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.

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.

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.

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?

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.

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.

Hematology Association of Ireland Clinical, Education and Scientific Research Sub-Committees

Research and Education / Travel Grants
The Haematology Association of Ireland invites submissions from interested individuals to the Scholarship fund for the following awards.

The Taoiseach Mr Bertie Ahern recently opened the new €1.5 million Mater University Hospital Institute for Cancer Research, the new Department of Postgraduate Education and the Fintan Gunne Lecture Theatre, all at 48 Eccles Street, Dublin.

Tánaiste, Mary Harney, Minister for Health and Children will focus on the need to harness research and development potential within the Health Services, tonight, 7 October 2004, when she opens a seminar organised by the Health Research Board.

Thursday September 30, 11:28 am ET
By Linda A. Johnson, AP Business Writer

Merck Stops Vioxx Sales Due to Data Showing Increased Risk of Heart Attack, Stroke; Stock Falls
TRENTON, N.J. (AP) — Pharmaceutical giant Merck & Co. is halting worldwide sales of its blockbuster arthritis drug Vioxx, once viewed as possibly being able to prevent some cancers, because new data from a clinical trial found an increased risk of heart attack and stroke. Its stock price plunged more than 26 percent as the company said the recall will hurt its earnings.