Statement by the Minister for Health & Children Mary Harney, T.D. on Cancer Research

Commenting on the publication today of the European Cancer Research Managers Forum Second European Survey the Minister for Health and Children, Mary Harney T.D. said: “This report analyses how cancer research is funded and enables us to monitor our progress in cancer research funding in relation to our European counterparts.”

New cancer specialist centres named

A new plan, announce by the Health Service Executive, sees eight hospitals in Dublin, Cork, Limerick, Waterford and Galway becoming the major specialist cancer centres.

But it also involves the immediate closure of cancer services at 13 other hospitals around the country.

Re-launch of ICORG website

ICORG are pleased to announce the re-launch of the company’s website (http://www.icorg.ie)

In addition to the existing sections, the updated website includes a patient focused area with information on current clinical trials available in Ireland. The members’ area now includes information relating to all Disease Specific SubGroups, which allows members to view meeting dates, current group members and minutes of previous meetings. Members will also be able to view an extensive list of all ICORG studies, from which protocols and Patient Information Leaflets may be downloaded directly.

There will be an introduction to the new ICORG website at the Scientific and Educations meeting on the 21st September in the Fitzwilliam Hotel.

Dublin, 09 July 2007

The Irish Pharmaceutical Healthcare Association (IPHA) welcomes the introduction of a standard HSE Clinical Trial Indemnity Form (HSE CTIF) for the conduct of clinical trials in Ireland. This will facilitate the effective and timely initiation of clinical trials and remove administrative barriers created by individual trial centres reviewing the same indemnity agreement for each and every single trial.

CIS Confirms Cover For All ICORG International Investigator Led Studies

The State Claims Agency have confirmed to all hospitals that CIS cover will extend to cover Investigators and Hospital enterprises from claims arising from design or protocol in relation to all ICORG conducted trials, where ICORG is listed as sponsor. ICORG would like to extend its’ gratitude to the State Claims Agency for its’ ongoing, prompt and apt support.

Pharmacovigilance

ICORG are pleased to announce the development of our dedicated Pharmacovigilance Unit as of May 1st 2007. At a time when drug safety concerns have become increasingly important in public health and modern clinical practice, the Pharmacovigilance Unit is designed to evaluate the ongoing safety of investigational drugs and also provide notification to all concerned members of any findings that could adversely affect the health of patients enrolled on ICORG studies. This is performed in accordance with the EU Directive 2001/20/EC and ICH-GCP guidelines and will continue to develop in response to the special needs of members.

Clarification of EU Directive on Clinical Trials

The definition and responsibilities of sponsor are given in Article 2 of Directive 2001/20/EC

(e) ‘sponsor’: an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial;

How should this definition be interpreted?

Joint Research Fellowships in Cancer

Dear Consortium Colleague:

A link to information about the new Joint Research Fellowships in Cancer is now available on the Ireland-Northern Ireland-National Cancer Institute Cancer Consortium Web site at http://www.allirelandnci.org.
As part of its 2005 Consortium activities, the Health Research Board in Ireland in association with the National Cancer Institute in the U.S. announced this new annual fellowship programme for post-doctoral researchers. Interested researchers are encouraged to review online information about the requirements and application process.

Adjuvant hormonal therapy added to radiation therapy for localized prostate cancer

Prof J Armstrong, Consultant Radiation Oncologist at UCD, examines the biological behaviour and treatment of prostate cancer

The biological behaviour of prostate cancer can be predicted using clinically- available data. The combination of clinical stage, tumour grade (usually described as Gleason score, a method of grading histology — high scores have a bad prognosis) and the level of prostate specific antigen (PSA) can be used to predict the risk category of individual patients. The TNM staging system is described it Table 1.