§ Mr. Simon HughesTo ask the Secretary of State for Health (1) how many volunteers who took part in clinical trials in the United Kingdom have died or suffered serious injury in each of the last 10 years for which figures are available; what procedures his Department has in place to ensure minimisation of risk to such volunteers; and if he will make a statement; [19274]
(2) what procedures (a) his Department and (b) the Medicines Control Agency have in place to ensure that commercial organisations obtain valid, independent ethical approval before conducting clinical drug trials on healthy volunteers. [19268]
§ Mr. MaloneThese figures are not collected centrally and no data are available.
Volunteers who take part in clinical trials are protected by a variety of mechanisms designed to minimise the risk to the subjects. People who take part in any form of drug study are volunteers who do so on the basis of informed consent. Informed consent means that the purpose of the trial is explained to the subject together with what is known about the drug, any questions that the volunteer may have are answered and the potential volunteer is given the opportunity to decline to take part without it affecting his future treatment.
Studies on healthy volunteers, where there is no expectation of therapeutic benefit, do not meet the definition of a clinical trial given in section 31 of the Medicines Act 1968 and are not controlled by the Act. Companies carrying out such studies are self-regulated and, under an Association of British Pharmaceutical Industries code of practice for all pharmaceutical companies, companies are required to obtain the approval of an independent ethics committee before conducting studies on healthy volunteers. These studies are carried out in specialist units by experienced medical staff who have ready access to the appropriate support facilities to ensure the safety of those taking part.
In general, studies in patients are covered by the Medicines Act 1968 and it is necessary for any pharmaceutical company to gain the permission of the Licensing Authority before carrying out such studies. The principal control scheme for company-sponsored clinical trials in the UK is currently the CTX scheme—exemption from the need to hold a clinical trials certificate—covered by The Medicines (Exemption from Licences) (Clinical Trials) Order 1995 (SI 2808) and The Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995 (SI 2809). Under the CTX scheme, all studies must be performed to good clinical practice standards and these include a review of the study by an independent ethics committee before the study commences. Companies applying to carry out trials under the CTX scheme give an undertaking that the Medicines Control Agency, acting on behalf of the Licensing 268W Authority, will be notified of any refusal by an independent ethics committee to approve the trial as proposed by the company.
Additionally, under the CTX scheme, companies must report the occurrence of serious, unexpected adverse drug reactions detected during trials taking place anywhere in the world to the MCA, which carefully reviews these data in order to decide whether or not trials in the UK with that drug should be allowed to continue. In any year, about 10 to 15 per cent. of trials applications are refused and a small number of approved trials have their conditions modified by the MCA because of safety concerns about the drug and its proposed use. The MCA does not collect total figures for adverse events and deaths across all clinical trials because such data would not be helpful in the assessment of the safety of an individual drug undergoing clinical trials.
The combination of informed consent, review by an independent ethics committee and constant monitoring of safety data by the MCA has been in operation for many years and has served well in the protection of public health while at the same time allowing the rapid development of new drugs to treat patients.