observational studies

As well as practical studies, there are also studies that are more observation based, looking through medical history of a patient’s time in hospital, to measure a variety of different things. One Urgent Public Health observational clinical study we have been recently assigned to is known as ISARIC. As it is a matter of Urgent Public Health, patients are not selected for recruitment. In fact, we are required to collect the data from each individual admitted to the hospital who meets the required criteria. To date, we have recorded approximately 2,447 individual admissions to this survey. This number does not reflect the total number of patients admitted to our trust with Covid-19, as patients who have left the hospital but are readmitted at a later date also have the second instance recorded.

The summary of this trial, following the document changes to allow for Covid-19 research on 24/02/2020, reads as follows:

“New infectious agents, such as the SARS coronavirus, new strains of influenza, and HIV, continually appear and require new investigations to understand how the disease works and how it interacts with the person infected. There is an urgent need to conduct coordinated clinical research relating to the Covid-19 outbreak to learn more about the virus and to provide evidence to help decide treatments and to ensure an effective public health response.

"This study will provide rapid, coordinated clinical investigation of patients with confirmed Covid-19 infection. It will look at how the virus reproduces and is excreted by the body, how the body responds to infection and treatment over time and how the immune system responds. The study has been designed to ensure that as much data as possible is collected and shared rapidly in a format that can be easily added together, tabulated and analysed across many different settings globally. It is designed to be flexible to ensure the best acceptance by health care organisations.”

For further information about this trial, head to the ISARIC website.

 

*Please note – information is accurate at time of recording, May 2021*

If you wish to join a research study currently open at our Trust, you must first be under the care of this hospital. You should discuss your wishes to be involved in research with your doctor or clinical team as there are strict criteria for each research study and some studies may be more appropriate for you than others. The decision to participate in a research study remains yours, but you may wish to discuss your participation with your family, friends and/or GP.

