A Cultural Shift is Happening Before our Eyes - The Impact of the European Medicines Agency's (EMA) CTR & CTIS on Clinical Trial Transparency

The rollout of the Clinical Trial Information System (CTIS) has resulted in a cultural shift in the ways in which study sponsor leaders and operational teams think about clinical trial transparency and how this impacts their planning and operations. A primary aim of the Clinical Trial Regulation (CTR) EU No 536/2014, improving clinical trial transparency, will help to enhance trust and confidence with the public and provide material benefit in aiding and improving research. However, the operational impacts of CTIS and how clinical trials are managed in conformance with the Regulation in Europe is igniting changes that are far reaching within the organization. These changes will be adopted through well defined SOPs and a clear understanding of roles and responsibilities for clinical teams and their counterparts. Study sponsors that choose to embrace the change holistically by building a transparency minded culture throughout the organization will wind up on top. 

What History Tells Us?

Transparency requirements have evolved and progressed for years. In 2017, the European Medicines Agency (EMA) published external guidance for Policy 0070, and in 2019, Health Canada published a Public Release of Clinical Information (HC PRCI) guidance. The pharma industry has gradually become accustomed to disclosing trial results. Some have progressed to sharing beyond what is mandated by regional health authorities. The documents for sharing results may include trial synopsis, layperson summaries, and Clinical Study Reports (CSRs), for example. 

In 2022, the EMA launched the CTIS, and in 2023, its use will become mandatory for new clinical trials. The transparency requirements implemented as a result of the CTR has brought several questions and issues to the forefront.

What are the Aims of the Clinical Trial Regulation?

Few regulations have impacted pharmaceutical manufacturers more than Regulation (EU) No 536/2014, otherwise known as The Clinical Trials Regulation or CTR. The CTR aims to centralize the regulatory submission and review process for all trials conducted in the twenty-seven (27) European Economic Union countries. The intent is to position Europe as a favorable region to conduct clinical trials while increasing the transparency of clinical trials information to the public at large.

The CTIS is the secure online portal that is used for the implementation and operation of the CTR. This portal facilitates interactions between study sponsors, researchers, regulatory bodies and ethics committees throughout the lifecycle of a clinical trial. The public can also access a subset of trial information from the portal. The effort to centralize and streamline the clinical trial process in Europe using the CTIS has had a widespread impact on the operational teams that coordinate and manage clinical trials. To provide further clarity, leading up to the launch of CTIS, the EMA published guidance to use the CTIS, which has completely changed current conversations around clinical trial transparency. 

Why is the cultural shift happening? 

Apart from the use of CTIS, the transparency requirements alone have caused manufacturers to rethink their approach to clinical transparency and the ways their cross-functional teams think about and manage the regulatory process. For example, CTR’s transparency requirements have brought changes to what trial information and documentation is disclosed to the public and when. Five important needs draw our attention now: 

• The need to share detailed information about the trial as it is happening rather than after the trial results are analyzed. 

• The need to adjust processes, roles and responsibilities, standard operating procedures, and critical operational decision-making to ensure the trial adheres to the regulation’s detailed expectations. 

• The need to rethink regulatory document authoring practices to minimize document redaction workload and drive consistency within and across trials. 

• The need to protect and anonymize personal data and Commercially Confidential Information published via the CTIS while remaining in compliance with GDPR.

• The need to organize cross-functional teams to respond quickly to Member State questions in accordance with the regulation which may include updates to core regulatory documents that require redaction and local language translation.

This combination of requirements has triggered study sponsors to rethink how their teams work together to achieve this new set of expectations. As a result, the importance of a common understanding of what clinical transparency means, how it’s implemented and supported, and ultimately how it can be embraced must be tackled not only through roles, procedures, and processes but also how it is weaved in the cultural fabric of the organization.   

How do we embrace this cultural shift? 

Pharma leaders and regulatory affairs teams are looking for solutions that will help them adapt to the current evolving landscape and seamlessly integrate CTIS into their internal day-to-day workflow. These solutions include digital tools, streamlined processes, and expert teams that can help manage the transition. Real Life Sciences (RLS) has been at the forefront of developing and implementing solutions for current clinical transparency challenges.

This 6-part blog series will focus on the high-impact areas being realized by pharmaceutical manufacturers today. Our experts will share their perspectives and observations on how study sponsors can implement changes to improve operational efficiency and employee satisfaction while embracing the new world of clinical transparency we find ourselves in. Together, these focus areas make up the challenges and opportunities that are upon us in clinical transparency.