The EC set out the proposals in a consultation document published last week in preparation for the implementation of the new clinical trials regulation that will repeal the old clinical trials directive and its associated rules.
Stefano Soro, head of the Commission’s drug quality, safety and efficacy unit, told us “the consultation document carries over to the extent possible the principles and guidance set out in the current legislation, with the addition of certain provisions to include more detailed – and modern – arrangements.”
These more detailed and modern arrangements cover what is expected of clinical trial inspectors in European Union (EU) members states, including both their qualifications and the specific expertise that they will need.
In addition to having academic backgrounds in medicine, pharmacy or toxicology, inspectors will need to receive regular training on trial procedures and laws covering such research – including those covering “the recording and management of clinical data.”
This implies that inspectors will be required to know about trial transparency regulations adopted in 2014 to force drugmakers to publish what MEP Glenis Wilmott, rapporteur for the Clinical Trials Regulation, called the results of “unflattering” studies.
The new consultation document also specifies that inspectors will have access to a centralised database of standard operating procedures that will be maintained by each member state.
Member states are also required to keep records of training and assign each inspector with a “suitable means of identification.”
The document also makes clear that inspectors must not have financial links to trial sponsors, investigators or sites running the research and that they sign statements stating as such.
The EC wants feedback from the pharmaceutical industry, the contract research sector and other interested parties by November 24.