The Medicines and Healthcare products Regulatory Agency (MHRA) is welcoming applications for the Early Access to Medicines Scheme (EAMS) from the pharmaceutical industry and research organisations.
This scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation and where there are no suitable alternative licensed treatments.
There are two parts to the scheme. The first is a promising innovation medicine (PIM) designation which will be given after assessment of clinical data and provides an early indication that the specific product has potential for the EAMS scheme.
The second is where a scientific opinion is issued based on the benefit risk profile of the medicine. Positive scientific opinions will be made available on the MHRA’s website to assist doctors and patients in making treatment decisions, and inform them of the risks and benefits of the product.
The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than £284m a year to support the delivery of clinical research studies in the NHS, has reconfigured and will be operating in a new streamlined structure from April 1st, 2014.
Until this point, the Network has comprised 102 overlapping local networks, each supporting clinical research studies in different therapy areas or parts of the service. From April 2014, this has been rationalized into 15 local Clinical Research Networks across England, which will deliver studies across all therapy areas.
The geographical boundaries of the Networks correlate with those of the Academic Health Science Networks, although the remits of the two organisations remain separate.
Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, explained: “The ability to conduct clinical research is hugely important to the future of the NHS because it is the way we gather evidence to improve the quality of care for patients. Over the last year we have seen significant changes in both the NHS environment, and in the nature of research studies. It was important for the Network to evolve, so we can continue to provide the flexible infrastructure the research community needs to conduct clinical studies efficiently in the NHS.”
The HRA welcomes the announcement of funding for plans for HRA Assessment and Approval. This funding means that the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.
These proposals will build on recent improvements in timelines for approvals, will radically simplify the regulation of research and will remove complexity for researchers and industry.
The HRA will now streamline this complex process, with the HRA’s Approval addressing practical, legal and ethical aspects of the study. This will allow local research teams to work with their NHS trust to set up and deliver the study.
The Department for Business, Innovation and Skills (BIS) and the Department of Health (DH) have announced that they are joining their life sciences functions to create a new, expanded Office for Life Sciences.
The new joint Office for Life Sciences will lead the government’s efforts to:
- make the UK the best place to invest in life sciences research
- take advantage of the UK’s science base and unique NHS to improve healthcare and contribute to economic growth
BIS and DH have appointed Nicole Mather as the Director for the new Office for Life Sciences. Nicole has a DPhil in Neuroscience and is a Director in Deloitte’s Healthcare and Life Sciences practice. She will take up post on the 22 April.
Commenting on her appointment, Nicole Mather said, “I am delighted to have been appointed to this exciting new role. I look forward to working with colleagues across government, industry, academia and charities to drive growth through the expansion of the life sciences industry in the UK, supporting increased joint working with the NHS and improving access to products that make a quantifiable difference for patients.”
The NIHR Clinical Research Network has announced that it reached a milestone in study set up achievements by recruiting 25 first global patients in commercial studies in the 2013/14 financial year.
The 25th study to make this highly sought after achievement was at Manchester Royal Eye Hospital, a site of the Central Manchester University Hospitals NHS Foundation Trust. It aims to build on existing safety and effectiveness data for ocriplasmin, a treatment for some people with the rare eye condition, vitreomacular traction.
Recruiting a first global patient is a key performance indicator for the life-sciences industry in clinical research delivery as it shows the Network can support the rapid set-up of studies.
Since the Network started to record first global patients, it has achieved 42 in total. But it is during the past financial year that it has seen a rapid upturn in the number of studies to make the achievement. This is down to the reduction of study set-up times.
Researchers from the National Institute for Health Research (NIHR) have secured a major £750,000 grant from leading research charity Parkinson’s UK, to search for elusive Parkinson’s biomarkers. The announcement comes on the first day of the G8 Dementia Summit in London.
The award is to a team of researchers from London, Cambridge, Oxford, and Newcastle, and led by Professor Simon Lovestone, Director of the NIHR Dementia Translational Research Collaboration, to enable them to search for biomarkers. This new research will use blood samples and information collected through the largest ever in-depth study of people with Parkinson’s, ‘Tracking Parkinson’s’, also funded by Parkinson’s UK, which started in 2012.
