Clinical trials statutory requirements

In view of the regulatory delay that was caused by the need to apply for a CTC, a Statutory Order (SI 1974/498) was made during 1974, to provide an exemption from the need to hold a CTC in such cases, subject to certain conditions. This order applied to trials conducted by doctors and dentists on their own responsibility (DDX). The basis of the clinical trial exemption (CTX) scheme, introduced in 1981, to include studies initiated by the pharmaceutical industry, was that together with a detailed clinical trial protocol and summaries of chemical, pharmaceutical, pharmacological, pharmacokinetic, toxicological and human volunteer studies, a clinical trial in patients may proceed without the need for the additional details normally required for a CTC or Product Licence application. This exemption scheme was based on the requirements that ... 

The LA had 35 days to respond to the notification to proceed with a clinical trial but could in exceptional circumstances require a further 28 days to consider the notification, if the CTX was refused, the applicant could apply for a CTC, in which case complete data had to be filed, if the CTC application was refused the statutory appeal procedures came into play if the applicant company wished to avail itself of this provision. These appeal procedures were identical with those applying to marketing applications. The CTX scheme proved highly successful in encouraging inward investment into research in the United Kingdom, in a sample of 42 companies, an increase in research investment of 10% or more was attributed to the scheme by 23 of them. its implementation was criticised by consumer groups and its effect was carefully monitored every 6 months to ensure that no added risk to patients had been introduced. 

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