HL Deb 15 March 2004 vol 659 c20WA
Baroness Greengross

asked Her Majesty's Government:

Whether there are, or will be, any requirements to include people aged over 65 in clinical trials which evaluate the safety and efficacy of drugs and treatments. [HL1815]

Lord Warner

The Medicines and Healthcare products Regulatory Agency, on behalf of the Licensing Authority, grants marketing authorisations for medicinal products provided that satisfactory quality, safety and efficacy data have been submitted for the medicinal product for use in the proposed indication and that the risk benefit is deemed favourable. Part of the assessment process involves ensuring that the target population to be treated once the medicine is licensed has been adequately represented (including age, gender, ethnicity) in the clincial trials submitted in support of the application. There are regulatory guidelines that specify the inclusion of the elderly in clinical trials if they are likely to be included in the population to be treated.