*EMA Update* Enhanced Access to Clinical Trial Information in Europe
The new version of the Clinical Trials Information System (CTIS) has been launched, providing earlier and more efficient access to clinical trial information in the European Union (EU) for patients, healthcare professionals, and other stakeholders. This improvement stems from revised transparency rules that have recently taken effect in Europe.
The earlier availability of information about approved clinical studies is a major development. Notably, the new regulations do away with the deferral mechanism that was in place previously and gave clinical trial sponsors the option to postpone disclosing specific data and documentation for up to seven years in order to safeguard economically sensitive information. The CTIS search now allows the public to view around 4,000 clinical studies that have issued decisions, according to the new regulations. Furthermore, every month, the CTIS site will receive about 500 newly authorised clinical studies, including existing experiments that have been transferred from the Clinical studies Directive. The CTIS public site will get additional features in the upcoming months to improve its general usability.
The amended rules strike a compromise between safeguarding commercially sensitive information and promoting transparency. They help patients by guaranteeing the early release of important clinical trial data that is thought to be most pertinent to them. In addition, they facilitate quicker access to information about clinical trials, enrolment opportunities, and awareness of prospective treatment alternatives for healthcare professionals. They help streamline operations for clinical trial sponsors and offer a more user-friendly system.
To assist sponsors in understanding the revised transparency rules, several resources have been developed, including a user guide and an overview of the data and documents to be published. Support activities, beginning with an event on 20 June open to all clinical trial sponsors, including pharmaceutical companies, contract research organizations, SMEs, and academic institutions, are also being organized.
The revised transparency rules were adopted by the EMA’s Management Board in October 2023, following a public consultation held between May and June 2023.
New CTIS Overview:
About CTIS
Sponsors and regulators use CTIS as a single point of entry for submitting and reviewing clinical trial applications inside the EU. In order to maintain the high degree of transparency required by the rule, it contains a publicly searchable database for patients, healthcare professionals, and the general public. While EU/EEA Member States are in charge of authorising and supervising clinical trials, the European Commission is in charge of enforcing the Clinical Trials Regulation, and the EMA is in charge of maintaining the CTIS.
Source: https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe
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