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With the primary aim of fostering research innovation and improving transparency of the clinical trial process in Europe, the Clinical Trials Regulation (CTR) was implemented in January of 2022. To facilitate the implementation and management of the CTR, the EMA simultaneously launched a digital portal known as Clinical Trials Information System (CTIS). Beginning January 31, 2023, all new clinical trial applications must be submitted via the CTIS.
These changes are leading a cultural shift in clinical trial transparency [See: A Cultural Shift Is Happening] and the operational impact of this change needs to be discussed in further detail.
The EMA has elevated transparency and disclosure of in-process and approved trials to another level. With the CTR, transparency has become an integral part of the clinical trial process in Europe. Using the CTIS, a publicly accessible database, anyone interested in the clinical trials conducted in Europe can search to obtain useful information. Interested parties may be current patients being treated for a disease or chronic illness, participants of a clinical trial seeking detailed information regarding his or her trial, researchers who are seeking details about past and in-process trials and their results, and everyday citizens seeking knowledge of a disease or treatment.
Increased transparency will help to mitigate redundancy or duplication of clinical trial initiatives. If a clinical trial had negative or inconclusive results, the CTIS will make this trial information available to researchers and individuals. For pharmaceutical companies, this visibility will help in avoiding the repetition of unsuccessful study designs. Increased transparency also helps in improving the quality of data. In other words, the structure and workflow that the CTIS requires is providing clarity and consistency in what stakeholders can expect when querying clinical trials in Europe.
In a nutshell, although these increased transparency requirements brought about by the CTR will trigger changes to pharmaceutical company’s current workflow, embracing transparency as a high value component in clinical trials will help to expedite research in a given therapy area while building trust and confidence with the public who seek to learn and understand about the trial itself.
Operationally, based on the information that is required in CTIS about a particular clinical trial, study sponsors need to assume all trial documents and information will become public, with few exceptions. All functional teams must understand that disclosure is now an integral part of the clinical process and prepare submission documents accordingly.
How can trial sponsors manage this change?
Over the next several years, as the industry embraces this change, the resulting impact to clinical teams and risks brought about with the disclosure of clinical documents and Commercially Confidential Information (CCI) must be managed carefully. Study sponsors may need to conduct a review of existing processes such as medical writing practices and awareness training regarding transparency of confidential information. A gap analysis of roles, responsibilities, tasks, internal policies and procedures may be required. Study sponsors may choose to start with foundational aspects such as how end-to-end CTR information flow will be managed in addition to the preparation of public version documents. Further, a risk-based approach to anonymizing personal data will be a necessary step in the process before sharing trial results and patient narratives.
As of January 31, 2023, the use of CTIS for new trial applications is mandatory. Study sponsors need to assess their internal capabilities, map their updated business processes, prioritize action items and seek support from vendors who specialize in identification of personal data and can support the redaction and anonymization of this information in a timely manner.
Transparency requirements have indeed disrupted the historical workflows previously implemented by study sponsors and CROs. Study sponsors are looking for more guidance during these times of change. The EMA has provided guidance documentation for study sponsors which is a good place to start. Additionally, to cope with the increased workload related to standardized document templates and document redactions, some companies are choosing to collaborate with external software and service providers such as Real Life Sciences (RLS).
Redactions can be less stressful purpose built digital tools are used to complete the document redaction and anonymization tasks. At RLS, solutions such as RLS Protect can help to automate the identification of personal data and confidential information and prepare public version documents. However, minimizing the need for redactions is one strategy that study sponsors can adopt. In the next blog of this series, let’s delve deeper into “lean” authoring...