EMA Issues New Paper on Advancing Ethical Regulatory Framework for Clinical Trials

The European Medicines Agency (EMA) released a new reflection paper on how to advance the regulatory framework overseeing clinical trials, including how to strengthen clinical trials oversight.

EMA's 16 April Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorization applications to the EU Regulatory Authorities seeks to "strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required ethical and GCP standards, no matter where in the world they have been conducted," wrote EMA in a statement.

"The reflection paper is part of the Agency's strategy developed to address the challenges arising from the increasing globalization of clinical research: no matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting," explained EMA. "Yet regulators, healthcare professionals and patients worldwide all rely on the same trial data when making decisions on whether to allow a medicine on the market or not and on whether to use a medicine or not."

The reflection paper seeks to lay out a two-part framework for generating solutions:

• firstly, by putting forward concrete steps for international cooperation in the regulation of clinical trials, with a specific emphasis on capacity-building initiatives for a common approach to oversight of trials
• secondly, by clarifying and determining the practical steps by which EU regulators will gain assurance that ethical and GCP standards are applied to clinical trials for human medicines, both during the development and during the marketing-authorization-application phase.

The reflection paper also puts forth several proposed actions and solutions, including:

• non-compliance that significantly affects the rights, safety or well-being of the subjects or the quality and integrity of the data reported is not acceptable, and will result in rejection of data and/or other regulatory actions;
• any data generated from a clinical trial for which the protocol was not submitted to an independent ethics committee should be disregarded when evaluating a marketing authorization application;
• any data generated from a clinical trial conducted without the informed consent of the trial subjects (or their legal representative where that is foreseen) should also be disregarded;
• as part of their applications for marketing authorizations, pharmaceutical companies should provide EU regulators with information summarizing the conduct of the trial and its compliance with ethical and GCP standards;
• the public assessment report should describe the assessment of the compliance with ethical and GCP standards.

Read more:

EMA - Towards a robust global framework for conduct and oversight of clinical trials