BHRUT Research Performance - OPE

NIHR ID	Project Full title	Site status	Main Speciality	BHRUT Division
10416	The UK Multiple Sclerosis Register	Open	Neurological Disorders
17199	Immediate coronary angiography after out of hospital cardiac arrest (ARREST)	Open	Cardiovascular Disease	Acute Medicine
43094	Clinical Educators in Emergency Departments - CEED	Open	Trauma and Emergency Care	Acute Medicine
32889	Optimisation of Peri-operative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) Trial: Open, multi-centre, randomised controlled trial of cardiac output-guided fluid therapy with low dose inotrope infusion compared to usual care in patients undergoing major elective gastrointestinal surgery.	Open	Anaesthesia, Perioperative Medicine and Pain Management	Anaesthetics
33869	FLO-ELA	Reviewing Suspension - Covid 19	Anaesthesia, Perioperative Medicine and Pain Management	Anaesthetics
43238	Critical illness related cardiac arrest (CIRCA)	Open	Critical Care	Anaesthetics
34023	Canadian Institutes of Health Research	Open	> Critical Care	Anaesthetics
N/A	UNITE-COVID-19	Open	Critical Care	Anaesthetics
38197	Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia	Open	Critical Care	Anaesthetics
30540	Genetics of susceptibility and mortality in critical care (GenOMICC)	Open	Critical Care	Anaesthetics
37390	BLING III study	Set up on hold - Covid 19	Critical Care	Anaesthetics
18218	AML 19: Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome	Suspended	Cancer	Cancer
1409	STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy	Open	Cancer	Cancer and CSS
16675	FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab	Open	Cancer	Cancer and CSS
15938	AML 18: A Trial for Older Patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome	Open	Cancer	Cancer and CSS
36735	SUMMIT: Lung cancer screening study using low dose CT to support the development of blood tests for early cancer detection	Open	Cancer	Cancer and CSS
40503	Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Matching Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD- L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD- L1 Expression (LEAP-011)	Open	Cancer	Cancer and CSS
18137	PARADIGM OlaPArib And RADiotherapy In newly-diagnosed GlioblastoMa:	Reviewing Suspension - Covid 19	Cancer	Cancer and CSS
30967	ROAM	Recruitment on Hold - Covid 19	Cancer	Cancer and CSS
20443	TRACC - Tracking mutations in cell free tumour DNA to predict Relapse in Early Colorectal Cancer	Open	Cancer	Cancer and CSS
42281	Myeloma XIV (FiTNEss)	Set up on hold - Covid 19	Cancer	Cancer and CSS
42313	MONITOR	Set up on hold - Covid 19	Cancer	Cancer and CSS
44365	THE SOCIAL CONSEQUENCES OF NEW TECHNOLOGIES IN BRAIN TUMOURS	Set up on hold - Covid 19	Cancer	Cancer and CSS
34487	Systematic Genetic Testing For Personalised Ovarian Cancer Therapy (SIGNPOST)	Open	Cancer	Cancer and CSS
15909	Mesothelioma and Radical Surgery 2: a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma (MARS 2)	Open	Cancer	Cancer and CSS
18621	Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer	Open	Cancer	Cancer and CSS
30433	Randomised, phase II/III, 3 stage trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in breast cancer patients with TNBC and/or gBRCA	Open	Cancer	Cancer and CSS
34473	A Cohort Study To Establish the Prevalence of Mutations in Patients with CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ALL With Detectable BCR-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing	Open	Cancer	Cancer and CSS
39645	Quality of Life After Bladder Cancer (Q-ABC): A comparison of patient related outcomes following radical surgery and radiotherapy	Open	Cancer	Cancer and CSS
40432	A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers	Open	Cancer	Cancer and CSS
41941	Randomised phase II/III study of Rituximab and Ibrutinib (RI) versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as initial therapy for Waldenström's macroglobulinaemia	Open	Cancer	Cancer and CSS
869	UK Genetic Prostate Cancer Study	Open	Cancer	Cancer and CSS
1471	Radiogenomics: assessment of polymorphisms for predicting the effects of radiotherapy	Open	Cancer	Cancer and CSS
9812	ICON8 and ICON8B - ICON8 Trial Programme (as per protocol v5 dated 17/12/2014)	Open	Cancer	Cancer and CSS
10357	Leukaemia Lymphoma Research and NCRI Working Group Pick a Winner Programme (LI1) Trial	Open	Cancer	Cancer and CSS
12255	Optimal Personalised Treatment of early breast cancer using Multiparameter Analysis	Open	Cancer	Cancer and CSS
4961	United Kingdom Adult Idiopathic Thrombocytopenic Purpura (ITP) Registry: An Investigation of Disease Progression, Treatment Effectiveness, and Co-morbid Conditions	Recruitment on Hold - Covid 19	Haematology	Cancer and CSS
37452	INSPIRE	Suspended	Neurological Disorders	Cancer and CSS
N/A	Neurological Complications Associated with Coronavirus Disease-2019 (COVID-19) Virus: MRI and CT Features	Open	Neurological Disorders	Cancer and CSS
40554	RIvaroxaban for Stroke patients with AntiPhospholipid Syndrome	Set up on hold - Covid 19	Non Malignant Haematology	Cancer and CSS
31694	Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer (NeoART trial)	Suspended	Surgery	Cancer and CSS
N/A	Occupational Stress of Health Care Professionals at BHRUT during the Covid-19 Pandemic	Open	Mental Health	Corporate
31185	NOAH-AFNET 6: Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes	Reviewing Suspension - Covid 19	Cardiovascular Disease	Specialist Medicine
17302	PROgressive Supranuclear Palsy CorTicoBasal Syndrome Mulitple System Atrophy Longitudinal Study UK (PROSPECTMUK)	Reviewing Suspension - Covid 19	Dementias and Neurodegeneration	Specialist Medicine
18437	Parkinson's Families Project (PFP)	Open	Dementias and Neurodegeneration	Specialist Medicine
40906	CHIEF-PD STUDY	Recruitment on Hold - Covid 19	Dementias and Neurodegeneration	Specialist Medicine
19837	DexEnceph: A pragmatic, randomised, controlled, observer­blind trial comparing clinical outcomes in adults who receive  dexamethasone alongside standard treatment versus standard  treatment alone for Herpes Simplex Virus encephalitis.	Open	Infection	Specialist Medicine
45388	Randomised Evaluation of COVID-19 Therapy (RECOVERY)	Open	Infection	Specialist Medicine
14152	ISARIC: Clinical Characterisation Protocol for Severe Emerging Infection	Open	Infection	Specialist Medicine
35831	MS-STAT2	Recruitment on Hold - Covid 19	Neurological Disorders	Specialist Medicine
37685	The EMPA-KIDNEY Study	Reviewing Suspension - Covid 19	Renal	Specialist Medicine
6726	National Studies of Rare Kidney Diseases	Recruitment on Hold - Covid 19	Renal	Specialist Medicine
37304	RETAKE - Return to Work After Stroke	Reviewing Suspension - Covid 19	Stroke	Specialist Medicine
33908	SALIVA TO PREDICT DISEASE RISK (version 1)	Recruitment on Hold - Covid 19	Cancer	Surgery
20664	IBD Bioresource	Recruitment on Hold - Covid 19	Gastroenterology	Surgery
43521	EAGLE: ESCP sAfe-anastomosis proGramme in colorectaL surgEry	Reviewing Suspension - Covid 19	Surgery	Surgery
35821	UK Cohort study to Investigate the prevention of Parastomal Hernia	Suspended	Surgery	Surgery
45676	Neonatal Complications of Coronavirus Disease (COVID-19) Study	Open	Children	Women and Child Health
34058	Linagliptin and empagliflozin in children and adolescents (DINAMO)	Suspended	Children	Women and Child Health
39733	PReCePT Study – A cluster randomised trial evaluating the impact of an enhanced support implementation of the PReCePT quality improvement toolkit to increase the uptake of magnesium sulphate in pre-term deliveries for the prevention of neurodisabilities	Open	Reproductive Health and Childbirth	Women and Child Health
	Creating positive working and learning environments utilising the Formative Change Laboratory in Obstetrics and Gynaecology	Open	Reproductive Health and Childbirth	Women and Child Health
39971	The POOL study	Open	Reproductive Health and Childbirth	Women and Child Health
5774	Continuation of SAFE (Incorporating RAPID)	Open	Reproductive Health and Childbirth	Women and Child Health
14162	Maternal and Perinatal Outcomes of Pandemic Influenza in Pregnancy	Open	Reproductive Health and Childbirth	Women and Child Health
20626	GEM3: A double blind placebo controlled trial of a combination of methotrexate and gefitinib versus methotrexate alone as a treatment for ectopic pregnancy	Open	Reproductive Health and Childbirth	Women and Child Health
14362	The Cleft Collective Cohort Studies	Open	Reproductive Health and Childbirth	Women and Child Health
18346	The Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes (C-STICH)	Recruitment on Hold - Covid 19	Reproductive Health and Childbirth	Women and Child Health

