Europe’s New Clinical Trials Landscape Looms Large

The clinical research community in Europe is bracing itself for major change. Clinical Trials Regulation 536/2014 is due to come into force toward the end of 2018, when the legislation becomes a regulation rather than a directive, and this development should ensure that the same rules are applied throughout the European Union (EU). 

Importantly, the European Forum for GCP (EFGCP) has announced that meeting the ethical standards under the regulation will be the main theme of its annual conference, to be held in Brussels, on Feb. 21-22, 2017. The program will focus on the burning questions (and answers) for researchers, sponsors and patients. 

“The regulation is now less than two years away and if we are to grasp this opportunity to improve research and regulation for patient benefit, it’s imperative we look together-public, patients, researchers and regulators-at both the procedural requirements and ethical changes required,” noted EFGCP in a statement. 

The forum says it has taken an active role in the new regulation. Its plan at the Brussels event is to discuss procedural arrangements already underway and to address the challenges that the regulation presents, providing an opportunity for debate, as well as giving access to expertise and examples of how these challenges can be met. Workshops will be led by specialists who can offer support and solve problems. 

Furthermore, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has devised a list of the main characteristics of the regulation:

• A streamlined application procedure via a single entry point, the EU portal, plus a single set of documents to be prepared and submitted for the clinical trial application. 

• A harmonized procedure for the assessment of applications for clinical trials, which is divided into two parts. Part I will be jointly assessed by all member states concerned, which means the countries where the trial is intended to be conducted. Part II will be assessed by each member state concerned separately. 

• The involvement of ethics committees in the assessment procedure, in accordance with the national law of the member state concerned but within the overall timelines defined by the regulation.

• Extension of the tacit agreement principle to the authorization process, which will give sponsors increased legal certainty, without compromising safety, as well as streamlined safety reporting procedures that will spare sponsors from submitting broadly identical information separately to various bodies and different member states. 

• Increased transparency with regards clinical trials and their outcomes.

• Union controls in member states and third-party countries to ensure that clinical trials rules are being properly supervised and enforced.

Clinical trials conducted outside the EU, but referred to in a trial application within the EU, will have to comply with the regulatory requirements that are at least equivalent to those applicable in the EU. 

EFPIA sees the regulation as an opportunity to demonstrate Europe’s commitment to clinical innovation, scientific collaboration and transparency of clinical trials information. To implement the regulation and achieve the core objectives, it has identified three priorities: deliver flexible, efficient and streamlined execution of the authorization procedure to avoid administrative delays; enable the required collaboration between concerned member states and sponsors; and appropriately manage the transparency of data over the life of the study. 

Along with its national members, EFPIA says it is monitoring the implementation of the regulation at the national level through its National Trade Association Clinical Trials Implementation Monitor survey. 

Once the regulation becomes effective, it will replace EU Directive 2001/20/EC, though clinical trials that started before the new regulation comes into force may continue to use the rules in the directive for three years from the regulation’s effective date, according to the International Society for Pharmaceutical Engineering (ISPE). Sponsors can opt for the old system within one year of the regulation’s effective date and operate under the directive for a three-year transition period.

ISPE points out: “The overarching change enacted by the regulation is the centralization of the clinical trial application process. Under the regulation, a proposed study’s clinical trial application will be submitted electronically through a new electronic portal. The centralized submission will trigger review by representatives from the individual member states in which the sponsor is requesting the trial be conducted.

Once an application is received, a single member state is chosen to lead the assessment. The reporting member state may be the state that is requested by the sponsor, or a state may volunteer to lead the assessment. With input from other member states, the reporting state validates the application or sends queries to the sponsor requesting further details. Individual member states can refuse to authorize the clinical study in their countries.