European drug marketing applications are increasingly supported by clinical trials conducted outside the region. In response to this a series of measures have been taken over the past six years, leading to the formation of a working group tasked with developing practical proposals.
The group has now published a reflection paper looking at the ethical and good clinical practice (GCP) aspects of clinical trials conducted outside the European Economic Area (EEA). Central to the ideas expressed in the document is the need for regulators to communicate and cooperate.
By forging stronger links with overseas regulators the working group hopes the European Medicine Agency (EMA) will be able to establish six elements that must be in place for all trials.
These goals call for: truly independent ethics committees; systems of follow-up of clinical trials; use of GCP to control studies before during and after conduct; and refusal of marketing approval if trials are noncompliant.
Ensuring these aspects are in place for all trials “is a long-term goal” which will be worked towards in a phased manner. Limited resources mean that prioritisation is required. Countries which conduct a lot of trials and those with limited regulatory systems will be prioritised.
Actions should also be complementary to initiatives implemented by other international, European, regional and national bodies in the field. This is intended to avoid duplication of efforts, ensure all necessary measures are taken and help regulators learn from previous initiatives.
After considering the priorities and other organisations’ actions the EMA should implement measures which: increase the efficiency and effectiveness of GCP inspection; improve capacity of national regulators; and motivate sponsors to ensure adequate levels of clinical trial controls.
The document also covers a number of practical and regulatory topics related to overseas clinical trials. Specifically relating to ethical standards of clinical trials the document discusses consent procedures, confidentiality, fair compensation, post-trial treatment and vulnerable populations.
Also covered are measures related to the drug development phase, including considerations for designing clinical trials, and practical steps to be take during marketing authorisation. Finally, the document provides a summary of regulatory actions.
The deadline for comments is 30 September 2010.