Download Internet Trials List 13.08.20 [xlsx] 19KB

To search for Clinical Research Studies nationwide, please use the NIHR’s search below. Please be advised, all clinical research studies have an inclusion/exclusion criteria to ensure patient safety. There may be trials that you feel you could be suitable for but please speak with your nurse or doctor, who will be able to advise you further.

Patients and the public are at the heart of everything we do, and who would be better to describe the experience of participating in research than those who have taken part in a study themselves?

What is a research champion?

Research Champions volunteer their time to help spread the word about health and care research to patients and the public, and to help promote across those groups who are currently less likely to take part in research. They also help research and healthcare staff understand more about the experiences of those who take part in research.

Anybody can be a Research Champion; you don’t have to have participated in a research study before. Watch below as Dr. William van’t Hoff, Clinical Director for NHS Engagement, talks about the initiative.

Find out more information about the roles of the NIHR Research Champion and how to take part.

Alternatively, contact Ben Sartoris, ben.sartoris@nhs.net for further information.

Please follow the link below to see our performance in initiating and delivering on clinical research trials:

https://ccfctp.nihr.ac.uk/public-trustsubmissions/barking-havering-and-redbridge-university-hospitals-nhs-trust-1042

Our research team works over a number of different clinical areas. If you have a question or want to discuss about a certain clinical specialty, please contact the Research and Innovation Department either on: 01708 435 000 ext. 3711 or email our generic mail box: bhrut.research.development@nhs.net

To read about some of our research team, who participated in our Trust’s ‘In Conversation With...’, please view the links below to read the articles.

• Sam King
• Laura Parker
• Nik Haliasos