Clinical trials on cancer drugs ‘in jeopardy’
The Health Research Board (HRB) criticised proposed legislation drafted by the Department of Health and Children for the negative impact it will have on the level of independent medical research.
HRB chairperson Professor Desmond Fitzgerald said what was being proposed placed a question mark over a recent 5 million investment by the department for cancer clinical trials in nine hospitals.
The HRB has added its voice to growing concern among medical researchers that an EU directive due to become law next May will seriously impede current, non-commercial research.
They have complained that the draft legislation in Ireland will place extra costs and administrative burdens on clinical trials conducted by “independent” medical researchers not attached to commercial pharmaceutical interests.
Prof Fitzgerald predicted that academic clinical research would be decimated if the draft regulations were implemented.
“If changes are not made, the capacity of the health system to undertake clinical trials of the highest quality in a number of specialities, linked to improved outcome for patients, may be seriously undermined,” he warned.
Experts say trials relating to the development of new treatments for cancer and heart disease would be particularly affected. Some have suggested that a quarter of the 200 clinical trials approved by the Irish Medicines Board each year could be threatened.
Prof Fitzgerald claimed non-commercial, clinical trials could still be conducted in a manner that would respect the principle of the EU Directive as opposed to tests conducted by large pharmaceutical firms, under the draft regulations for Clinical Trials on Medicinal Products for Human Use (2003). The HRB has offered to assist the Government in facilitating a consensus among medical researchers as to possible changes to the draft legislation.
Prof Fitzgerald also expressed concern about “the lack of clarity” relating to the establishment of a supervisory body. However, he said the board’s opposition to the HRB taking on that role is on the basis that it would be “inappropriate.”
The HRB has recommended that Health Minister Micheál Martin should set up an advisory committee of people with expertise in clinical trials to advise on how the supervisory function can best be undertaken.