Finding a reliable biomarker is a goal for many Parkinson’s researchers as it would transform the diagnosis and management of the condition. As there have been no significant developments in new Parkinson’s drugs for many years, it would also speed up research to find the next generation of treatments, which it is hoped would be able to slow or stop the progression of the condition.
The team of researchers from NIHR Biomedical Research Centres and Units in Cambridge, Oxford, London and Newcastle, as well as leading UK and US biotechnology companies, will look for biomarkers for Parkinson’s in both blood and in cerebrospinal fluid.
Professor Lovestone said: “This study is very important as finding Parkinson’s biomarkers could be essential to developing future treatments. We’ve seen huge leaps in other conditions like some forms of cancer, where biomarkers have been identified, and a blood test for Alzheimer’s is now looking hopeful. We need to do the same for Parkinson’s”.
The Health Research Authority (HRA) is launching a call for evidence to identify good practice in identifying potential participants in health research.
Building on their remit to protect and promote the interests of patients and the public in health research, they are asking for examples in the areas in which we are directly involved as well as broader successful participation initiatives.
The revisions to the NHS Constitution have committed the health service to recognising and promoting the value of research, and the Health and Social Care Act 2012 placed obligations on NHS organisations to support this.
People can contribute by completing a brief survey and returning it to email@example.com by 31 January 2014.
The HRA are interested to hear about the impact of changing recruitment strategies on recruitment and retention rates, and are particularly keen to hear about examples of patient and public engagement around models of recruitment, and evidence about patient and public expectations relating to the identification of participants.
The outcome will be published on www.hra.nhs.uk to enable the research community to benefit from the best ideas in the NHS.
The Health Research Authority (HRA) has published practical guidance to clarify how the registration of all trials, required from 30 September, will work. All applications that receive a favourable ethical opinion from a Research Ethics Committee (REC) will, as a condition of that favourable opinion, be required to be registered in a publicly accessible trial register.
Accepted registers include the
The expectation is that all studies are to be registered before the first participant is recruited. However, research awarded a favourable opinion from a REC after 30 September 2013 will not be considered to be in breach of the favourable ethical opinion if the study is registered within 6 weeks of the first participant having been recruited (or, for medical device studies, within the timeline determined by the current registration and publication decision trees).
The UK House of Commons Science and Technology Committee has described the current lack of transparency of many clinical trials as “unacceptable”, adding that it has not been impressed with Government efforts to tackle the problem to date. The committee has taken written and oral evidence over the past 9 months, and has recently published its report.
Committee Chair Andrew Miller MP said: “We consider that all trials conducted on NHS treatments—and all other trials receiving public funding—should be prospectively registered and their results published in a scientific journal. While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publically funded.” The Committee also asked the Government to take steps to facilitate greater sharing of the raw data generated during a trial.
The Report also drew attention to the recent fall in the number of trials taking place in the UK, stating that the UK was a “particularly challenging” place in which to conduct a trial. It found that the need for multiple governance approvals from participating NHS organisations remained the biggest barrier to setting up a UK trial, but that lack of public awareness was also a key issue.
The Report called on the Government to take its recommendations into account in ongoing discussions regarding the revision of European clinical trials legislation and in its response to the European Medicines Agency’s consultation on the release of clinical trial data, which closes at the end of this month.
The Department of Health, through the National Institute for Health Research (NIHR) has announced the 15 NHS Trusts/Foundation Trusts that will host the local branches of the NIHR Clinical Research Network from April 2014.
The NIHR Local Clinical Research Networks will distribute £280 million of NIHR funding per year to hospitals and surgeries across England to, pay for research nurses, scans, x-rays and other costs associated with carrying out clinical research in the NHS. The Networks will help to increase the opportunities for patients to take part in clinical research, and will be responsible for making sure that studies are carried out efficiently. They will also support the Government’s Strategy for UK Life Sciences by improving the environment for life-sciences research in the NHS.
Last year, more than 630,000 patients took part in clinical research studies supported by the NIHR Clinical Research Network.