Focus group tackles better outcomes for EU cancer patients
Friday, 20 November 2015 10:34
Press Release: Brussels, 19 November 2015 More than 1.75 million citizens die from cancer every year in the EU, and Europe’s ageing population will significantly increases the incidence of cancer over the next two decades.
The Brussels-based European Alliance for Personalised Medicine (EAPM) has published a series of articles in an international online health magazine as part of the work of its EU Consensus Group on Clinical Trials. The articles have appeared in a special edition of Public Health Genomics under the title Getting Personal: The Future of Medicine and Clinical Trials. This is the first stage of the multi-stakeholder team’s activity and their articles attempt to address whether a personalised medicine-enabled clinical research and trial strategy can produce better outcomes for cancer patients across Europe’s 28 Member States. The second stage of their activity will be prioritising the challenges and proposing workable solutions.
The authors have stated that “Now is the time to deliver focused solutions that will improve outcomes for cancer patients in Europe.” An important part of the work undertaken by EAPM concerns clinical trials and patient access to them. Indeed, one of the four-year-old Alliance’s main aims is tackling the broader issues of personalised medicine in terms of clinical trials, as well as biobanks, data sharing, EU regulations and more, while looking towards the EU’s Horizon 2020 initiative.
Clinical trials are vital to patients and the advancement of cures for a multitude of diseases, but the issues surrounding countrywide and, even more so, pan-European trials and their application in modern-day medicine are complex.
The consensus panel was brought together in an attempt to define how personalised medicine cancer clinical trials should be organised in order to direct patients to the most appropriate research as well as addressing important unmet needs.
One crucial issue is the question of how clinical trials should best be run to maximise the effectiveness of personalised medicine initiatives which make the best provision for access for appropriate patients.
Another main aim is to determine how to structure cross-border clinical trials by enabling collaboration and minimising regulatory burdens.
And a further goal is to determine how to solve the problem of ensuring that clinical trials can be held and financed in the most efficient way possible.
From an original roundtable in Madrid, EAPM’s EU Consensus Group has since held a series of face-to-face meetings and telephone conferences in order to identify key challenges.
These involve the reality that: the cancer drug development model is no longer fit for purpose; the traditional clinical trials framework does not support a personalised medicine strategy, and; escalating costs of cancer health care undermine clinical innovation.
The panel also found that a lack of clinically validated biomarkers hampers a personalised medicine-enabled approach, and that current European legislative reform threatens clinical cancer research.
Meanwhile, they say, a lack of understanding and insufficient patient involvement undermines participation in clinical research, while an absence of cooperation between different stakeholders lessens the effectiveness of personalised medicine implementation.
The articles are available to read at the following link.
Denis Horgan, EAPM Executive Director, EAPM, Avenue de l'Armee/ Legerlaan 10, 1040 Brussels, Belgium Ph: + 32 4725 35 104 Website: www.euapm.eu
The European Alliance for Personalised Medicine brings together Europe's leading healthcare experts and patient advocates to improve patient care by accelerating the development, delivery and uptake of personalised medicine and diagnostics. It is calling for the European Commission, the European Parliament and EU member states to help improve the regulatory environment so that patients can have early access to personalised medicine, and so that research is boosted.
MRC guidance on obtaining data from the Health and Social Care Information Centre
Thursday, 19 November 2015 16:12
The MRC Regulatory Support Centre has been working in partnership with researchers and regulators to develop a number of resources that support health informatics research. These can be found on the MRC website. This page launches the latest guidance "Obtaining data from the Health and Social Care Information Centre (HSCIC) for health research". Following on from the barriers analysis conducted earlier in the year, this practical guide for researchers includes tips on obtaining the necessary approvals. It was developed jointly with the HSCIC and will be a living document, updated regularly as HSCIC processes evolve. The latest version is dated 28/10/2015.
Statement supporting European Directive 2010/63/EU on the protection of animals used for scientific purposes
Tuesday, 10 November 2015 11:50
Tuesday, 13 October 2015 08:44
BSG members and others from the CONFIDeNT study group have reported in The Lancet on the results of their HTA-funded double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial of the use of percutaneous tibial nerve stimulation (PTNS) in comparison with sham electrical stimulation in adults with faecal incontinence. They write that "PTNS given for 12 weeks did not confer significant clinical benefit over sham electrical stimulation in the treatment of adults with faecal incontinence. Further studies are warranted to determine its efficacy in the long term, and in patient subgroups (ie, those with urgency)."
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