The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable today in Europe.
One of the key changes is earlier availability of information on authorised clinical trials. Importantly, the new rules eliminate the previously available deferral mechanism, which allowed clinical trial sponsors to delay publishing certain data and documents for up to seven years after a trial’s completion to protect commercially confidential information. Under the new rules, approximately 4,000 clinical trials with issued decisions are now publicly accessible through the CTIS search. The CTIS portal will add approximately 500 newly authorised clinical trials per month. This includes ongoing trials that have been transitioned to CTIS from the Clinical Trials Directive. Over the next few months, additional features will be added to the CTIS public portal to further enhance overall usability…
