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New med-tech partnership to assess quality of life in clinical trials and care

Written by Louise Stanley on . Posted in Clinical trials, Health inequalities.

BHP founder-member the University of Birmingham has today announced a partnership with med-tech company Aparito to co-develop digital platforms to assess patient quality of life and symptoms in clinical trials and routine NHS care.

The partnership will see the configuration of Aparito’s flagship software platform Atom5™, and brings together international experts in patient-reported outcomes (PROs) methodology and input from patients and clinicians, with cutting-edge and innovative technology.

The aim of the partnership is to co-develop multiple digital PROs for use in a wide range of disease groups to assess treatment safety and effectiveness from the patient perspective and enhance the patient experience of clinical trials and routine care. These data will support patient care and provide evidence to inform regulators and policy makers such as the Medicines and Healthcare products Regulatory Agency (MHRA), and the National Institute for Health and Care Excellence (NICE).

Professor Melanie Calvert, National Institute for Health Research (NIHR) Senior Investigator and Professor of Outcomes Methodology at the University of Birmingham’s Centre for Patient-Reported Outcomes Research (CPROR), said: “It is essential that we capture information on the impact of disease and treatment on patient symptoms and quality of life.

“This information can help regulators decide if a treatment is safe and effective and answer important questions from patients such as ‘how will it make me feel?’

“We are delighted to be partnering with Aparito to use cutting edge methodology and technology to advance this area and benefit patients.”

Dr Elin Haf Davies, CEO of Aparito, which is based in Wrexham in the UK and Leiden in the Netherlands, said: “We are highly honoured to enter into this partnership with the CPROR at the University of Birmingham.

“Professor Melanie Calvert and her team are highly regarded and international leaders in PRO methodology. We very much look forward to expanding on this work to provide a digitalised and personalised solution, in 2021 and beyond.”

One of the projects is the new National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre (NIHR SRMRC) ‘PRiORiTy’ (Patient Reported Outcomes Research in Trauma) study.

In this study, the team of experts at BHP founder-members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust will assess patient symptoms following traumatic brain injury to help tailor care to patient needs.

This is an important issue for patients, as explained b ypatient advocates involved in the design of the study, Luke and Jackie Flavell: “We feel it is really important for patients to report symptoms of traumatic brain injury as early as possible and doing this electronically would save valuable time and improve patient care. We are very much looking forward to working with CPROR on the PRiORiTy study.”

Daniel Lewi, Head of Business Development at Aparito, added: “Working with the team at University of Birmingham to provide a technology solution for PRiORiTy has highlighted how deeply clinicians care about the patient experience and how they can improve treatment within the patient cohort.

“Having such an approachable and knowledgeable team has allowed the University of Birmingham to detail very specifically how we can adapt our Aparito Atom5™ technology to really change a patient’s life and we cannot wait to work with the team again on future projects.”

Clinical trial confirms digoxin is effective for treatment of atrial fibrillation

Written by Louise Stanley on . Posted in Clinical trials, Inflammation and chronic disease.

A clinical trial has shown that digoxin has the same effect on physical wellbeing as beta-blockers when used to treat patients with permanent atrial fibrillation and symptoms of heart failure.

Beta-blockers have long been the drug of choice for controlling rapid heart rates in patients with atrial fibrillation (AF), but a clinical trial led by Professor Dipak Kotecha of Birmingham Health Partners has shown that digoxin is just as effective, but with less adverse effects.

The ‘Rate Control Therapy Evaluation in Permanent Atrial Fibrillation’ (RATE-AF) trial was the first of its kind to compare the effectiveness of digoxin and beta-blockers to treat AF. Beta-blockers, such as bisoprolol, are one of the most common groups of drugs used in clinical practice to reduce heart rate and improve pump function. Digoxin primarily works to slowly improve the contraction of the heart but also has other broad range effects which at low-dose can potentially be helpful to counter the body’s response to AF and heart strain, and is usually only used when other treatments are unsuccessful.

The RATE-AF trial showed there was no difference in physical wellbeing between digoxin and beta-blockers and there was no difference in the effect on long-term heart rate between the two drugs. Importantly, digoxin at low dose was found to cause substantially and significantly less adverse effects than beta-blockers, lessened the impact of AF on the daily lives of patients by improving symptoms, and reduced a marker of heart strain, natriuretic peptide.

AF is caused by disorganised electrical impulses firing from different places in the top chambers of the heart and patients usually require medication to control an irregular heartbeat. Patients can also have a reduced quality of life, be admitted to hospital more frequently and have a higher chance of strokes and heart failure.  This trial, embedded in the NHS, involved 160 patients aged 60 or older. It has addressed a major evidence gap in the management of patients with permanent atrial fibrillation. The research team will plan a larger trial to see if digoxin can reduce hospital admissions in this patient group.

