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The EU Clinical Trials Regulation: Improving clinical research for children and adolescents in Europe? PDF Print E-mail
Hosted by Glenis Willmott, MEP

Wednesday, 20 February 2013

Today, 15th February, is International Childhood Cancer Day. SIOPE is taking this opportunity to call for a pragmatic approach to clinical trial governance for children and adolescents with cancer in Europe.

It is widely recognised that the conduct of collaborative clinical trials across multiple Member States has been seriously impeded by the EU Clinical Trials Directive (2001/20/EC) and there is real potential for this to be reversed by the proposed EU Clinical Trials Regulation. A meeting is being organised on 20th February in the European Parliament kindly hosted by MEP Glenis Willmott, Rapporteur of the EU Clinical Trials Regulation, to discuss how paediatric clinical research can be improved through fair regulatory governance.

The principle objective of trials for children and young people with cancer is treatment optimisation using well-established chemotherapy drugs, and the introduction of new, safe and effective innovative medicine in standard care. These trials are non-commercial, sponsored and conducted by academic institutions, and funded by public money and/ or charity support to cover the trials' organisational structures.

SIOPE and ENCCA, the European Network for Cancer research in Children and Adolescents, on behalf of the European paediatric oncology community, call for:

FAIR and proportionate regulation of childhood cancer trials, where the aim is to improve survival using medicinal products that are already in common use
FAIR and proportionate insurance for academic trials treating children with rare diseases, secured through the proposed 'national indemnity schemes'

- Read our position

- Read our proposed amendments

Every year SIOPE organises a high-level meeting at the European Parliament in Brussels to mark International Childhood Cancer Day. SIOPE and MEP Glenis Willmott have invited experts and decision-makers to discuss key aspects of the Regulation. Exceptionally this year, experts from other paediatric diseases who are members of the European Network of Paediatric Research at the European Medicines Agency will join as speakers and provide their perspective on the new legislation. We anticipate a lively and forward-looking discussion on how to improve clinical research for children and adolescents in Europe.

For more information, please contact us at office(@)siope.eu.
 
Cancer World Newsletter - Survivor services: supporting patients living with and beyond cancer PDF Print E-mail
Helping your patients make the best of their lives after treatment starts with thinking ahead before treatment and tailoring support for as long as it is needed. But evidence, knowledge and good practice about the sort of problems that are likely to arise with different cancers and different treatments, and questions about the best way to avoid or assess and manage them, and who should be involved in delivering services and how, have received scant attention outside of the US. This may change with the establishment of a new European Collaborative Group on Cancer Survivorship. In this e-grandround, Neil Aaronson, who has been leading this work, talks through some of the key issues.

What do you think?

Do oncologists and cancer nurse specialists focus enough on ensuring their patients feel and function as well as possible in the short and long term?
Do we need more systematic ways to assess needs and ensure each patient gets the level of information, support and assistance they require?

You can read the article here.
 
Cancer World Newsletter - Me and my cancer: the power of a well told personal story PDF Print E-mail
Do personal emotions and experiences have any role to play in conveying information about cancer, cancer treatments and trials? The European School of Oncology gave its answer when it awarded a Best Cancer Reporter Award special commendation to the Daily Telegraph's Cassandra Jardine, who had run a series of features pieces documenting aspects of her journey as she went through treatment for a lung cancer that eventually killed her. In this Best Reporter article, Cancer World's Simon Crompton
reviews Cassandra's reporting and looks at the power and the pitfalls of these personalised stories.

What do you think?

  • Do personal accounts inevitably compromise the accuracy, objectivity and balance that is required in conveying medical and scientific information?
  • Do patient-journalists like Cassandra convey important messages to audiences doctors and researchers can never hope to reach – and perhaps also offer doctors and researchers insights into the patient perspective that they need to hear?
You can read the article here.
 
Stop Cancer Now! Top cancer experts call for urgent global action to save millions of lives PDF Print E-mail
 On this World Cancer Day 2013, participants of the World Oncology Forum raise the alarm about the increasing devastation caused by cancer across the world. The group of international experts will call on world governments to take urgent action to halt a catastrophic increase in death and suffering from cancer across the globe, and to deliver on commitments they made at the World Health Assembly in May 2012 to cut premature deaths from non-communicable diseases, including cancer, by 25% by 2025.

To see the press release and related documents please click here.
 
Cancer World Newsletter - The reoperation lottery PDF Print E-mail

When figures from a variety of countries indicate reoperation rates in early breast cancer
are up to three times higher at some centres than others, something is clearly not right.
In this Cutting Edge, we look at some of the reasons behind this disparity and examine
the case for enforcing international consensus guidelines and quality control.

