At the DAIRI in the Piedmont Region (Italy), a project of the reorganization of the start-up phase led to a reduction from 218 to 56 days of the clinical trial activation process.

During the course of the project, an implementation and reorganization of the staff was also carried out. The turnover of staff involved in this process had a negative impact on the average timelines for the last quarter of 2020 and the first quarter of 2021. This critical issue was agilely overcome thanks to the expertise developed by the working group composed by healthcare (e.g., biologist, research coordinators and data mangers) and administrative staff, which enabled the new staff involved to be trained quickly. This can be observed because the average times monitored in the second quarter of 2021 decreased further compared to those in the second quarter of 2020.

The importance of having trained staff in these specific activities was also observed in another reorganization project [10].

Despite the fact that the project was conducted during the COVID-19 pandemic, we did not identify any factors related to this that may have positively or negatively influenced the average timing of the activation phase of the studies. The studies on this specific topic were not included in the project precisely to avoid a bias because the COVID-19 trials’ activation process was fast-tracked, given the emergency status, according to national legislation.

Active participation in the project to reorganize the clinical trials’ authorization process by all the staff of the three facilities involved enabled them to gain the ability to analyze any criticalities that arise along the way and, through discussion in scheduled meetings, to develop additional countermeasures to facilitate the process.

Among the countermeasures taken that led to the reduced timelines was the identification and training of a group of data managers who check the completeness and assess the suitability of documents before the EC meeting, maintaining contact with the sponsor, principal investigator, clinical research organization (CRO), and ECS. This reduced the number of documentation integration requests from the EC, making the ethics approval phase faster.

In a further move to streamline the EC approval process, ECS compiles a draft opinion before each EC meeting, and once the study is approved, the approval is digitally signed by the EC chair.

The most effective countermeasure applied was to no longer run a linear pathway but to run it in parallel across sectors, as found in similar reorganization projects [10, 11]. According to the current process, the negotiation of the agreement begins in parallel with the evaluation conducted by the CTC, so that once the trial can be forwarded to the EC, the text of the agreement has already been finalized between the AO AL and the promoter (or its delegate). In addition, in order to simplify the agreement negotiation phase, the institution decided to adopt the draft agreement issued by the national authority in charge of drug studies (AIFA) and propose its use to sponsors and CROs.

Finally, in view of the fact that more and more sponsors are requesting digital signature of the agreement, it has been fully adopted, and the director general of the institute has delegated the signing of clinical trial agreements to the head of the AC.

A factor that influences the average timing of the activities carried out by the CTC is the parallel submission of interventional drug trials to the competent authority, coordinating ethics committee, and satellite ethics committee: according to regulations of the local ethics committee, it was not possible to release the approval until it was acquired the favorable approval issued by the coordinating EC. In the case of interventional drug trials, many times the documentation was taken over by the CTC, which carried out the scientific-technical evaluation but then could not proceed to submit the study to the EC.

This delay was eliminated with the full entry into force of the European Clinical Trials Regulation No. 536/14, which, for the activation of this specific type of study, removes the need to submit a trial to several ethics committees in the same country, requiring the approval of only one [6].

The time required to activate a trial is even longer for studies with agreement, because after approval by the institution, there are additional steps, which also depend on the rapidity of the sponsor’s response. This has also been highlighted at other centers that have conducted an analysis related to the management of the trial activation process [9,10,11].

Comparing the time reduction achieved with that found in other projects [12], it can be considered that the reorganization of the trial activation pathway was successful and that the pathway was fully standardized.