Chief Investigator Professor Kotecha said: “I hope that the results of this trial show the importance of randomised clinical trials to see how treatments actually work. On behalf of the research team and all the patients who designed and took part in the RATE-AF trial, we are delighted to show that digoxin is a drug that can be used to improve the lives of patients with AF.”

The trial was publicly funded by the National Institute for Health Research (NIHR). RATE-AF was coordinated by the Institute of Cardiovascular Sciences at BHP founder member the University of Birmingham, a Patient & Public Involvement Team and the Birmingham Clinical Trials Unit. Patients and staff involved in the trial were from BHP founder member University Hospitals Birmingham NHS Foundation Trust as well as Sandwell and West Birmingham Hospitals NHS Trust and local General Practitioners.

Birmingham maternity experts call for urgent action on pregnancy ‘drug drought’

Written by Louise Stanley on . Posted in Clinical trials, Experimental medicine, Maternal health.

Leaders in maternal healthcare from Birmingham Health Partners (BHP) have called for lifesaving research into pharmaceuticals for use during pregnancy, in a new report which highlights the challenges of pregnancy-related complications, pre-term birth and pre-existing conditions.

Globally, 2.7 million women and children die each year from causes related to pregnancy and childbirth – including one death every six minutes due to pre-eclampsia. As well as pregnancy-related health conditions which develop during pregnancy, expectant mothers may be diagnosed with infections such as COVID-19 or serious diseases including cancer, and many women enter pregnancy with pre-existing conditions like asthma, diabetes or depression. Despite this, only one new drug has been developed specifically for use in pregnancy in more than 30 years, and 73% of drugs used in pregnancy come with no safety information relating to their use by pregnant women.

Experts from BHP’s founding members the University of Birmingham and Birmingham Women’s and Children’s NHS Foundation Trust are today urging politicians, clinicians, academia, industry, patients and research funders to end this ‘drug drought’ through developing and testing new and existing medicines in pregnancy, and help achieve the UK Government’s aim to halve maternal and infant deaths by 2025. The report, ‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ sets out how this crucial research can be managed to de-risk research, mitigate safety concerns and give confidence to women and their clinicians.

BHP’s Katie Morris, Professor of Obstetrics and Maternal Fetal Medicine, explained: “The COVID-19 pandemic and confusion surrounding the vaccine has brought into sharp focus the absence of pregnant women in most pharmaceutical trials. The lack of understanding of which drugs can be safely used in pregnancy combined with reluctance to develop new medicines for mothers-to-be adds up to a major global public health issue, but it’s one which could be reversed. With collaborative effort, we can stop excluding pregnant women and breastfeeding mothers from clinical research and give them access to the medicines they deserve.”

Peter Brocklehurst, Professor of Women’s Health at BHP, commented: “Pregnancy complications, including pre-term birth and pre-eclampsia have a huge impact on families and society as a whole. The consequences of preterm birth alone cost the UK economy almost £3bn annually and, while we have the ability to tackle these issues for mothers at home and abroad, we have barely begun. Many of the women and babies who die during pregnancy and birth could be saved, and 15 million babies could be spared the disability and mortality risks linked with being born too early, if we act now.”

Dr Sheuli Porkess, Medical Director at the Association of the British Pharmaceutical Industry, commented: “We completely agree on the need for action to address the needs of pregnant women and the lack of licensed medicines and treatments researched for use in pregnancy and breastfeeding.

“We have already started work, including on better representation of pregnant women in the design of and recruitment for clinical trials. We are pleased to have Maternal Health reflected in our Memorandum of Understanding with Birmingham Health Partners and to be working with our members, BHP, the MHRA, HRA and others on this important area.”

The report concludes that, through collaboration, research into medicines for pregnancy could be progressed at pace. By creating financial incentives for investment, building public-private partnerships, addressing regulatory gaps and hurdles and harnessing new technologies, the UK can directly impact the health, safety and wellbeing of pregnant women worldwide.

‘Safe and Effective Medicines for Use in Pregnancy: A Call to Action’ can be downloaded from https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/01/21560-Policy-Commission-Maternal-Health-Report-AW-accessible.pdf. Its signatories – BHP Professors Katie Morris, Peter Brocklehurst, Arri Coomarasamy and Shakila Thangaratinam – will next establish a major policy commission to review evidence, opportunities and options for policy which will be integral to the formation of clear, multi-stakeholder recommendations to the UK Government.