‘(More) trials and tribulations’: the effect of the EU directive on clinical trials in intensive care and emergency medicine, five years after its implementation

Abstract

The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by EU member states. Critical care research has been particularly impacted due to variable and often restrictive consenting procedures for incapacitated subjects, with some countries requiring a court-appointed representative, while others recognise consent from family members and occasionally professional representatives. Furthermore, the absence of a waiver of consent threatened to put an end to emergency research in Europe and was met with varied responses. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multi-centre trials. Although evidence is somewhat mixed, this complexity as well as a general increase in administrative and financial burden following the Directive has been shown to cause a reduction in clinical trial activity in Europe, particularly academic trials. We aim to clarify some of these inconsistent procedures, particularly those relating to informed consent of incapacitated subjects, as well as discussing some general weaknesses and possible improvements of the Directive ahead of its planned revision in 2011.

Research involving subjects with Alzheimer’s disease in Italy: the possible role of family members

“…Information on European legislations has been compiled [15-17] and the issue has been discussed in a significant number of commentaries [18-22]. …”

Beantragung der Bewilligung von akademischen Multicenterstudien bei deutschen Ethikkommissionen

“…In zahlreichen Publikationen wurde seither massive Kritik sowohl an der nationalen als auch an der europäischen Gesetzgebung geäußert [8,9,10,11,12,13,14,15,16,17,18]. Die EU-Kommission hat im Jahr 2011 einen öffentlichen Konsultationsprozess zur Novellierung der Direktive begonnen und in ihrer Einleitung erkennen lassen, dass die Hemmung der unabhängigen klinischen Forschung als Problem durchaus erkannt wurde [19].…”

Does the new EU Regulation on clinical trials adequately protect vulnerable research participants?

“…After almost two years of discussions, the EU Parliament and the Council adopted in April 2014 the new Regulation N o 536/2014 [7], which will replace in May 2016 the currently applicable 2001 Clinical Trials Directive (CTD) [8]. The latter did not measure up to the hopes that had been placed in it and is deemed partly responsible for the significant increase in costs and delays for the conduct of clinical trials, and for the recent 25% decline of the number of clinical trials in the EU [9]. These problems were particularly exacerbated for multinational clinical trials -which concern almost any trial involving more than 40 research participants -because of the discrepancies between Member States in the transposition of the CTD into national law.…”