§ Mr. Pavittasked the Secretary of State for Social Services what arrangements his Department has made to safeguard patients in the clinical testing of the potential new anti-cancer drug AT–125.
§ Mr. MoyleAn application for a clinical trial of AT–125 would be expected to include all the relevant data on quality, safety and expectation of therapeutic efficacy that is requested for any substance that is intended for application to man in a clinical study. These requirements are laid out in "Notes on Applications for Clinical Trial Certificates" (MAL 4) issued by the licensing authority. The advice of the Committee on Safety of Medicines would be sought before considering whether or not to approve the issue of a clinical trial certificate. The506W Committee would also advise on particular safety monitoring additional to any that the applicant would routinely include.
I have placed a copy of MAL 4 in the House of Commons Library.