UK well positioned for Exploratory Clinical Development

Dr Cyril Clarke BSc, MB BS, MFPM • Medical and Scientific Vice President, Clinical Pharmacology,
ICON Development Solutions / Dr David Shaw PhD, CBiol MIBiol, MTOPRA • Senior Director Regulatory Affairs, ICON Development Solutions

The decision to outsource elements of early development to a CRO and the subsequent choice of regulatory jurisdiction is one of the key challenges facing clinical development teams as we move towards the end of the first decade of the 21st century. Historically, the UK has been one of the preferred locations for conducting early phase clinical development. However, the introduction of the EU Clinical Trial Directive in 2004 and the regulatory focus that followed the well publicised adverse event during the TGN1412 study has created a perception that the UK is becoming a difficult place to conduct early phase clinical development due to increased regulatory bureaucracy and inflexibility. This has led some sponsors to conduct Phase I and, in particular, first-in-human (FIH) elsewhere within Europe and the US. However, a closer look at the regulatory environment reveals a far more encouraging picture.

Background: The EU Clinical Trial Directive

Organizations that conduct Phase I studies were particularly affected by the EU Clinical Trial Directive. The Directive established a standard EU procedure for all clinical trials (other than those that are non-interventional), including bioavailability and bioequivalence studies. In addition to a common system for authorization and control, a central monitoring system (the EudraCT database) was introduced. In the UK, Phase I pharmacology studies now require authorization from the Medicines and Healthcare products Regulatory Agency (MHRA), whereas previously they only needed a favourable opinion from an ethics committee.