 What do you think?

  • Are women being subjected to unnecessary reoperations to achieve surgical margins
    that cannot be justified by current knowledge about the likelihood of recurrence?
  • Would stricter guidelines and quality control for pathology and surgery help?
  •  You can read the article here. Press the comment button at the end and share your views.

 
European Institute of Womens Health Cervical Cancer Policy Brief 2013 PDF Print E-mail
Unlike many other cancers, cervical cancer is uniquely preventable and in some countries such as Finland death from this cancer has been greatly reduced. Yet even today across the EU there are great disparities in mortality rates. Cervical cancer still kills far too many women in eastern EU countries such as Romania, Bulgaria, Hungary and the Baltic countries of Lithuania and Latvia.

Sadly, this cancer strikes women in their 30s and 40s at a time when many are bringing up young families or concentrating on their careers and enjoying busy lives. The cancer is a huge personal and emotional burden for women, their children, family and friends, as well as placing considerable medical and economic costs on society. And yet this is a cancer for which we have the knowledge and tools for prevention.

To see the European Institute of Womens Health Cervical Cancer Policy Brief please click here.

 
Cancer World Newsletter - Putting Knowledge to Work PDF Print E-mail
Innovative ways of visualising the biological behaviour of tumours offer huge potential for
helping guide decisions on treatment options. But with so many types of variable to take
into account – clinical, biologic, radiologic, demographic, pharmacologic – how can any
doctor be expected to make sense of it all and apply it to the patient in front of them?
They can't, says Vincenzo Valentini, president of  ESTRO (the European Society for
Radiotherapy and Oncology). In this Cover Story he calls for much closer interdisciplinary
collaboration to help develop decision models that can put our knowledge to better use.

 What do you think?

Do oncologists now have access to more data about patients and their disease than
they are able to interpret and put to good use?Is greater collaboration between disciplines needed to help make sense of all the
different types of data coming in from different fields?

You can read the article here. Press the comment button at the end and share your views.


 
Health EU-newsletter PDF Print E-mail
Health EU-newsletter presents the latest version of its newsletter, with main focus on: Revision of the Tobacco Products Directive to meet challenges in tobacco control in the EU

To see the newsletter, please click here.
 
Cancer World Newsletter - Time to act on trials PDF Print E-mail
Great opportunities to get better results for patients are being lost because of a collective
failure to organise clinical trials that can get answers to urgent questions about how best
to use therapies and in whom. This editorial argues against sitting back and waiting for the
Clinical Trials Directive to be overhauled. As has been shown in the UK, which has seen a
quadrupling of the proportion of cancer patients in trials over the past decade, much can –
and must – be done now to boost enrolment in trials across Europe.

 What do you think?

  • Is enough being done in your hospital, health region or country to promote clinical trials?
  • What in your experience are the biggest barriers to setting up trials and enrolling patients?
 You can read the article here. Press the comment button at the end and share your views.
 
Save the Date: Enhancing paediatric research in Europe through the EU Clinical Trials Regulation PDF Print E-mail
Hosted by Glenis Willmott, MEP 
 
Wednesday, 20th February 2013: 15.00-18.00

European Parliament – Room A3H-1

Rue Wiertz 60, B-1047 Brussels, Belgium

                                                                                                                                     
It is widely recognised that the conduct of collaborative clinical trials across multiple Member States has been seriously impeded by the EU Clinical Trials Directive (2001/20/EC) and there is real potential for this to be reversed by the proposed EU Clinical Trials Regulation (CTR).

The most common principal objective of children's cancer trials is treatment optimisation using well-established chemotherapy drugs and the introduction of new, safe and effective innovative medicine in standard care. These trials are non-commercial, sponsored and conducted by academic institutions and funded by public money and/or charity support to cover the trials' organisational structures.

To mark International Childhood Cancer Day, Member of the European Parliament (MEP) and EP Rapporteur of the CTR proposal, Glenis Willmott, will host an event on 20th February 2013 to discuss key issues in the legislation that affect not only paediatric oncology but also other disease areas affecting children and young people. Members of the European Medicines Agency’s European Network for Paediatric Research (EnprEMA)  will join SIOP Europe, the European Society for Paediatric Oncology (SIOPE) to discuss how to enhance and optimise paediatric clinical research through the EU Clinical Trials Regulation.

 
Places are limited!

Register by filling in the registration form downloadable here and sending it via email at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it / fax to: +32 2 775 02 00.

Registration is on a “first come, first served basis” and deadline for registration is Monday, 11th February 2013.


 
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