Vol. 352 No. 4
asked the Minister for Health the name and location of all first phase drug trial centres in the country; if any of these centres are hospital based; the number of subjects that have passed through each of these centres in each of the last five years; the number of persons who have undergone more than one test in any one centre in the past year; and the number of people who have undergone tests in more than one centre in the past year.
413.
asked the Minister for Health the measures he is taking to monitor (1) the activities of drug trial centres which carry out first phase testing, and (2) the activities of drug trial centres which carry out second phase tests on patients suffering from conditions for which the drug is intended; and if he is satisfied that there is adequate independent ethical monitoring of the committees.
414.
asked the Minister for Health if he is satisfied with the system whereby people are offered financial inducements to undergo drug trials, particularly as many of those to whom the inducements are offered are socially and financially disadvantaged.
415.
asked the Minister for Health if he will consider introducing legislation to protect the rights and safety of people attending drug trial centres, particularly to ensure that (a) the subject's general practitioner is consulted prior to the following two trial phases and (b) require these centres to follow up those who have completed trials.
I propose to take Questions Nos. 412 to 415, inclusive, together. Details as requested by the Deputy in relation to the locations in which first phase drug trials have been conducted and in relation to numbers participating in such trials are not at present available in definitive form.
As I announced on 25 June 1984, I have decided to seek Government approval for the introduction of legislation which would lay down formal conditions for all clinical trials conducted in this country. This statutory scheme, which I have had under consideration since December last, will replace the present voluntary arrangements for the clearance of submissions for trials through the National Drugs Advisory Board. Both existing and proposed new drugs will be covered. The legislation will in particular control the participation of all persons in such trials.
The formal scheme will involve a review of existing arrangements whereby ethical committees have been established in the various centres where trials are carried out to consider proposals for clinical investigations. Regarding the question of payments to participants in trials this whole question is part of the current review being undertaken.
