Author： Malcolm B. Steve W.
Publisher： Adis International
ISSN： 1364-9027
Source： International Journal of Pharmaceutical Medicine, Vol.16, Iss.4, 2002-08, pp. : 179-183
Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.
Abstract
We assessed the potential impact of the European Union (EU) Clinical Trials Directive (CTD) on studies of investigational medicinal products (IMPs) in healthy volunteers using data from our studies in 19932001. The main outcome measures were time to approval of applications, including protocol amendments, by the research ethics committee (REC); types of study; types of study drug; and country of origin of sponsors. Of 312 applications to the REC, 208 (67%) were approved and 104 (33%) were approved conditionally at first review. We completed 280 (90%) studies. Ninety-five (34%) were sponsored by UK companies and 185 (66%) were sponsored by companies in 15 other countries. Seventy (25%) studies were first-administration-to-man studies. One hundred and sixty-six (61%) of 274 study drugs were new molecules. Forty-two per cent of IMPs were manufactured or imported from countries outside the EU. The median time from application to written approval by the REC was 19 days. We completed 181 (65%) studies without amending the protocol. During the other 99 (35%) studies, we submitted 167 protocol amendments for REC review. One hundred and forty-three (86%) amendments were for expedited review. The median time from request to written approval was 4 days. We conclude that ethical review was fast, and that successful completion of many studies was dependent on protocol amendments. When the CTD is implemented, almost all of our studies will require simultaneous applications to the Medicines Control Agency (MCA) and the REC. MCA response times will have to match REC times if we are to continue to carry out studies efficiently and to attract overseas sponsors, as recommended by the Pharmaceutical Industry Competitiveness Task Force (PICTF). When guidelines that support the CTD are written, they should include sensible definitions of protocol changes that require submission to the MCA and the REC, and they should have reasonable requirements for manufacturing, reconstituting and packaging IMPs from outside the EU. The notification procedure should be as simple as possible. Also, RECs should ensure that when they implement the new Governance Arrangements for National Health Service Research Ethics Committees (GAREC), there is no conflict with the CTD about procedures for reviewing protocol changes.
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