Clinical trials regulations

The rules governing clinical trials in the United Kingdom are now set out in the Medicines for Human Use (Clinical Trials) Regulations 2004, which implement Directive 2001/20/EC on good clinical practice in the conduct of clinical trials. 

A specified party must hold or obtain (and maintain) all necessary authorisations, for example, under the UK Medicines for Human Use (Clinical Trial) Regulations 2004, and sub-ordinate/related legislation, the Data Protection Act 1998 and the Animals (Scientific Procedures) Act 1986. 

The Medicines for Human Use (Clinical Trials) Regulations 2004, Statutory Instrument 2004, No. 1031, HMSO. 

Induction training in QA may comprise the general audit procedures employed at the company, key audit SOPs and documentation requirements in QA. A thorough review of the regulatory framework for GCP is recommended, as QA auditors are expected to be experts for clinical trial regulations and all GCP aspects. It would impair the QA auditors credibility if they knew less than the auditees of the requirements that must be adhered to in drug development. 

Committee (GTAC), which is recognised as a specialist committee by UKECA under the Clinical Trials Regulations. 

Under the clinical trials regulations, an REC is required to give an ethical opinion on an application relating to a CTIMP within 60 calendar days of the receipt of a valid application. Where the REC considers that fnrther information is required in order to give an opinion, the REC may make one request in writing for further information from the applicant. The period of 60 days will be suspended pending receipt of this information. 

TMew clinical trial regulation is less stringent for diagnostic radiopharmaceuticals [9]... 

PTKs have been implicated in the regulation of a variety of biological responses such as cell proliferation, migration, differentiation, and survival. They have been demonstrated to play significant roles in the development of many disease states, including immunodeficiency, atherosclerosis, psoriasis, osteoporosis, diabetes, and cancer. In recent clinical trials impressive antitumor effects of PTK inhibitors have been observed. In future, PTK inhibitors may therefore become important drugs for the treatment of specific cancers. 

There are a number of other regulations/directives that you will need to consult, as appropriate. These address topics such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), the conduct of clinical trials, variations to authorised drugs, and the use of genetically modified organisms. A list of the most relevant directives is shown in Table 1.5. 

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 

To generate sufficient data so as to convince the regulators that it safe and worthwhile to proceed to clinical trials with human subjects. 

These principles of GCP have been incorporated into regulations that govern the initiation and conduct of clinical trials. The process for undertaking clinical trials in the EU and the US shall now be examined. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

The Competent Authorities are obliged to appoint Inspectors for checking that all activities associated with clinical trials are conducted in compliance with the regulations. The inspectors can inspect any sites concerned with the clinical trial, particularly the trial site (GCP), the manufacturing site of the investigational medicinal product (GMP), any laboratory used for analyses in the clinical trial (GLP), and/or the sponsor s premises. 

The relevant regulations governing the conduct of clinical trials in the U S are shown in Table 5.4. As they also reflect the principles of GCP, they are quite similar in requirements to those of the E U. However, because they apply to a single jurisdiction, they are framed to provide more prescriptive detail than can be found in the equivalent EU directives. Similarly, they are supported by the ICH- and FDA-specific guidelines. As most of the practices are the same as discussed in the previous section, the chapter will now just examine some of the aspects that are unique to the US regulations. 

Table 5.4 Code of Federal Regulations Parts relevant to Clinical Trials.

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